Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2026-02-18 @ 12:21 AM
Study NCT ID:
NCT02701257
Status:
TERMINATED
Last Update Posted:
2019-11-18
First Post:
2016-02-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The iLet Introduction Study: A Feasibility Study of the iLet, a Fully Integrated Bihormonal Bionic Pancreas
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005934', 'term': 'Glucagon'}], 'ancestors': [{'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cballiro@partners.org', 'phone': '617-726-1242', 'title': 'Courtney Balliro', 'organization': 'MGH Diabetes Research Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The original planned experiments and infusion set sub study were terminated early due to infusion site failures before the planned cohorts were completed. Changes to the infusion set design will be implemented prior to initiating any future studies.'}}, 'adverseEventsModule': {'timeFrame': 'During study visits up to 8 hours long', 'description': 'There were no participants at risk for Serious Adverse Events, All-Cause Mortality and any other adverse events in the arm using the iLet bionic pancreas with Xerisol glucagon, because that arm was not conducted.', 'eventGroups': [{'id': 'EG000', 'title': 'iPhone Bionic Pancreas - Lilly Glucagon', 'description': 'iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'iLet Bionic Pancreas - Lilly Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 7, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'iLet Bionic Pancreas - Xerisol Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nXeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'iLet Infusion Set', 'description': 'iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Contact Detach', 'description': 'Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hyperglycemia', 'notes': 'Hyperglycemia (may or may not include associated ketosis and vomiting) found to be associated with insulin infusion set failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Average Percent Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump (Aggregate of Both Insulin and Glucagon Doses)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'iPhone Bionic Pancreas - Lilly Glucagon', 'description': 'iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG001', 'title': 'iLet Bionic Pancreas - Lilly Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG002', 'title': 'iLet Bionic Pancreas - Xerisol Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nXeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump'}, {'id': 'OG003', 'title': 'iLet Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\niLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}, {'id': 'OG004', 'title': 'Contact Detach Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\nContact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.6', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '95.0', 'spread': '12.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 hours', 'description': 'Average percent dose amounts calculated by the bionic pancreas control algorithm that are successfully delivered by the pump (aggregate of both insulin and glucagon doses) - primary outcome for iPhone-based BP using Lilly glucagon vs. iLet BP using Lilly glucagon', 'unitOfMeasure': 'percentage of doses delivered', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.'}, {'type': 'PRIMARY', 'title': 'Average Percent Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump (Glucagon Doses).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'iPhone Bionic Pancreas - Lilly Glucagon', 'description': 'iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG001', 'title': 'iLet Bionic Pancreas - Lilly Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG002', 'title': 'iLet Bionic Pancreas - Xerisol Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nXeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump'}, {'id': 'OG003', 'title': 'iLet Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\niLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}, {'id': 'OG004', 'title': 'Contact Detach Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\nContact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}], 'classes': [{'categories': [{'measurements': [{'value': '96.6', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '100.0', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 hours', 'description': 'Average percent dose amounts calculated by the bionic pancreas control algorithm that are successfully delivered by the pump (glucagon doses) - - primary outcome for iLet BP using Lilly glucagon vs. iLet BP using Xeris Xerisol glucagon', 'unitOfMeasure': 'percentage of doses', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis only applies to the iLet BP using Lilly glucagon vs the iLet BP using Xerisol glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. Data for this outcome is reported for the iPhone BP and iLet BP arms using Lilly glucagon. This analysis does not apply to the infusion set sub study.'}, {'type': 'PRIMARY', 'title': 'Insulin Area Under the Curve in the 3.5 Hours Following the Insulin Bolus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'iPhone Bionic Pancreas - Lilly Glucagon', 'description': 'iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG001', 'title': 'iLet Bionic Pancreas - Lilly Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG002', 'title': 'iLet Bionic Pancreas - Xerisol Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nXeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump'}, {'id': 'OG003', 'title': 'iLet Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\niLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}, {'id': 'OG004', 'title': 'Contact Detach Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\nContact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}], 'timeFrame': '3.5 hours following insulin bolus', 'description': 'This applies only to the infusion set sub-study', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome only applies to the infusion set sub study, the other arms were not analyzed. The infusion set sub study was terminated and the insulin assays were not completed.'}, {'type': 'SECONDARY', 'title': 'Average Continuous Glucose Monitor (CGM) Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'iPhone Bionic Pancreas - Lilly Glucagon', 'description': 'iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG001', 'title': 'iLet Bionic Pancreas - Lilly Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG002', 'title': 'iLet Bionic Pancreas - Xerisol Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nXeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump'}, {'id': 'OG003', 'title': 'iLet Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\niLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}, {'id': 'OG004', 'title': 'Contact Detach Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\nContact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}], 'classes': [{'categories': [{'measurements': [{'value': '179.2', 'spread': '37.5', 'groupId': 'OG000'}, {'value': '251.2', 'spread': '80.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 hours', 'description': 'The average glucose according to continuous glucose monitor readings. This only applies to the iPhone vs. iLet BP experiments.', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.'}, {'type': 'SECONDARY', 'title': 'Percentage of Time in Each of the Following Ranges: < 50 mg/dl, < 60 mg/dl, <70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, >180 mg/dl, >250 mg/dl', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'iPhone Bionic Pancreas - Lilly Glucagon', 'description': 'iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG001', 'title': 'iLet Bionic Pancreas - Lilly Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG002', 'title': 'iLet Bionic Pancreas - Xerisol Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nXeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump'}, {'id': 'OG003', 'title': 'iLet Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\niLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}, {'id': 'OG004', 'title': 'Contact Detach Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\nContact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}], 'classes': [{'title': 'CGM glucose < 60', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '0.36', 'spread': '1.07', 'groupId': 'OG001'}]}]}, {'title': 'CGM glucose > 180', 'categories': [{'measurements': [{'value': '39.0', 'spread': '24.5', 'groupId': 'OG000'}, {'value': '67.5', 'spread': '21.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 hours', 'description': 'Percentage of time subjects spent in each of these ranges based on continuous glucose monitor readings. This only applies to the iPhone vs iLet BP visits.', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Mean CGM Glucose < 154 mg/dl', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'iPhone Bionic Pancreas - Lilly Glucagon', 'description': 'iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG001', 'title': 'iLet Bionic Pancreas - Lilly Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG002', 'title': 'iLet Bionic Pancreas - Xerisol Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nXeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump'}, {'id': 'OG003', 'title': 'iLet Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\niLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}, {'id': 'OG004', 'title': 'Contact Detach Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\nContact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 hours', 'description': 'The number of subjects who achieved a mean CGM glucose \\< 154 mg/dl, which correlates to an estimated hemoglobin a1c of 7%, which is the ADA goal for therapy. This applies only to the iPhone vs iLet BP experiments', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.'}, {'type': 'SECONDARY', 'title': 'Number of Severe Hypoglycemic Events (Subject Unable to Self-treat, Requiring the Assistance of Another Person)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'iPhone Bionic Pancreas - Lilly Glucagon', 'description': 'iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG001', 'title': 'iLet Bionic Pancreas - Lilly Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG002', 'title': 'iLet Bionic Pancreas - Xerisol Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nXeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump'}, {'id': 'OG003', 'title': 'iLet Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\niLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}, {'id': 'OG004', 'title': 'Contact Detach Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\nContact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 hours', 'description': 'The number of severe hypoglycemic events subjects experience. This applies only to the iPhone vs iLet BP experiments.', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.'}, {'type': 'SECONDARY', 'title': 'Average Percent Insulin Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'iPhone Bionic Pancreas - Lilly Glucagon', 'description': 'iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG001', 'title': 'iLet Bionic Pancreas - Lilly Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG002', 'title': 'iLet Bionic Pancreas - Xerisol Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nXeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump'}, {'id': 'OG003', 'title': 'iLet Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\niLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}, {'id': 'OG004', 'title': 'Contact Detach Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\nContact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.0', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '95.8', 'spread': '13.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 hours', 'description': 'The average percentage of successfully delivered insulin doses. This applies only to the iPhone vs iLet BP experiments.', 'unitOfMeasure': 'percentage of doses', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.'}, {'type': 'SECONDARY', 'title': 'Average Percent Glucagon Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'iPhone Bionic Pancreas - Lilly Glucagon', 'description': 'iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG001', 'title': 'iLet Bionic Pancreas - Lilly Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG002', 'title': 'iLet Bionic Pancreas - Xerisol Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nXeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump'}, {'id': 'OG003', 'title': 'iLet Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\niLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}, {'id': 'OG004', 'title': 'Contact Detach Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\nContact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}], 'classes': [{'categories': [{'measurements': [{'value': '96.6', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '100.0', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 hours', 'description': 'The average percentage of successfully delivered glucagon doses. This applies only to the iPhone vs iLet BP experiments.', 'unitOfMeasure': 'percentage of doses', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.'}, {'type': 'SECONDARY', 'title': 'Average Percent Insulin Dose Amounts Successfully Issued to the Pump by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'iPhone Bionic Pancreas - Lilly Glucagon', 'description': 'iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG001', 'title': 'iLet Bionic Pancreas - Lilly Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG002', 'title': 'iLet Bionic Pancreas - Xerisol Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nXeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump'}, {'id': 'OG003', 'title': 'iLet Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\niLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}, {'id': 'OG004', 'title': 'Contact Detach Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\nContact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.5', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '96.1', 'spread': '13.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 hours', 'description': 'The average percentage of successfully issued insulin doses that are then delivered successfully by the pump. This applies only to the iPhone vs iLet BP experiments.', 'unitOfMeasure': 'percentage of doses', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.'}, {'type': 'SECONDARY', 'title': 'Average Percent Glucagon Dose Amounts Successfully Issued to the Pump by the Bionic Pancreas Control Algorithm That a Successfully Delivered by the Pump.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'iPhone Bionic Pancreas - Lilly Glucagon', 'description': 'iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG001', 'title': 'iLet Bionic Pancreas - Lilly Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG002', 'title': 'iLet Bionic Pancreas - Xerisol Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nXeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump'}, {'id': 'OG003', 'title': 'iLet Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\niLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}, {'id': 'OG004', 'title': 'Contact Detach Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\nContact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}], 'classes': [{'categories': [{'measurements': [{'value': '96.6', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '100.0', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 hours', 'description': 'The average percentage of successfully issued glucagon doses that are then delivered successfully by the pump. This applies only to the iPhone vs iLet BP experiments.', 'unitOfMeasure': 'percentage of doses', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.'}, {'type': 'SECONDARY', 'title': 'Average Percent of 5 Minute Steps During Which the Bionic Pancreas is Functioning Nominally in All Respects Based on Real-time CGM Data (New CGM Glucose Reading Captured, Dose Calculated, Dose Issued to Pumps', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'iPhone Bionic Pancreas - Lilly Glucagon', 'description': 'iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG001', 'title': 'iLet Bionic Pancreas - Lilly Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG002', 'title': 'iLet Bionic Pancreas - Xerisol Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nXeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump'}, {'id': 'OG003', 'title': 'iLet Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\niLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}, {'id': 'OG004', 'title': 'Contact Detach Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\nContact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}], 'classes': [{'categories': [{'measurements': [{'value': '88.9', 'spread': '0.073', 'groupId': 'OG000'}, {'value': '75.1', 'spread': '0.196', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 hours', 'description': 'The percentage of time (measured in 5 minute "steps") that the bionic pancreas is working, indicated by the presence of a CGM reading, a successful dose calculation and successful issuing of a dose. This applies only to the iPhone vs iLet BP experiments.', 'unitOfMeasure': 'percentage of 5 minute steps', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted.'}, {'type': 'SECONDARY', 'title': 'Average Percent of 5 Minute Steps During Which the Bionic Pancreas is Functioning Nominally With or Without a New CGM Glucose Reading Captured (Dose Calculated, Dose Issued to Pumps).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'iPhone Bionic Pancreas - Lilly Glucagon', 'description': 'iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG001', 'title': 'iLet Bionic Pancreas - Lilly Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG002', 'title': 'iLet Bionic Pancreas - Xerisol Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nXeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump'}, {'id': 'OG003', 'title': 'iLet Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\niLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}, {'id': 'OG004', 'title': 'Contact Detach Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\nContact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.6', 'spread': '0.054', 'groupId': 'OG000'}, {'value': '99.8', 'spread': '0.004', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 hours', 'description': 'The percentage of time (measured in 5 minute "steps") that the bionic pancreas is working even without a CGM reading being present, indicated by a successful dose calculation and successful issuing of a dose. This applies only to the iPhone vs iLet BP experiments.', 'unitOfMeasure': 'percentage of 5 minutes steps', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted.'}, {'type': 'SECONDARY', 'title': 'CGM Reliability Index, Calculated as Percent of Possible Values Actually Recorded by CGM.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'iPhone Bionic Pancreas - Lilly Glucagon', 'description': 'iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG001', 'title': 'iLet Bionic Pancreas - Lilly Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG002', 'title': 'iLet Bionic Pancreas - Xerisol Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nXeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump'}, {'id': 'OG003', 'title': 'iLet Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\niLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}, {'id': 'OG004', 'title': 'Contact Detach Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\nContact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.1', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '75.1', 'spread': '0.19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 hours', 'description': 'A measure of CGM reliability, indicating the percentage of values the CGM displayed out of the total values it should have displayed in that time. This applies only to the iPhone vs iLet BP experiments.', 'unitOfMeasure': 'percentage of CGM values', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted.'}, {'type': 'SECONDARY', 'title': 'Glucagon Total Delivery Per kg of Body Mass.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'iPhone Bionic Pancreas - Lilly Glucagon', 'description': 'iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG001', 'title': 'iLet Bionic Pancreas - Lilly Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG002', 'title': 'iLet Bionic Pancreas - Xerisol Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nXeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump'}, {'id': 'OG003', 'title': 'iLet Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\niLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}, {'id': 'OG004', 'title': 'Contact Detach Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\nContact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.60', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '1.12', 'spread': '1.71', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 hours', 'description': 'The average total glucagon delivered by the bionic pancreas. This applies only to the iPhone vs iLet BP experiments.', 'unitOfMeasure': 'mcg/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.'}, {'type': 'SECONDARY', 'title': 'Insulin Total Delivery Per kg of Body Mass.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'iPhone Bionic Pancreas - Lilly Glucagon', 'description': 'iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG001', 'title': 'iLet Bionic Pancreas - Lilly Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG002', 'title': 'iLet Bionic Pancreas - Xerisol Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nXeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump'}, {'id': 'OG003', 'title': 'iLet Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\niLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}, {'id': 'OG004', 'title': 'Contact Detach Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\nContact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.22', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '0.23', 'spread': '0.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 hours', 'description': 'The average total insulin delivered by the bionic pancreas. This applies only to the iPhone vs iLet BP experiments.', 'unitOfMeasure': 'units/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.'}, {'type': 'SECONDARY', 'title': 'Number of Episodes of Symptomatic Hypoglycemia.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'iPhone Bionic Pancreas - Lilly Glucagon', 'description': 'iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG001', 'title': 'iLet Bionic Pancreas - Lilly Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG002', 'title': 'iLet Bionic Pancreas - Xerisol Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nXeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump'}, {'id': 'OG003', 'title': 'iLet Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\niLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}, {'id': 'OG004', 'title': 'Contact Detach Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\nContact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 hours', 'description': 'Number of time subjects experienced symptoms of hypoglycemia and reported that to study staff. This applies only to the iPhone vs iLet BP experiments.', 'unitOfMeasure': 'number of episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.'}, {'type': 'SECONDARY', 'title': 'Total Grams of Carbohydrate Taken for Hypoglycemia.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'iPhone Bionic Pancreas - Lilly Glucagon', 'description': 'iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG001', 'title': 'iLet Bionic Pancreas - Lilly Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG002', 'title': 'iLet Bionic Pancreas - Xerisol Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nXeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump'}, {'id': 'OG003', 'title': 'iLet Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\niLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}, {'id': 'OG004', 'title': 'Contact Detach Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\nContact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 hours', 'description': 'The total grams of carbohydrates given to subjects for treatment of hypoglycemia. This applies only to the iPhone vs iLet BP experiments.', 'unitOfMeasure': 'number of grams of carbohydrates', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.'}, {'type': 'SECONDARY', 'title': 'Difference in Mean Nausea From VAS During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'iPhone Bionic Pancreas - Lilly Glucagon', 'description': 'iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG001', 'title': 'iLet Bionic Pancreas - Lilly Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG002', 'title': 'iLet Bionic Pancreas - Xerisol Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nXeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump'}, {'id': 'OG003', 'title': 'iLet Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\niLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}, {'id': 'OG004', 'title': 'Contact Detach Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\nContact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.47', 'spread': '10.47', 'groupId': 'OG000'}, {'value': '6.93', 'spread': '15.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 hours', 'description': 'This applies only the iPhone vs. iLet BP experiments. Subjects were given a visual analog scale measuring 100 mm and asked to draw a line to indicate their level of nausea at timepoints during the study with 100 being the "worst possible nausea" and 0 being "no nausea".', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.'}, {'type': 'SECONDARY', 'title': 'Average Insulin Infusion Site Pain From VAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'iPhone Bionic Pancreas - Lilly Glucagon', 'description': 'iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG001', 'title': 'iLet Bionic Pancreas - Lilly Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG002', 'title': 'iLet Bionic Pancreas - Xerisol Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nXeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump'}, {'id': 'OG003', 'title': 'iLet Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\niLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}, {'id': 'OG004', 'title': 'Contact Detach Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\nContact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.49', 'spread': '3.06', 'groupId': 'OG000'}, {'value': '6.61', 'spread': '13.04', 'groupId': 'OG001'}, {'value': '0.54', 'spread': '2.61', 'groupId': 'OG003'}, {'value': '2.42', 'spread': '9.98', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 hours', 'description': 'This applies to the iPhone vs. iLet BP experiments and the infusion set sub-study experiments. Subjects were given a visual analog scale measuring 100 mm and asked to draw a line to indicate their level of pain at timepoints during the study with 100 being the "worst possible pain" and 0 being "no pain".', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The experimental arm with the iLet BP using Xeris glucagon was never conducted. Analysis includes 9 subjects that completed both the BP visits and 4 subjects that completed both infusion set sub study visits.'}, {'type': 'SECONDARY', 'title': 'Difference in Local Erythema and Edema According to the Draize Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'iPhone Bionic Pancreas - Lilly Glucagon', 'description': 'iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG001', 'title': 'iLet Bionic Pancreas - Lilly Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG002', 'title': 'iLet Bionic Pancreas - Xerisol Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nXeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump'}, {'id': 'OG003', 'title': 'iLet Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\niLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}, {'id': 'OG004', 'title': 'Contact Detach Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\nContact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}, {'value': '0', 'spread': '0', 'groupId': 'OG003'}, {'value': '0', 'spread': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 hours', 'description': 'This applies to the iPhone vs. iLet BP experiments and the infusion set sub-study experiments. The draize scale assess erythema, eschar and edema using a score from 0-4, with 4 meaning a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The experimental arm with the iLet BP using Xeris glucagon was never conducted. Analysis includes 9 subjects that completed both the BP visits and 4 subjects that completed both infusion set sub study visits.'}, {'type': 'SECONDARY', 'title': 'Number of Unscheduled Infusion Set Replacements.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'iPhone Bionic Pancreas - Lilly Glucagon', 'description': 'iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG001', 'title': 'iLet Bionic Pancreas - Lilly Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG002', 'title': 'iLet Bionic Pancreas - Xerisol Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nXeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump'}, {'id': 'OG003', 'title': 'iLet Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\niLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}, {'id': 'OG004', 'title': 'Contact Detach Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\nContact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 hours', 'description': 'This applies to the iPhone vs. iLet BP experiments and the infusion set sub-study experiments.', 'unitOfMeasure': 'number of infusion set changes', 'reportingStatus': 'POSTED', 'populationDescription': 'The experimental arm with the iLet BP using Xeris glucagon was never conducted. Analysis includes 9 subjects that completed both the BP visits and 4 subjects that completed both infusion set sub study visits.'}, {'type': 'SECONDARY', 'title': 'Number of Unscheduled CGM Sensor Changes.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'iPhone Bionic Pancreas - Lilly Glucagon', 'description': 'iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG001', 'title': 'iLet Bionic Pancreas - Lilly Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG002', 'title': 'iLet Bionic Pancreas - Xerisol Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nXeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump'}, {'id': 'OG003', 'title': 'iLet Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\niLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}, {'id': 'OG004', 'title': 'Contact Detach Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\nContact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 hours', 'description': 'This applies only to the iPhone vs. iLet BP experiments', 'unitOfMeasure': 'number of sensor changes', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.'}, {'type': 'SECONDARY', 'title': 'Insulin Area Under the Curve During the Initial 90 Minute Fasted Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'iPhone BP First, Then iLet BP (Lilly gLucagon)', 'description': 'iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily\n\niLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.'}, {'id': 'OG001', 'title': 'iLet BP First, Then iPhone BP (Lilly Glucagon)', 'description': 'iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily\n\niLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.'}, {'id': 'OG002', 'title': 'iLet Bionic Pancreas - Xerisol Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nXeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump'}, {'id': 'OG003', 'title': 'iLet Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\niLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}, {'id': 'OG004', 'title': 'Contact Detach Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\nContact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}], 'timeFrame': '8 hours', 'description': 'This applies only to the infusion set sub-study', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome only applies to the infusion set sub study, the other arms were not analyzed. The infusion set sub study was terminated and the insulin assays were not completed.'}, {'type': 'SECONDARY', 'title': 'Mean Insulin Levels During the Initial 90 Minute Fasted Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'iPhone Bionic Pancreas - Lilly Glucagon', 'description': 'iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG001', 'title': 'iLet Bionic Pancreas - Lilly Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG002', 'title': 'iLet Bionic Pancreas - Xerisol Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nXeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump'}, {'id': 'OG003', 'title': 'iLet Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\niLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}, {'id': 'OG004', 'title': 'Contact Detach Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\nContact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}], 'timeFrame': '8 hours', 'description': 'This applies only to the infusion set sub-study', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome only applies to the infusion set sub study, the other arms were not analyzed. The infusion set sub study was terminated and the insulin assays were not completed.'}, {'type': 'SECONDARY', 'title': 'Difference Between Insulin Levels at Baseline and at 90 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'iPhone Bionic Pancreas - Lilly Glucagon', 'description': 'iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG001', 'title': 'iLet Bionic Pancreas - Lilly Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG002', 'title': 'iLet Bionic Pancreas - Xerisol Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nXeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump'}, {'id': 'OG003', 'title': 'iLet Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\niLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}, {'id': 'OG004', 'title': 'Contact Detach Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\nContact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}], 'timeFrame': '8 hours', 'description': 'This applies only to the infusion set sub-study', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome only applies to the infusion set sub study, the other arms were not analyzed. The infusion set sub study was terminated and the insulin assays were not completed.'}, {'type': 'SECONDARY', 'title': 'Tmax After the Insulin Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'iPhone Bionic Pancreas - Lilly Glucagon', 'description': 'iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG001', 'title': 'iLet Bionic Pancreas - Lilly Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG002', 'title': 'iLet Bionic Pancreas - Xerisol Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nXeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump'}, {'id': 'OG003', 'title': 'iLet Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\niLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}, {'id': 'OG004', 'title': 'Contact Detach Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\nContact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}], 'timeFrame': '8 hours', 'description': 'This applies only to the infusion set sub-study', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome only applies to the infusion set sub study, the other arms were not analyzed. The infusion set sub study was terminated and the insulin assays were not completed.'}, {'type': 'SECONDARY', 'title': 'T 1/2 Max After the Insulin Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'iPhone Bionic Pancreas - Lilly Glucagon', 'description': 'iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG001', 'title': 'iLet Bionic Pancreas - Lilly Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG002', 'title': 'iLet Bionic Pancreas - Xerisol Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nXeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump'}, {'id': 'OG003', 'title': 'iLet Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\niLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}, {'id': 'OG004', 'title': 'Contact Detach Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\nContact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}], 'timeFrame': '8 hours', 'description': 'This applies only to the infusion set sub-study', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome only applies to the infusion set sub study, the other arms were not analyzed. The infusion set sub study was terminated and the insulin assays were not completed.'}, {'type': 'SECONDARY', 'title': 'C Max After the Insulin Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'iPhone Bionic Pancreas - Lilly Glucagon', 'description': 'iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG001', 'title': 'iLet Bionic Pancreas - Lilly Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG002', 'title': 'iLet Bionic Pancreas - Xerisol Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nXeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump'}, {'id': 'OG003', 'title': 'iLet Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\niLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}, {'id': 'OG004', 'title': 'Contact Detach Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\nContact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}], 'timeFrame': '8 hours', 'description': 'This applies only to the infusion set sub-study', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome only applies to the infusion set sub study, the other arms were not analyzed. The infusion set sub study was terminated and the insulin assays were not completed.'}, {'type': 'SECONDARY', 'title': 'AUC in the First 30 Minutes After the Insulin Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'iPhone Bionic Pancreas - Lilly Glucagon', 'description': 'iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG001', 'title': 'iLet Bionic Pancreas - Lilly Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG002', 'title': 'iLet Bionic Pancreas - Xerisol Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nXeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump'}, {'id': 'OG003', 'title': 'iLet Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\niLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}, {'id': 'OG004', 'title': 'Contact Detach Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\nContact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}], 'timeFrame': '8 hours', 'description': 'This applies only to the infusion set sub-study', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome only applies to the infusion set sub study, the other arms were not analyzed. The infusion set sub study was terminated and the insulin assays were not completed.'}, {'type': 'SECONDARY', 'title': 'AUC in the First 60 Minutes After the Insulin Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'iPhone Bionic Pancreas - Lilly Glucagon', 'description': 'iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG001', 'title': 'iLet Bionic Pancreas - Lilly Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG002', 'title': 'iLet Bionic Pancreas - Xerisol Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nXeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump'}, {'id': 'OG003', 'title': 'iLet Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\niLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}, {'id': 'OG004', 'title': 'Contact Detach Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\nContact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}], 'timeFrame': '8 hours', 'description': 'This applies only to the infusion set sub-study', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome only applies to the infusion set sub study, the other arms were not analyzed. The infusion set sub study was terminated and the insulin assays were not completed.'}, {'type': 'SECONDARY', 'title': 'AUC in the First 90 Minutes After the Insulin Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'iPhone Bionic Pancreas - Lilly Glucagon', 'description': 'iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG001', 'title': 'iLet Bionic Pancreas - Lilly Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG002', 'title': 'iLet Bionic Pancreas - Xerisol Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nXeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump'}, {'id': 'OG003', 'title': 'iLet Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\niLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}, {'id': 'OG004', 'title': 'Contact Detach Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\nContact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}], 'timeFrame': '8 hours', 'description': 'This applies only to the infusion set sub-study', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome only applies to the infusion set sub study, the other arms were not analyzed.The infusion set sub study was terminated and the insulin assays were not completed.'}, {'type': 'SECONDARY', 'title': 'Terminal Half Life After the Insulin Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'iPhone Bionic Pancreas - Lilly Glucagon', 'description': 'iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG001', 'title': 'iLet Bionic Pancreas - Lilly Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG002', 'title': 'iLet Bionic Pancreas - Xerisol Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nXeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump'}, {'id': 'OG003', 'title': 'iLet Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\niLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}, {'id': 'OG004', 'title': 'Contact Detach Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\nContact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}], 'timeFrame': '8 hours', 'description': 'This applies only to the infusion set sub-study', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome only applies to the infusion set sub study, the other arms were not analyzed. The infusion set sub study was terminated and the insulin assays were not completed.'}, {'type': 'SECONDARY', 'title': 'Difference Between the Fasted PG Value and the PG Value at 90 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'iPhone Bionic Pancreas - Lilly Glucagon', 'description': 'iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG001', 'title': 'iLet Bionic Pancreas - Lilly Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG002', 'title': 'iLet Bionic Pancreas - Xerisol Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nXeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump'}, {'id': 'OG003', 'title': 'iLet Infusion Set', 'description': 'iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}, {'id': 'OG004', 'title': 'Contact Detach Infusion Set', 'description': 'Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.7', 'spread': '28.7', 'groupId': 'OG003'}, {'value': '-6.7', 'spread': '41.8', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Fasted State and 90 Minutes', 'description': 'This applies only to the infusion set sub-study', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome only applies to the infusion set sub study, the other arms were not analyzed. The Overall Number of Participants Analyzed represents all Completed participants that received the intervention'}, {'type': 'SECONDARY', 'title': 'Difference in the PG Prior to the Meal and Peak Post-prandial Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'iPhone Bionic Pancreas - Lilly Glucagon', 'description': 'iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG001', 'title': 'iLet Bionic Pancreas - Lilly Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG002', 'title': 'iLet Bionic Pancreas - Xerisol Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nXeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump'}, {'id': 'OG003', 'title': 'iLet Infusion Set', 'description': 'iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}, {'id': 'OG004', 'title': 'Contact Detach Infusion Set', 'description': 'Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}], 'classes': [{'categories': [{'measurements': [{'value': '176.3', 'spread': '88.2', 'groupId': 'OG003'}, {'value': '73.9', 'spread': '76.8', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-meal PG value and peak PG value during the 3.5 hours following the meal.', 'description': 'This applies only to the infusion set sub-study', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome only applies to the infusion set sub study, the other arms were not analyzed. The Overall Number of Participants Analyzed represents all Completed participants that received the intervention'}, {'type': 'SECONDARY', 'title': 'PG AUC in the 3.5 Hours Following the Meal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'iPhone Bionic Pancreas - Lilly Glucagon', 'description': 'iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG001', 'title': 'iLet Bionic Pancreas - Lilly Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'OG002', 'title': 'iLet Bionic Pancreas - Xerisol Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nXeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump'}, {'id': 'OG003', 'title': 'iLet Infusion Set', 'description': 'iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}, {'id': 'OG004', 'title': 'Contact Detach Infusion Set', 'description': 'Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}], 'classes': [{'categories': [{'measurements': [{'value': '15512740', 'spread': '10050495', 'groupId': 'OG003'}, {'value': '8359871', 'spread': '5458714', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3.5 hours following the meal', 'description': 'This applies only to the infusion set sub-study', 'unitOfMeasure': 'mg*min/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome only applies to the infusion set sub study, the other arms were not analyzed. The Overall Number of Participants Analyzed represents all Completed participants that received the intervention'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'iPhone BP First, Then iLet BP (Lilly gLucagon)', 'description': 'iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily\n\niLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.'}, {'id': 'FG001', 'title': 'iLet BP First, Then iPhone BP (Lilly Glucagon)', 'description': 'iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily\n\niLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.'}, {'id': 'FG002', 'title': 'iLet Bionic Pancreas - Xerisol Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nXeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump'}, {'id': 'FG003', 'title': 'iLet Infusion Set First, Then Contact Detach', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\niLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.\n\nContact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}, {'id': 'FG004', 'title': 'Contact Detach Infusion Set First, Then iLet Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\nContact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.\n\niLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'iPhone Bionic Pancreas - Lilly Glucagon', 'description': 'iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed dailyy'}, {'id': 'BG001', 'title': 'iLet Bionic Pancreas - Lilly Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nLilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily'}, {'id': 'BG002', 'title': 'iLet Bionic Pancreas - Xerisol Glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.\n\niLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.\n\nXeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump'}, {'id': 'BG003', 'title': 'iLet Infusion Set First, Then Contact Detach', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\niLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.\n\nContact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}, {'id': 'BG004', 'title': 'Contact Detach First, Then iLet Infusion Set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.\n\nContact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.\n\niLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.6', 'spread': '22.3', 'groupId': 'BG000'}, {'value': '32.6', 'spread': '17.9', 'groupId': 'BG001'}, {'value': '48.8', 'spread': '14.7', 'groupId': 'BG003'}, {'value': '44.7', 'spread': '17.7', 'groupId': 'BG004'}, {'value': '39.7', 'spread': '17.5', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '19', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Hemoglobin A1c', 'classes': [{'categories': [{'measurements': [{'value': '8.3', 'spread': '0.7', 'groupId': 'BG000'}, {'value': '7.6', 'spread': '1.8', 'groupId': 'BG001'}, {'value': '6.9', 'spread': '1.2', 'groupId': 'BG003'}, {'value': '8.1', 'spread': '1.8', 'groupId': 'BG004'}, {'value': '7.8', 'spread': '1.2', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The study was terminated and the iLet BP arm with Xeris glucagon was never conducted.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-10-03', 'size': 778646, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-08-05T13:43', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'whyStopped': 'The study was terminated prior to completing the planned cohorts and analysis because of problems with the infusion set resulting in inadequate insulin delivery', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-15', 'studyFirstSubmitDate': '2016-02-29', 'resultsFirstSubmitDate': '2019-08-05', 'studyFirstSubmitQcDate': '2016-03-02', 'lastUpdatePostDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-15', 'studyFirstPostDateStruct': {'date': '2016-03-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average Percent Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump (Aggregate of Both Insulin and Glucagon Doses)', 'timeFrame': '8 hours', 'description': 'Average percent dose amounts calculated by the bionic pancreas control algorithm that are successfully delivered by the pump (aggregate of both insulin and glucagon doses) - primary outcome for iPhone-based BP using Lilly glucagon vs. iLet BP using Lilly glucagon'}, {'measure': 'Average Percent Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump (Glucagon Doses).', 'timeFrame': '8 hours', 'description': 'Average percent dose amounts calculated by the bionic pancreas control algorithm that are successfully delivered by the pump (glucagon doses) - - primary outcome for iLet BP using Lilly glucagon vs. iLet BP using Xeris Xerisol glucagon'}, {'measure': 'Insulin Area Under the Curve in the 3.5 Hours Following the Insulin Bolus', 'timeFrame': '3.5 hours following insulin bolus', 'description': 'This applies only to the infusion set sub-study'}], 'secondaryOutcomes': [{'measure': 'Average Continuous Glucose Monitor (CGM) Glucose', 'timeFrame': '8 hours', 'description': 'The average glucose according to continuous glucose monitor readings. This only applies to the iPhone vs. iLet BP experiments.'}, {'measure': 'Percentage of Time in Each of the Following Ranges: < 50 mg/dl, < 60 mg/dl, <70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, >180 mg/dl, >250 mg/dl', 'timeFrame': '8 hours', 'description': 'Percentage of time subjects spent in each of these ranges based on continuous glucose monitor readings. This only applies to the iPhone vs iLet BP visits.'}, {'measure': 'Number of Subjects With Mean CGM Glucose < 154 mg/dl', 'timeFrame': '8 hours', 'description': 'The number of subjects who achieved a mean CGM glucose \\< 154 mg/dl, which correlates to an estimated hemoglobin a1c of 7%, which is the ADA goal for therapy. This applies only to the iPhone vs iLet BP experiments'}, {'measure': 'Number of Severe Hypoglycemic Events (Subject Unable to Self-treat, Requiring the Assistance of Another Person)', 'timeFrame': '8 hours', 'description': 'The number of severe hypoglycemic events subjects experience. This applies only to the iPhone vs iLet BP experiments.'}, {'measure': 'Average Percent Insulin Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.', 'timeFrame': '8 hours', 'description': 'The average percentage of successfully delivered insulin doses. This applies only to the iPhone vs iLet BP experiments.'}, {'measure': 'Average Percent Glucagon Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.', 'timeFrame': '8 hours', 'description': 'The average percentage of successfully delivered glucagon doses. This applies only to the iPhone vs iLet BP experiments.'}, {'measure': 'Average Percent Insulin Dose Amounts Successfully Issued to the Pump by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.', 'timeFrame': '8 hours', 'description': 'The average percentage of successfully issued insulin doses that are then delivered successfully by the pump. This applies only to the iPhone vs iLet BP experiments.'}, {'measure': 'Average Percent Glucagon Dose Amounts Successfully Issued to the Pump by the Bionic Pancreas Control Algorithm That a Successfully Delivered by the Pump.', 'timeFrame': '8 hours', 'description': 'The average percentage of successfully issued glucagon doses that are then delivered successfully by the pump. This applies only to the iPhone vs iLet BP experiments.'}, {'measure': 'Average Percent of 5 Minute Steps During Which the Bionic Pancreas is Functioning Nominally in All Respects Based on Real-time CGM Data (New CGM Glucose Reading Captured, Dose Calculated, Dose Issued to Pumps', 'timeFrame': '8 hours', 'description': 'The percentage of time (measured in 5 minute "steps") that the bionic pancreas is working, indicated by the presence of a CGM reading, a successful dose calculation and successful issuing of a dose. This applies only to the iPhone vs iLet BP experiments.'}, {'measure': 'Average Percent of 5 Minute Steps During Which the Bionic Pancreas is Functioning Nominally With or Without a New CGM Glucose Reading Captured (Dose Calculated, Dose Issued to Pumps).', 'timeFrame': '8 hours', 'description': 'The percentage of time (measured in 5 minute "steps") that the bionic pancreas is working even without a CGM reading being present, indicated by a successful dose calculation and successful issuing of a dose. This applies only to the iPhone vs iLet BP experiments.'}, {'measure': 'CGM Reliability Index, Calculated as Percent of Possible Values Actually Recorded by CGM.', 'timeFrame': '8 hours', 'description': 'A measure of CGM reliability, indicating the percentage of values the CGM displayed out of the total values it should have displayed in that time. This applies only to the iPhone vs iLet BP experiments.'}, {'measure': 'Glucagon Total Delivery Per kg of Body Mass.', 'timeFrame': '8 hours', 'description': 'The average total glucagon delivered by the bionic pancreas. This applies only to the iPhone vs iLet BP experiments.'}, {'measure': 'Insulin Total Delivery Per kg of Body Mass.', 'timeFrame': '8 hours', 'description': 'The average total insulin delivered by the bionic pancreas. This applies only to the iPhone vs iLet BP experiments.'}, {'measure': 'Number of Episodes of Symptomatic Hypoglycemia.', 'timeFrame': '8 hours', 'description': 'Number of time subjects experienced symptoms of hypoglycemia and reported that to study staff. This applies only to the iPhone vs iLet BP experiments.'}, {'measure': 'Total Grams of Carbohydrate Taken for Hypoglycemia.', 'timeFrame': '8 hours', 'description': 'The total grams of carbohydrates given to subjects for treatment of hypoglycemia. This applies only to the iPhone vs iLet BP experiments.'}, {'measure': 'Difference in Mean Nausea From VAS During the Study', 'timeFrame': '8 hours', 'description': 'This applies only the iPhone vs. iLet BP experiments. Subjects were given a visual analog scale measuring 100 mm and asked to draw a line to indicate their level of nausea at timepoints during the study with 100 being the "worst possible nausea" and 0 being "no nausea".'}, {'measure': 'Average Insulin Infusion Site Pain From VAS', 'timeFrame': '8 hours', 'description': 'This applies to the iPhone vs. iLet BP experiments and the infusion set sub-study experiments. Subjects were given a visual analog scale measuring 100 mm and asked to draw a line to indicate their level of pain at timepoints during the study with 100 being the "worst possible pain" and 0 being "no pain".'}, {'measure': 'Difference in Local Erythema and Edema According to the Draize Scale', 'timeFrame': '8 hours', 'description': 'This applies to the iPhone vs. iLet BP experiments and the infusion set sub-study experiments. The draize scale assess erythema, eschar and edema using a score from 0-4, with 4 meaning a worse outcome.'}, {'measure': 'Number of Unscheduled Infusion Set Replacements.', 'timeFrame': '8 hours', 'description': 'This applies to the iPhone vs. iLet BP experiments and the infusion set sub-study experiments.'}, {'measure': 'Number of Unscheduled CGM Sensor Changes.', 'timeFrame': '8 hours', 'description': 'This applies only to the iPhone vs. iLet BP experiments'}, {'measure': 'Insulin Area Under the Curve During the Initial 90 Minute Fasted Period', 'timeFrame': '8 hours', 'description': 'This applies only to the infusion set sub-study'}, {'measure': 'Mean Insulin Levels During the Initial 90 Minute Fasted Period', 'timeFrame': '8 hours', 'description': 'This applies only to the infusion set sub-study'}, {'measure': 'Difference Between Insulin Levels at Baseline and at 90 Minutes', 'timeFrame': '8 hours', 'description': 'This applies only to the infusion set sub-study'}, {'measure': 'Tmax After the Insulin Dose', 'timeFrame': '8 hours', 'description': 'This applies only to the infusion set sub-study'}, {'measure': 'T 1/2 Max After the Insulin Dose', 'timeFrame': '8 hours', 'description': 'This applies only to the infusion set sub-study'}, {'measure': 'C Max After the Insulin Dose', 'timeFrame': '8 hours', 'description': 'This applies only to the infusion set sub-study'}, {'measure': 'AUC in the First 30 Minutes After the Insulin Dose', 'timeFrame': '8 hours', 'description': 'This applies only to the infusion set sub-study'}, {'measure': 'AUC in the First 60 Minutes After the Insulin Dose', 'timeFrame': '8 hours', 'description': 'This applies only to the infusion set sub-study'}, {'measure': 'AUC in the First 90 Minutes After the Insulin Dose', 'timeFrame': '8 hours', 'description': 'This applies only to the infusion set sub-study'}, {'measure': 'Terminal Half Life After the Insulin Dose', 'timeFrame': '8 hours', 'description': 'This applies only to the infusion set sub-study'}, {'measure': 'Difference Between the Fasted PG Value and the PG Value at 90 Minutes', 'timeFrame': 'Baseline Fasted State and 90 Minutes', 'description': 'This applies only to the infusion set sub-study'}, {'measure': 'Difference in the PG Prior to the Meal and Peak Post-prandial Glucose', 'timeFrame': 'Pre-meal PG value and peak PG value during the 3.5 hours following the meal.', 'description': 'This applies only to the infusion set sub-study'}, {'measure': 'PG AUC in the 3.5 Hours Following the Meal', 'timeFrame': '3.5 hours following the meal', 'description': 'This applies only to the infusion set sub-study'}]}, 'oversightModule': {'oversightHasDmc': True, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Bionic Pancreas', 'Insulin', 'Glucagon', 'Continuous Glucose Monitor'], 'conditions': ['Diabetes Mellitus Type 1']}, 'descriptionModule': {'briefSummary': 'This study will compare two different models of a wearable bionic pancreas device (the iPhone-based bionic pancreas vs. the iLet bionic pancreas) in adult participant with type 1 diabetes. Both bionic pancreas devices measure glucose levels every five minutes and then give insulin and/or glucagon automatically to regulate the blood glucose (BG).', 'detailedDescription': 'The iPhone bionic pancreas has been used in earlier studies, during which volunteers used the system for up to 11 days at a time while living their normal lives at home and work. The iLet bionic pancreas has never been tested in humans. In this new study, volunteers will participate in a training visit to learn how both devices work. They will then use the iPhone-based BP for 1 day and the iLet BP for 1 day in random order using Lilly glucagon. They will then use the iLet BP for one additional day using Xeris Xerisol glucagon (a stable formulation of human glucagon).\n\nA custom infusion set is required for this bihormonal system, to prevent future consumers from being able to accidentally swap their insulin and glucagon reservoirs and infusion sets, which could be potentially fatal. Previous experiments have demonstrated flaws in the infusion set design, requiring human experiments to be suspended and modifications to the infusion set be made. We believe the current infusion set has addressed these flaws by incorporating an anti-coring heel and a tri-beveled needle, and the infusion set sub-study is designed to isolate and study the infusion set function before further experiments using the iLet BP are conducted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\niPhone and iLet BP experiments\n\n* Age ≥ 18 years and have had clinical type 1 diabetes for at least one year\n* Diabetes managed using an insulin pump for ≥ 6 months\n* Prescription medication regimen stable for \\> 1 month (except for medications that will not affect the safety of the study and are not expected to affect any outcome of the study, in the judgment of the principal investigator)\n\niLet Infusion Set Sub-Study\n\n* Age ≥ 18 years and have had clinical type 1 diabetes for at least one year\n* Diabetes managed using an insulin pump for ≥ 6 months\n\nExclusion Criteria:\n\niPhone and iLet BP experiments\n\n* Unable to provide informed consent (e.g. impaired cognition or judgment)\n* Unable to safely comply with study procedures and reporting requirements (e.g. impairment of vision or dexterity that prevents safe operation of the bionic pancreas, impaired memory, unable to speak and read English)\n* Current participation in another diabetes-related clinical trial that, in the judgment of the principal investigator, will compromise the results of this study or the safety of the subject\n* Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception\n* Current alcohol abuse (intake averaging \\> 3 drinks daily in last 30 days), use of marijuana within 1 month of enrollment, or other substance abuse (use within the last 6 months of controlled substances other than marijuana without a prescription)\n* Unwilling or unable to refrain on the study days from:acetaminophen in any form, use of marijuana, use of drugs that may dull the sensorium, reduce sensitivity to symptoms of hypoglycemia, or hinder decision making during the period of participation in the study (use of beta blockers will be allowed as long as the dose is stable and the subject does not meet the criteria for hypoglycemia unawareness while taking that stable dose, but use of benzodiazepines or narcotics, even if by prescription, may be excluded according to the judgment of the principal investigator)\n* History of liver disease that is expected to interfere with the anti-hypoglycemia action of glucagon (e.g. liver failure or cirrhosis). Other liver disease (i.e. active hepatitis, steatosis, active biliary disease, any tumor of the liver, hemochromatosis, glycogen storage disease) may exclude the subject if it causes significant compromise to liver function or may do so in an unpredictable fashion.\n* Renal failure on dialysis\n* Personal history of cystic fibrosis, pancreatitis, pancreatic tumor, or any other pancreatic disease besides type 1 diabetes\n* Any known history of coronary artery disease including, but not limited to, history of myocardial infarction, stress test showing ischemia, history of angina, or history of intervention such as coronary artery bypass grafting, percutaneous coronary intervention, or enzymatic lysis of a presumed coronary occlusion)\n* Congestive heart failure (established history of CHF, lower extremity edema, paroxysmal nocturnal dyspnea, or orthopnea)\n* History of TIA or stroke\n* Seizure disorder, history of any non-hypoglycemic seizure within the last two years, or ongoing treatment with anticonvulsants\n* History of hypoglycemic seizures (grand-mal) or coma in the last year\n* History of pheochromocytoma: fractionated metanephrines will be tested in patients with history increasing the risk for a catecholamine secreting tumor: Episodic or treatment refractory (requiring 4 or more medications to achieve normotension) hypertension, Paroxysms of tachycardia, pallor, or headache, Personal or family history of MEN 2A, MEN 2B, neurofibromatosis, or von Hippel-Lindau disease\n* History of adrenal disease or tumor\n* Hypertension with systolic BP ≥160 mm Hg or diastolic BP ≥100 despite treatment\n* Untreated or inadequately treated mental illness (indicators would include symptoms such as psychosis, hallucinations, mania, and any psychiatric hospitalization in the last year), or treatment with anti-psychotic medications that are known to affect glucose regulation.\n* Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to RF interference\n* History of adverse reaction to glucagon (including allergy) besides nausea and vomiting\n* Established history of allergy or severe reaction to adhesive or tape that must be used in the study\n* Use of oral (e.g. thiazolidinediones, biguanides, sulfonylureas, glitinides, DPP-4 inhibitors, SGLT-2 inhibitors) anti-diabetic medications\n* Hemoglobin \\< 12 g/dl\n* Any factors that, in the opinion of the principal investigator would interfere with the safe completion of the study\n\niLet Infusion Set Sub-Study\n\n* Unable to provide informed consent (e.g. impaired cognition or judgment)\n* Unable to safely comply with study procedures and reporting requirements (e.g. impairment of vision or dexterity that prevents safe operation of their insulin pump, impaired memory, unable to speak and read English)\n* Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception\n* Hemoglobin \\< 11 g/dl\n* Unable to establish IV access, or subject reports difficult IV access in the past\n* History of allergy or severe reaction to adhesive or tape that must be used in the study'}, 'identificationModule': {'nctId': 'NCT02701257', 'briefTitle': 'The iLet Introduction Study: A Feasibility Study of the iLet, a Fully Integrated Bihormonal Bionic Pancreas', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'The iLet Introduction Study: A Feasibility Study of the iLet, a Fully Integrated Bihormonal Bionic Pancreas', 'orgStudyIdInfo': {'id': '2015P002773'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'iPhone bionic pancreas - Lilly glucagon', 'description': 'iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.', 'interventionNames': ['Device: iPhone bionic pancreas', 'Drug: Lilly glucagon']}, {'type': 'EXPERIMENTAL', 'label': 'iLet bionic pancreas - Lilly glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.', 'interventionNames': ['Device: iLet bionic pancreas', 'Drug: Lilly glucagon']}, {'type': 'EXPERIMENTAL', 'label': 'iLet bionic pancreas - Xerisol glucagon', 'description': 'iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.', 'interventionNames': ['Device: iLet bionic pancreas', 'Drug: Xeris Xerisol glucagon']}, {'type': 'EXPERIMENTAL', 'label': 'iLet infusion set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.', 'interventionNames': ['Device: iLet infusion set']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Contact Detach infusion set', 'description': 'The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.', 'interventionNames': ['Device: Contact Detach infusion set']}], 'interventions': [{'name': 'iPhone bionic pancreas', 'type': 'DEVICE', 'description': 'An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps', 'armGroupLabels': ['iPhone bionic pancreas - Lilly glucagon']}, {'name': 'iLet bionic pancreas', 'type': 'DEVICE', 'description': 'An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.', 'armGroupLabels': ['iLet bionic pancreas - Lilly glucagon', 'iLet bionic pancreas - Xerisol glucagon']}, {'name': 'Xeris Xerisol glucagon', 'type': 'DRUG', 'otherNames': ['Xeris glucagon'], 'description': 'A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump', 'armGroupLabels': ['iLet bionic pancreas - Xerisol glucagon']}, {'name': 'Lilly glucagon', 'type': 'DRUG', 'otherNames': ['glucagon'], 'description': 'An aqueous formulation of human glucagon with limited stability that must be changed daily', 'armGroupLabels': ['iLet bionic pancreas - Lilly glucagon', 'iPhone bionic pancreas - Lilly glucagon']}, {'name': 'iLet infusion set', 'type': 'DEVICE', 'description': 'The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.', 'armGroupLabels': ['iLet infusion set']}, {'name': 'Contact Detach infusion set', 'type': 'DEVICE', 'description': 'The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.', 'armGroupLabels': ['Contact Detach infusion set']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'MGH Diabetes Research Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Steven J Russell, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'De-identified IPD will be published as online supplemental material to the main paper describing the results, as we have done for all of our previous bionic pancreas studies.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boston University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Steven J. Russell, MD, PhD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}