Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-30 @ 4:47 AM
Study NCT ID:
NCT03565666
Status:
COMPLETED
Last Update Posted:
2019-09-04
First Post:
2018-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Insulin-Only Bionic Pancreas Bridging Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061267', 'term': 'Insulin Aspart'}], 'ancestors': [{'id': 'D061266', 'term': 'Insulin, Short-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'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': 'sjrussell@mgh.harvard.edu', 'phone': '617-726-8722', 'title': 'Dr. Steven J. Russell', 'organization': 'Mass. General Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 2 months for the RCT', 'eventGroups': [{'id': 'EG000', 'title': 'Usual Care Arm', 'description': 'Participants who completed 7 days of managing their diabetes with their usual care (either MDI or insulin pump) during the 3 weeks of the study period 35 participants completed this arm\n\nUsual care: Usual care', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 4, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'iLet With Humalog/Novolog Arm', 'description': 'Participants who completed 7 days of using the iLet with either Novolog or Humalog to manage their diabetes during the 3 weeks of the study period 34 participants completed this arm', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 15, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'iLet Using Fiasp Arm', 'description': 'Participants who completed 7 days of using the iLet with faster acting aspart (Fiasp) to manage their diabetes during the 3 weeks of the study period 35 participants completed this arm', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 16, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Non-serious adverse event', 'notes': 'Elevated ketones \\>1.0 mmol/L (no DKA)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non serious adverse event', 'notes': 'Nausea without vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-serious adverse event', 'notes': 'Hypoglycemia For the test run, data for hypos is collected from RedCap surveys and for RCT data is collected from CGM downloads', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 10, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 19, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 27, 'numAffected': 15}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Serious adverse event', 'notes': 'Severe hypoglycemia defined as hypoglycemia necessitating the aid of a third party for recovery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean CGM Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care Arm', 'description': 'Participants who completed 7 days of managing their diabetes with their usual care (either MDI or insulin pump) during the 3 weeks of the study period 35 participants completed this arm'}, {'id': 'OG001', 'title': 'iLet With Insulin Analogue (Novolog/Humalog) Arm', 'description': 'Participants who completed 7 days of using the iLet with either Novolog or Humalog to manage their diabetes during the 3 weeks of the study period 34 participants completed this arm'}, {'id': 'OG002', 'title': 'iLet Using Fiasp Arm', 'description': 'Participants who completed 7 days of using the iLet with faster acting aspart (Fiasp) to manage their diabetes during the 3 weeks of the study period 35 participants completed this arm'}], 'classes': [{'categories': [{'measurements': [{'value': '144.3', 'spread': '9.5', 'groupId': 'OG000'}, {'value': '162', 'spread': '26', 'groupId': 'OG001'}, {'value': '155', 'spread': '12', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 3-7 for the RCT Period', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of Time Where Glucose is Less Than 54 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care Arm', 'description': 'Participants who completed 7 days of managing their diabetes with their usual care (either MDI or insulin pump) during the 3 weeks of the study period 35 participants completed this arm'}, {'id': 'OG001', 'title': 'iLet With Insulin Analogue (Novolog/Humalog) Arm', 'description': 'Participants who completed 7 days of using the iLet with either Novolog or Humalog to manage their diabetes during the 3 weeks of the study period 34 participants completed this arm'}, {'id': 'OG002', 'title': 'iLet Using Fiasp Arm', 'description': 'Participants who completed 7 days of using the iLet with faster acting aspart (Fiasp) to manage their diabetes during the 3 weeks of the study period 35 participants completed this arm'}], 'classes': [{'categories': [{'measurements': [{'value': '0.58', 'groupId': 'OG000', 'lowerLimit': '0.39', 'upperLimit': '0.93'}, {'value': '0.53', 'groupId': 'OG001', 'lowerLimit': '0.18', 'upperLimit': '0.98'}, {'value': '0.56', 'groupId': 'OG002', 'lowerLimit': '0.17', 'upperLimit': '1.12'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 3-7 for the RCT Period', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Episodes of Severe Hypoglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care Arm', 'description': 'Participants who completed 7 days of managing their diabetes with their usual care (either MDI or insulin pump) during the 3 weeks of the study period 35 participants completed this arm'}, {'id': 'OG001', 'title': 'iLet With Insulin Analogue (Novolog/Humalog) Arm', 'description': 'Participants who completed 7 days of using the iLet with either Novolog or Humalog to manage their diabetes during the 3 weeks of the study period 34 participants completed this arm'}, {'id': 'OG002', 'title': 'iLet Using Fiasp Arm', 'description': 'Participants who completed 7 days of using the iLet with faster acting aspart (Fiasp) to manage their diabetes during the 3 weeks of the study period 35 participants completed this arm'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 3-7 for the RCT Period', 'description': 'Pre-specified to report the total number of episodes summed across all participants', 'unitOfMeasure': 'number of episodes', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Episodes of Diabetic Ketoacidosis (DKA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care Arm', 'description': 'Participants who completed 7 days of managing their diabetes with their usual care (either MDI or insulin pump) during the 3 weeks of the study period 35 participants completed this arm'}, {'id': 'OG001', 'title': 'iLet With Insulin Analogue (Novolog/Humalog) Arm', 'description': 'Participants who completed 7 days of using the iLet with either Novolog or Humalog to manage their diabetes during the 3 weeks of the study period 34 participants completed this arm'}, {'id': 'OG002', 'title': 'iLet Using Fiasp Arm', 'description': 'Participants who completed 7 days of using the iLet with faster acting aspart (Fiasp) to manage their diabetes during the 3 weeks of the study period 35 participants completed this arm'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 3-7 for the RCT Period', 'description': 'pre-specified to report the total number of episodes summed across all participants', 'unitOfMeasure': 'number of episodes', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Time Where Glucose is Less Than 70 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care Arm', 'description': 'Participants who completed 7 days of managing their diabetes with their usual care (either MDI or insulin pump) during the 3 weeks of the study period 35 participants completed this arm'}, {'id': 'OG001', 'title': 'iLet Using Humalog/Novolog Arm', 'description': 'Participants who completed 7 days of using the iLet with either Novolog or Humalog to manage their diabetes during the 3 weeks of the study period 34 participants completed this arm'}, {'id': 'OG002', 'title': 'iLet Using Fiasp Arm', 'description': 'Participants who completed 7 days of using the iLet with faster acting aspart (Fiasp) to manage their diabetes during the 3 weeks of the study period 35 participants completed this arm'}], 'classes': [{'categories': [{'measurements': [{'value': '5.09', 'groupId': 'OG000', 'lowerLimit': '3.73', 'upperLimit': '5.5'}, {'value': '3.2', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '5.2'}, {'value': '2.7', 'groupId': 'OG002', 'lowerLimit': '1.5', 'upperLimit': '3.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 3-7 for the RCT Period', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Time in the Glucose Target Range of 70-180 mg/dl', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care Arm', 'description': 'Participants who completed 7 days of managing their diabetes with their usual care (either MDI or insulin pump) during the 3 weeks of the study period 35 participants completed this arm'}, {'id': 'OG001', 'title': 'iLet Using Humalog/Novolog Arm', 'description': 'Participants who completed 7 days of using the iLet with either Novolog or Humalog to manage their diabetes during the 3 weeks of the study period 34 participants completed this arm'}, {'id': 'OG002', 'title': 'iLet Using Fiasp Arm', 'description': 'Participants who completed 7 days of using the iLet with faster acting aspart (Fiasp) to manage their diabetes during the 3 weeks of the study period 35 participants completed this arm'}], 'classes': [{'categories': [{'measurements': [{'value': '73.3', 'spread': '7.35', 'groupId': 'OG000'}, {'value': '62.2', 'spread': '16.2', 'groupId': 'OG001'}, {'value': '69.2', 'spread': '9.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 3-7 for the RCT Period', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Time Where Glucose is Greater Than 180 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care Arm', 'description': 'Participants who completed 7 days of managing their diabetes with their usual care (either MDI or insulin pump) during the 3 weeks of the study period 35 participants completed this arm'}, {'id': 'OG001', 'title': 'iLet Using Humalog/Novolog Arm', 'description': 'Participants who completed 7 days of using the iLet with either Novolog or Humalog to manage their diabetes during the 3 weeks of the study period 34 participants completed this arm'}, {'id': 'OG002', 'title': 'iLet Using Fiasp Arm', 'description': 'Participants who completed 7 days of using the iLet with faster acting aspart (Fiasp) to manage their diabetes during the 3 weeks of the study period 35 participants completed this arm'}], 'classes': [{'categories': [{'measurements': [{'value': '21.8', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '34.4', 'spread': '16.9', 'groupId': 'OG001'}, {'value': '27.96', 'spread': '8.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 3-7 for the RCT Period', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Time Where Glucose is Less Than 60 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care Arm', 'description': 'Participants who completed 7 days of managing their diabetes with their usual care (either MDI or insulin pump) during the 3 weeks of the study period 35 participants completed this arm'}, {'id': 'OG001', 'title': 'iLet Using Humalog/Novolog Arm', 'description': 'Participants who completed 7 days of using the iLet with either Novolog or Humalog to manage their diabetes during the 3 weeks of the study period 34 participants completed this arm'}, {'id': 'OG002', 'title': 'iLet Using Fiasp Arm', 'description': 'Participants who completed 7 days of using the iLet with faster acting aspart (Fiasp) to manage their diabetes during the 3 weeks of the study period 35 participants completed this arm'}], 'classes': [{'categories': [{'measurements': [{'value': '1.67', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '1.23', 'groupId': 'OG001'}, {'value': '1.19', 'spread': '0.93', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 3-7 for the RCT Period', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Time Where Glucose is Greater Than 250 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care Arm', 'description': 'Participants who completed 7 days of managing their diabetes with their usual care (either MDI or insulin pump) during the 3 weeks of the study period 35 participants completed this arm'}, {'id': 'OG001', 'title': 'iLet Using Humalog/Novolog Arm', 'description': 'Participants who completed 7 days of using the iLet with either Novolog or Humalog to manage their diabetes during the 3 weeks of the study period 34 participants completed this arm'}, {'id': 'OG002', 'title': 'iLet Using Fiasp Arm', 'description': 'Participants who completed 7 days of using the iLet with faster acting aspart (Fiasp) to manage their diabetes during the 3 weeks of the study period 35 participants completed this arm'}], 'classes': [{'categories': [{'measurements': [{'value': '3.64', 'spread': '3.03', 'groupId': 'OG000'}, {'value': '10.42', 'spread': '10.43', 'groupId': 'OG001'}, {'value': '7.73', 'spread': '4.99', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 3-7 for the RCT Period', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage Time in the Glucose Target Range of 70-120mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care Arm', 'description': 'Participants who completed 7 days of managing their diabetes with their usual care (either MDI or insulin pump) during the 3 weeks of the study period 35 participants completed this arm'}, {'id': 'OG001', 'title': 'iLet Using Humalog/Novolog Arm', 'description': 'Participants who completed 7 days of using the iLet with either Novolog or Humalog to manage their diabetes during the 3 weeks of the study period 34 participants completed this arm'}, {'id': 'OG002', 'title': 'iLet Using Fiasp Arm', 'description': 'Participants who completed 7 days of using the iLet with faster acting aspart (Fiasp) to manage their diabetes during the 3 weeks of the study period 35 participants completed this arm'}], 'classes': [{'categories': [{'measurements': [{'value': '30.65', 'spread': '4.17', 'groupId': 'OG000'}, {'value': '25.65', 'spread': '12.36', 'groupId': 'OG001'}, {'value': '28.24', 'spread': '7.98', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 3-7 for the RCT Period', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Absolute Relative Difference Between Dexcom G5 CGM and Contour Next One Glucose Meter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RCT Period Days 1-7', 'description': '36 adult patients with type 1 diabetes will complete 3 arms in a random-order crossover fashion. Half of the subjects (n=18) will wear the Dexcom G5 continuous glucose monitor (CGM) and the other half will wear a Senseonics Eversense CGM.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.8', 'spread': '8.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 3-7 for the RCT Period', 'description': 'The MARD is calculated as the mean value of individual absolute relative differences (ARD). The ARD is calculated as follows: 100\\*(CGM-reference glucose)/reference glucose', 'unitOfMeasure': 'MARD (CGMG-meter glucose)/meter glucose)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Absolute Relative Difference Between Senseonics Eversense CGM and Contour Next One Glucose Meter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Days 1-7 of RCT', 'description': '36 adult patients with type 1 diabetes will complete 3 arms in a random-order crossover fashion. Half of the subjects (n=18) will wear the Dexcom G5 continuous glucose monitor (CGM) and the other half will wear a Senseonics Eversense CGM.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.3', 'spread': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1-7 of the Adult RCT period', 'description': 'The MARD is calculated as the mean value of individual absolute relative differences (ARD). The ARD is calculated as follows: 100\\*(CGM-reference glucose)/reference glucose', 'unitOfMeasure': 'MARD: Mean of all [(CGMG - PG)/PG]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Usual Care Then Either iLet/Novolog/Humalog or iLet/Fiasp', 'description': 'Participants first started the usual care arm (managing their diabetes with either multiple daily injections or insulin pump) for 7 days, then switched to either the insulin-only iLet using Novolog or Humalog for 7 days, or the insulin-only iLet using Fiasp for 7 days. No washout period was required between arms'}, {'id': 'FG001', 'title': 'iLet/Novolog/Humalog Then Either iLet/Fiasp or Usual Care', 'description': 'Participants first started using the insulin-only iLet with either Novolog or Humalog for 7 days then switched to either the usual care arm (managing their diabetes with multiple daily injections or insulin pump) for 7 days, or the insulin-only iLet arm using Fiasp for 7 days. No washout period was required between arms.'}, {'id': 'FG002', 'title': 'iLet/Fiasp Then Either iLet With Novolog/Humalog or Usual Care', 'description': 'Participants first started the insulin-only iLet using Fiasp for 7 days, then switched to either the insulin-only iLet arm using Novolog or Humalog for 7 days or the usual care arm, (managing their diabetes with either multiple daily injections or insulin pump) for 7 days. No washout period was required between arms'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '18 participants were recruited at MGH and 18 participants at Stanford', 'preAssignmentDetails': 'This study consisted of a test-run period followed by an RCT'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': '36 adult patients with type 1 diabetes will complete 3 arms in a random-order crossover fashion. Participants in the usual care arm (UC) will manage their diabetes with either multiple daily injections or continuous subcutaneous insulin infusion (pump therapy). All subjects will wear Dexcom G5 continuous glucose monitor (CGM) and half of all subjects will also wear a senseonics CGM.\n\nEach arm is 7 days, no washout between arms'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '1 participant was not analysed as they discontinued the study after 1 day and did not meet the criteria for their results to be included in the analyses (according to the protocol)'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '41', 'spread': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White non-hispanic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}, {'title': 'Bklack/African-American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'American Indian/Alaskan Native', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '1 participant was not analysed as they discontinued the study after 1 day and did not meet the criteria for their results to be included in the analyses (according to the protocol)'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-26', 'size': 1632015, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-03-12T13:14', 'hasProtocol': True}, {'date': '2018-09-21', 'size': 362805, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-07-16T11:38', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-02', 'studyFirstSubmitDate': '2018-05-29', 'resultsFirstSubmitDate': '2019-04-15', 'studyFirstSubmitQcDate': '2018-06-11', 'lastUpdatePostDateStruct': {'date': '2019-09-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-02', 'studyFirstPostDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-09-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Episodes of Severe Hypoglycemia', 'timeFrame': 'Days 3-7 for the RCT Period', 'description': 'Pre-specified to report the total number of episodes summed across all participants'}, {'measure': 'Episodes of Diabetic Ketoacidosis (DKA)', 'timeFrame': 'Days 3-7 for the RCT Period', 'description': 'pre-specified to report the total number of episodes summed across all participants'}, {'measure': 'Percentage of Time Where Glucose is Less Than 70 mg/dL', 'timeFrame': 'Days 3-7 for the RCT Period'}, {'measure': 'Percentage of Time in the Glucose Target Range of 70-180 mg/dl', 'timeFrame': 'Days 3-7 for the RCT Period'}, {'measure': 'Percentage of Time Where Glucose is Greater Than 180 mg/dL', 'timeFrame': 'Days 3-7 for the RCT Period'}, {'measure': 'Percentage of Time Where Glucose is Less Than 60 mg/dL', 'timeFrame': 'Days 3-7 for the RCT Period'}, {'measure': 'Percentage of Time Where Glucose is Greater Than 250 mg/dL', 'timeFrame': 'Days 3-7 for the RCT Period'}, {'measure': 'Percentage Time in the Glucose Target Range of 70-120mg/dL', 'timeFrame': 'Days 3-7 for the RCT Period'}, {'measure': 'Mean Absolute Relative Difference Between Dexcom G5 CGM and Contour Next One Glucose Meter', 'timeFrame': 'Days 3-7 for the RCT Period', 'description': 'The MARD is calculated as the mean value of individual absolute relative differences (ARD). The ARD is calculated as follows: 100\\*(CGM-reference glucose)/reference glucose'}, {'measure': 'Mean Absolute Relative Difference Between Senseonics Eversense CGM and Contour Next One Glucose Meter', 'timeFrame': 'Days 1-7 of the Adult RCT period', 'description': 'The MARD is calculated as the mean value of individual absolute relative differences (ARD). The ARD is calculated as follows: 100\\*(CGM-reference glucose)/reference glucose'}], 'primaryOutcomes': [{'measure': 'Mean CGM Glucose', 'timeFrame': 'Days 3-7 for the RCT Period'}, {'measure': 'Percentage of Time Where Glucose is Less Than 54 mg/dL', 'timeFrame': 'Days 3-7 for the RCT Period'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['bionic pancreas', 'closed loop', 'insulin', 'continuous glucose monitor'], 'conditions': ['Type1 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The iLet is a closed-loop delivery system that can be used in insulin-only, bihormonal, or glucagon-only configurations. Previous studies have utilized a phone-based bionic pancreas. The iLet consists of a touchscreen-enabled, menu-driven user interface and an onboard microprocessor that provides a comprehensive and standalone platform, which allows the iLet to operate independently of smartphones or other devices and without the need for internet support during routine operation.\n\nThis is a multicenter study of adult participants with type 1 diabetes, who will manage their diabetes with the iLet bionic pancreas compared to usual care.', 'detailedDescription': "This study will serve as a transitional study, bridging to larger and longer outpatient pivotal studies using the insulin-only configuration of the bionic pancreas.\n\nThe Adult RCT Period will consist of a multi-center, three-period, random-order, cross-over, feasibility study in 36 adult participants ≥ 18 years old with T1D. Insulin therapy for each participant will be administered (i) using the iLet in the insulin-only configuration and the insulin analog that they use for their usual care (either Humalog or Novolog) for 7 days, (ii) in another period using the iLet in the insulin-only configuration with faster insulin aspart (Fiasp) for 7 days (iii) in a third period using the participant's own usual care (UC) for 7 days. All three experimental periods will be followed by round-the-clock, remote, telemetric monitoring for hyperglycemia (\\> 300 mg/dl for ≥ 90 minutes) and hypoglycemia (\\< 50 mg/dl for ≥ 15 minutes). Half the subjects enrolled were expected to manage their diabetes with MDI and the other half with insulin pumps in their UC. An implantable Eversense CGM will also be placed in half the study participants for a CGM comparison."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Clinical diagnosis of type 1 diabetes for at least one year and using insulin for at least 1 year\n2. Diabetes managed using an insulin pump for ≥ 3 months or with multiple daily injections (approximately 1/2 of participants should use a pump and approximately 1/2 should use MDI)\n3. Age ≥18 years;\n\n • There is no upper age limit in the Adult RCT Period (instead the exclusion criteria are used to restrict the participants to those healthy enough to participate in the trial)\n4. HbA1c level \\<11.0%\n\n • A point of care or local lab measurement is used to assess eligibility for screening.\n5. At least 3 SMBG meter tests daily on average or use of a CGM and 2 or more SMBG meter tests daily on average by history\n6. For females, not currently known to be pregnant\n\n • If female, sexually active, and at risk for pregnancy, must agree to use a highly effective form of contraception to prevent pregnancy while a participant in the study. A negative urine pregnancy test will be required for all women who are post-menarche and pre-menopause who are not surgically sterile. Participants who become pregnant will be discontinued from the study.\n7. An understanding of and willingness to follow the protocol and sign the informed consent and assent where applicable\n\nExclusion Criteria:\n\n-The presence of any of the following is an exclusion for the study:\n\n1. Unable to provide informed consent (e.g. impaired cognition or judgment)\n2. Unable to safely comply with study procedures and reporting requirements (e.g. impairment of vision or dexterity that prevents safe operation of the BP, impaired memory)\n3. Unable to speak and read English\n4. Currently using for the first time a real-time CGM for \\< 1 month (Individuals who have been using CGM for 1 or more months are eligible)\n5. Current use of non-FDA approved closed-loop or hybrid closed-loop insulin delivery system\n6. Current use of insulin glulisine (Apidra) as part of usual diabetes home regimen\n7. Current off-label use of faster-acting insulin aspart (Fiasp) in CSII therapy as part of usual diabetes home regimen\n8. 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 participant\n9. Pregnant (positive urine HCG), breast feeding, plan to become pregnant in the next 12 months, or sexually active and at risk for pregnancy without use of contraception\n10. Current alcohol abuse (intake averaging \\>4 drinks daily in last 30 days) or other substance abuse (use within the last 3 months of controlled substances other than marijuana without a prescription)\n11. Unwilling or unable or to avoid 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 benzodiazepines or narcotics, even if by prescription, may be excluded according to the judgment of the principal investigator)\n12. Stage 4 renal failure (eGFR \\<30) or Stage 5 renal failure on dialysis (hemodialysis or peritoneal dialysis)\n13. History of cystic fibrosis, pancreatitis, or other pancreatic disease, including pancreatic tumor or insulinoma, or history of complete pancreatectomy\n14. Coronary artery disease that is not stable with medical management, including unstable angina, angina that prevents moderate exercise (e.g. exercise of intensity up to 6 METS) despite medical management, or within the last 12 months before screening a history of myocardial infarction, percutaneous coronary intervention, enzymatic lysis of a presumed coronary occlusion, or coronary artery bypass grafting\n15. Abnormal EKG consistent with increased risk of malignant arrhythmia including, but not limited to, evidence of active ischemia, proximal LAD critical stenosis (Wellen's sign), or prolonged QT interval (\\> 440 ms). Other EKG findings, including stable Q waves, are not grounds for exclusion as long as the participant is not excluded according to other criteria. A reassuring evaluation by a cardiologist after an abnormal EKG finding may allow participation.\n\n • EKG is only required for participants ≥50 years old or with diabetes duration ≥20 years\n16. For participants \\< 50 years of age and \\< 20 years since diagnosis: History of prolonged QT interval, malignant arrhythmia, or congenital heart disease\n17. Congestive heart failure with New York Heart Association (NYHA) Functional Classification III or IV\n18. History of TIA or stroke in the last 12 months\n19. Recent history of diabetic ketoacidosis (DKA) or severe hypoglycemia in the last 6 months. Severe hypoglycemia is defined as an event that required assistance of another person due to altered consciousness, and required another person to actively administer carbohydrate, glucagon, or other resuscitative actions. This means that the participant was impaired cognitively to the point that he/she was unable to treat himself/herself, was unable to verbalize his/ her needs, was incoherent, disoriented, and/or combative, or experienced seizure or coma.\n20. History of more than 1 episode of DKA requiring hospitalization in the last 2 years\n21. History of more than 1 episode of severe hypoglycemia in the last year.\n22. 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.\n23. Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to RF interference\n24. Unable or unwilling to completely avoid acetaminophen for duration of study\n25. Established history of allergy or severe reaction to adhesive or tape that must be used in the study\n26. History of eating disorder within the last 2 years, such as anorexia, bulimia, or diabulemia or omission of insulin to manipulate weight\n27. Current or planned use of SGLT2 inhibitors (prior use more than 3 months prior to enrollment is acceptable; SGLT2 inhibitors should not be initiated during the trial)\n28. If using GLP1, pramlintide, or metformin must be on a stable dose for 3 months prior to enrollment (these agents should not be initiated during the trial)\n29. Required use of 2 or more steroid bursts in the 6 months prior to the trial\n30. History of intentional, inappropriate administration of insulin leading to severe hypoglycemia requiring treatment\n31. Any factors that, in the opinion of the site principal investigator or clinical protocol chair, would interfere with the safe completion of the study, including medical conditions that may require hospitalization during the trial"}, 'identificationModule': {'nctId': 'NCT03565666', 'briefTitle': 'The Insulin-Only Bionic Pancreas Bridging Study', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'The Insulin-Only Bionic Pancreas Bridging Study', 'orgStudyIdInfo': {'id': '2018P000853'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Adult RCT: Usual care', 'description': "Participants randomized to usual care first started the usual care arm (UC) managing their diabetes with either multiple daily injections or continuous subcutaneous insulin infusion (pump therapy) for 7 days. All subjects wore a Dexcom G5 continuous glucose monitor (CGM) and half of all subjects also were a senseonics CGM. The usual care period was followed by the other 2 arms according to each subject's randomization schedule", 'interventionNames': ['Other: Usual care']}, {'type': 'EXPERIMENTAL', 'label': 'Adult RCT: closed-loop control with iLet Humalog or Novolog', 'description': "Participants randomized to the iLet with humalog/novolog first started the insulin-only iLet arm using the insulin analog that they use for their usual care (either Humalog or Novolog). All subjects wore a Dexcom G5 CGM and half of all subjects also wore a Senseonics Eversense CGM. The iLet period was followed by the other 2 arms according to each subject's randomization schedule", 'interventionNames': ['Device: iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog']}, {'type': 'EXPERIMENTAL', 'label': 'Adult RCT: closed-loop control with iLet using Fiasp', 'description': "Participants randomized to the iLet with Fiasp first started the insulin-only iLet arm using faster insulin aspart (Fiasp) in PumpCart, where the pharmacokinetic (PK) parameter for tmax used by the insulin-dosing algorithm was set to the same value as is used for Humalog and Novolog (65 minutes). All subjects wore a Dexcom G5 CGM and half of all subjects also wore a Senseonics Eversense CGM. The iLet period was followed by the other 2 arms according to each subject's randomization schedule", 'interventionNames': ['Drug: iLet Bionic Pancreas insulin-only configuration with Fiasp']}], 'interventions': [{'name': 'iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog', 'type': 'DEVICE', 'description': 'iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog', 'armGroupLabels': ['Adult RCT: closed-loop control with iLet Humalog or Novolog']}, {'name': 'iLet Bionic Pancreas insulin-only configuration with Fiasp', 'type': 'DRUG', 'description': 'iLet Bionic Pancreas insulin-only configuration with Fiasp (faster insulin aspart)', 'armGroupLabels': ['Adult RCT: closed-loop control with iLet using Fiasp']}, {'name': 'Usual care', 'type': 'OTHER', 'description': 'Usual care', 'armGroupLabels': ['Adult RCT: Usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Barbara Davis Center for Childhood Diabetes', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': "Nemours Children's Specialty Care", 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}]}, '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'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Study Director', 'investigatorFullName': 'Steven J. Russell, MD, PhD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}