Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-29 @ 10:07 AM
Study NCT ID:
NCT01170208
Status:
COMPLETED
Last Update Posted:
2020-01-27
First Post:
2010-07-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Insulin Dosage Software Program for People With Type 1 and Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'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': 'D006946', 'term': 'Hyperinsulinism'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'richard.bergenstal@parknicollet.com', 'phone': '952-993-3796', 'title': 'Dr. Richard Bergenstal', 'organization': 'International Diabetes Center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Study was limited by lack of a control group.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Group I', 'description': 'Type 1 diabetes treated with basal-bolus insulin therapy, incorporating carbohydrate-counting', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group II', 'description': 'Type 2 diabetes treated with basalbolus therapy', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Group III', 'description': 'Type 2 diabetes treated with biphasic insulin.', 'otherNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Weekly Mean Blood Glucose From Week 4 to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I', 'description': 'Type 1 diabetes treated with basal-bolus insulin the'}, {'id': 'OG001', 'title': 'Group II', 'description': 'Type 2 diabetes treated with basal bolus therapy'}, {'id': 'OG002', 'title': 'Group III', 'description': 'Type 2 diabetes treated with biphasic insulin'}], 'classes': [{'categories': [{'measurements': [{'value': '4.6', 'spread': '29.3', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '51.0', 'groupId': 'OG001'}, {'value': '29.5', 'spread': '17.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Twelve week period from week 4 to week 16', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol'}, {'type': 'SECONDARY', 'title': 'Reduction in HbA1c.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I', 'description': 'Type 1 diabetes treated with basal-bolus insulin therapy, incorporating carbohydrate-counting'}, {'id': 'OG001', 'title': 'Group II', 'description': 'Type 2 diabetes treated with basalbolus therapy'}, {'id': 'OG002', 'title': 'Group III', 'description': 'Type 2 diabetes treated with biphasic insulin.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '1.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Twelve week period from week 4 to week 16', 'unitOfMeasure': 'percentage of A1c', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Reduction in Fructosamine.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I', 'description': 'Type 1 diabetes treated with basal-bolus insulin the'}, {'id': 'OG001', 'title': 'Group II', 'description': 'Type 2 diabetes treated with basal bolus therapy'}, {'id': 'OG002', 'title': 'Group III', 'description': 'Type 2 diabetes treated with biphasic insulin'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.2', 'spread': '29.2', 'groupId': 'OG000'}, {'value': '10.2', 'spread': '32.2', 'groupId': 'OG001'}, {'value': '37.0', 'spread': '20.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 week period from Week 4 to Week 16', 'unitOfMeasure': 'µM', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Severe or Serious Hypoglycemia.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I', 'description': 'Type 1 diabetes treated with basal-bolus insulin the'}, {'id': 'OG001', 'title': 'Group II', 'description': 'Type 2 diabetes treated with basal bolus therapy'}, {'id': 'OG002', 'title': 'Group III', 'description': 'Type 2 diabetes treated with biphasic insulin'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'January 2011', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group I', 'description': 'Type 1 diabetes treated with basal-bolus insulin therapy, incorporating carbohydrate-counting'}, {'id': 'FG001', 'title': 'Group II', 'description': 'Type 2 diabetes treated with basalbolus therapy'}, {'id': 'FG002', 'title': 'Group III', 'description': 'Type 2 diabetes treated with biphasic insulin.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'July 2010 to October 2010. Location: Medical Clinic'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Group I', 'description': 'Type 1 diabetes treated with basal-bolus insulin therapy, incorporating carbohydrate-counting'}, {'id': 'BG001', 'title': 'Group II', 'description': 'Type 2 diabetes treated with basalbolus therapy'}, {'id': 'BG002', 'title': 'Group III', 'description': 'Type 2 diabetes treated with biphasic insulin.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44', 'spread': '12', 'groupId': 'BG000'}, {'value': '60', 'spread': '7', 'groupId': 'BG001'}, {'value': '55', 'spread': '7', 'groupId': 'BG002'}, {'value': '52', 'spread': '12', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weekly Mean Blood Glucose', 'classes': [{'categories': [{'measurements': [{'value': '176.9', 'spread': '28.3', 'groupId': 'BG000'}, {'value': '164.9', 'spread': '37.6', 'groupId': 'BG001'}, {'value': '190.8', 'spread': '47.0', 'groupId': 'BG002'}, {'value': '172.4', 'spread': '35.0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Week 4 baseline weekly mean blood glucose', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HbA1c', 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'spread': '0.6', 'groupId': 'BG000'}, {'value': '8.3', 'spread': '0.8', 'groupId': 'BG001'}, {'value': '9.1', 'spread': '1.5', 'groupId': 'BG002'}, {'value': '8.4', 'spread': '0.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fructosamine', 'classes': [{'categories': [{'measurements': [{'value': '349', 'spread': '46', 'groupId': 'BG000'}, {'value': '273', 'spread': '30', 'groupId': 'BG001'}, {'value': '270', 'spread': '33', 'groupId': 'BG002'}, {'value': '303', 'spread': '53', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'µM', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-16', 'studyFirstSubmitDate': '2010-07-22', 'resultsFirstSubmitDate': '2013-09-05', 'studyFirstSubmitQcDate': '2010-07-26', 'lastUpdatePostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-11-14', 'studyFirstPostDateStruct': {'date': '2010-07-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Weekly Mean Blood Glucose From Week 4 to Week 16', 'timeFrame': 'Twelve week period from week 4 to week 16'}], 'secondaryOutcomes': [{'measure': 'Reduction in HbA1c.', 'timeFrame': 'Twelve week period from week 4 to week 16'}, {'measure': 'Reduction in Fructosamine.', 'timeFrame': '12 week period from Week 4 to Week 16'}, {'measure': 'Incidence of Severe or Serious Hypoglycemia.', 'timeFrame': 'January 2011'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['insulin', 'dosage software'], 'conditions': ['Diabetes', 'Insulin']}, 'referencesModule': {'references': [{'pmid': '8366922', 'type': 'BACKGROUND', 'citation': 'Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.'}, {'pmid': '15983302', 'type': 'BACKGROUND', 'citation': 'Herman WH, Ilag LL, Johnson SL, Martin CL, Sinding J, Al Harthi A, Plunkett CD, LaPorte FB, Burke R, Brown MB, Halter JB, Raskin P. A clinical trial of continuous subcutaneous insulin infusion versus multiple daily injections in older adults with type 2 diabetes. Diabetes Care. 2005 Jul;28(7):1568-73. doi: 10.2337/diacare.28.7.1568.'}, {'pmid': '18364392', 'type': 'BACKGROUND', 'citation': 'Bergenstal RM, Johnson M, Powers MA, Wynne A, Vlajnic A, Hollander P, Rendell M. Adjust to target in type 2 diabetes: comparison of a simple algorithm with carbohydrate counting for adjustment of mealtime insulin glulisine. Diabetes Care. 2008 Jul;31(7):1305-10. doi: 10.2337/dc07-2137. Epub 2008 Mar 25.'}, {'pmid': '22568777', 'type': 'DERIVED', 'citation': 'Bergenstal RM, Bashan E, McShane M, Johnson M, Hodish I. Can a tool that automates insulin titration be a key to diabetes management? Diabetes Technol Ther. 2012 Aug;14(8):675-82. doi: 10.1089/dia.2011.0303. Epub 2012 May 8.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/22568777', 'label': 'Publication'}]}, 'descriptionModule': {'briefSummary': "The purpose of the study is to determine the effectiveness and safety of the computer software program in providing insulin dosage recommendations. Participation in the study for 60 research subjects will last for 16-weeks and includes 3-4 clinic visits and a series of weekly telephone calls from the study team (minimum of 12 calls). Participants will be provided with weekly Study Log Sheets to record their daily blood glucose readings, insulin doses, grams of carbohydrate eaten at each meal (if they have type-1 diabetes) and any changes in their health (e.g., hypoglycemic episodes, illnesses). Participants will fax or drop off a copy of the Study Log Sheet. This information will be entered by the IDC study team into the computer software program. The IDC study team will review the information from the software and, based on the IDC's study team approval, any insulin dose changes will be communicated back to the patient by phone or fax.", 'detailedDescription': "Hygieia, Inc. is developing a device intended for use by insulin-requiring patients with diabetes. It will be a pocket-sized, hand-held device, combining a glucose meter with software that analyzes blood glucose levels recorded in the device's memory, and periodically recommends modifications in insulin dosage. The already developed software algorithms are based on the way an endocrinologist evaluates and frequently adjusts insulin dosage in a patient with diabetes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* GROUP I\n* Have been clinically diagnosed with type-1 diabetes for at least 1-year\n* Have an HgbA1c of 7.4% or higher\n* Treated with short-acting insulin analog (i.e. HumaLog® Lispro, NovoLog® Aspart, Apidra® Glulisine) before each meal and only one injection of long-acting insulin analog Lantus® (Glargine), per day. Subjects must typically eat 3 meals per day. The total daily combined dose of the long-acting and short-acting insulin analogs must be 25 units or more. Patient must have been using the same insulin regimen for the previous 3-months\n* Is currently using an insulin/carbohydrate ratio to decide how much short-acting insulin to take before meals and must be able to use the gram versus choice method of carbohydrate counting.\n* GROUP II\n* Have been clinically diagnosed with type-2 diabetes for at least 1-year\n* Have an HgbA1c of 7.4% or higher\n* Treated with short-acting insulin analog (i.e. HumaLog® Lispro, NovoLog® Aspart, Apidra® Glulisine) before each meal and only one injection of long-acting insulin analog Lantus® (Glargine) per day and. Subjects must typically eat 3 meals per day. The total daily combined dose of the long-acting and short-acting insulin analogs must be 25 units or more. Patient must have been using the same insulin regimen for the previous 3-months\n* May be using other diabetes agent(s) at a stable dose for the last 3-months.\n* GROUP III\n* Have been clinically diagnosed with type-2 diabetes for at least 1-year\n* Have an HgbA1c of 7.8% or higher\n* Take twice daily biphasic Insulin (e.g. HumaLog® Mix 75/25, NovoLog® Mix 70/30) or premixed insulin (i.e. Humulin® 70/30, Novolin® 70/30, NPH/Regular insulin 70/30) with a total daily insulin dose of 25 units and have been using the same insulin regimen for the past 3-months\n* May be using other diabetes agent(s) at a stable dose for the last 3-months.\n\nExclusion Criteria:\n\n* Have a history of greater than 2 episodes of severe hypoglycemia in the past year, or have hypoglycemic unawareness when glucose levels are less than or equal to 50 mg/dl\n* Have a significant physical, psychological, or cognitive impairment that would prohibit adherence to the protocol\n* Have any severe cardiovascular disease including a history of congestive heart failure (New York Heart Association \\[NYHA\\] 3 or 4), unstable angina, myocardial infarction or stroke that occurred within the 6-months preceding enrollment\n* Have known active anemia with a hemotocrit less than 25% in women or 30% in men\n* Have known history of renal disease (e.g., serum creatinine level \\>2.0 mg/dl or eGFR \\< 30 ml/min)\n* Have active cancer or cancer in the past 2-years (except non-melanoma skin cancer\n* Have history of significant liver disease including cirrhosis or elevated liver enzymes (e.g., AST and ALT greater than 3 times the upper limit of normal values)\n* Have a body mass index (BMI) \\> 45 kg/m2; and/or\n* Are pregnant, plan to become pregnant during the study period, or are breastfeeding.'}, 'identificationModule': {'nctId': 'NCT01170208', 'briefTitle': 'Insulin Dosage Software Program for People With Type 1 and Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'HealthPartners Institute'}, 'officialTitle': 'Open-Label, Uncontrolled, Single-Arm, Single-Center, 16-Week Study Assessing Efficacy and Safety of Frequently Modified Insulin Therapy Using Dosage Recommending Device Software in 3-Groups of Subjects With Diabetes', 'orgStudyIdInfo': {'id': '03985-10-A'}, 'secondaryIdInfos': [{'id': 'R41DK085974', 'link': 'https://reporter.nih.gov/quickSearch/R41DK085974', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Group I', 'description': 'Type 1 diabetes treated with basal-bolus insulin therapy, incorporating carbohydrate-counting and insulin dose software.', 'interventionNames': ['Device: insulin dose software']}, {'type': 'OTHER', 'label': 'Group II', 'description': 'Type 2 diabetes treated with basal-bolustherapy and insulin dose software.', 'interventionNames': ['Device: insulin dose software']}, {'type': 'OTHER', 'label': 'Group III', 'description': 'Type 2 diabetes treated with biphasic insulin and insulin dose software.', 'interventionNames': ['Device: insulin dose software']}], 'interventions': [{'name': 'insulin dose software', 'type': 'DEVICE', 'otherNames': ['blood glucose meter'], 'description': 'The rationale to conduct this study is that Hygieia hypothesizes the software will effectively and safely optimize glucose control in insulin-requiring patients with type-1 and type-2 diabetes. The software was designed to provide safe insulin dosage recommendations.', 'armGroupLabels': ['Group I', 'Group II', 'Group III']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55416', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'International Diabetes Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Richard M Bergenstal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'International Diabetes Center at Park Nicollet'}, {'name': 'Eran Bashan, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hygieia, Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HealthPartners Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, {'name': 'Hygieia, Inc', 'class': 'INDUSTRY'}, {'name': 'International Diabetes Center at Park Nicollet', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}