Ignite Creation Date:
2025-12-24 @ 7:30 PM
Ignite Modification Date:
2025-12-25 @ 5:12 PM
Study NCT ID:
NCT03890003
Status:
COMPLETED
Last Update Posted:
2019-06-05
First Post:
2019-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of an Automated Insulin Delivery System in Adult Participants With Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061268', 'term': 'Insulin Lispro'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06-01', 'completionDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-04', 'studyFirstSubmitDate': '2019-03-22', 'studyFirstSubmitQcDate': '2019-03-22', 'lastUpdatePostDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Adverse Events (AEs)', 'timeFrame': 'In-Patient Period (2 Days)', 'description': 'Number of AEs'}, {'measure': 'Continuous Glucose Monitor (CGM) Measured Percentage of Time <70 mg/dL', 'timeFrame': 'In-Patient Period (2 Days)', 'description': 'CGM measured percentage of time \\<70 milligrams per deciliter (mg/dL)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Type 1 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '33535013', 'type': 'DERIVED', 'citation': 'Pinsker JE, Bartee A, Katz M, Lalonde A, Jones R, Dassau E, Wolpert H. Predictive Low-Glucose Suspend Necessitates Less Carbohydrate Supplementation to Rescue Hypoglycemia: Need to Revisit Current Hypoglycemia Treatment Guidelines. Diabetes Technol Ther. 2021 Jul;23(7):512-516. doi: 10.1089/dia.2020.0619. Epub 2021 Feb 18.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this early feasibility study is to assess the predictive low glucose suspend (PLGS) feature's safety, functionality and performance."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants with T1DM for at least 2 years and who have used an insulin delivery system with any rapid-acting insulin analog for the preceding 6 months\n* Have a body mass index of 18.5 to 37 kilogram per meter squared\n* Have a hemoglobin A1c level ≥6.0% and ≤9.0%\n\nExclusion Criteria:\n\n* Have known allergies or history of hypersensitivity to insulin lispro\n* Have had an episode of severe hypoglycemia within the past 6 months\n* Have had more than 1 episode of diabetic ketoacidosis in the past 6 months'}, 'identificationModule': {'nctId': 'NCT03890003', 'briefTitle': 'A Study of an Automated Insulin Delivery System in Adult Participants With Type 1 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'An Early Feasibility Study to Evaluate the Predictive Low Glucose Suspend Functionality and Safety in an Automated Insulin Delivery System in Adult Patients With Type 1 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '17176'}, 'secondaryIdInfos': [{'id': 'F3Z-MC-IORC', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AID System Containing Insulin Lispro', 'description': 'The automated insulin delivery (AID) system is comprised of a continuous subcutaneous insulin infusion (CSII) pump component with a PLGS algorithm, and a continuous glucose monitor (CGM) component.', 'interventionNames': ['Device: AID System', 'Drug: Insulin Lispro']}], 'interventions': [{'name': 'AID System', 'type': 'DEVICE', 'otherNames': ['LY8888AU'], 'description': 'AID system', 'armGroupLabels': ['AID System Containing Insulin Lispro']}, {'name': 'Insulin Lispro', 'type': 'DRUG', 'otherNames': ['LY275585'], 'description': 'Individualized doses of insulin lispro administered via the AID system to maintain glycemic control, except during procedures designed to induce hyperglycemia and hypoglycemia.', 'armGroupLabels': ['AID System Containing Insulin Lispro']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93105', 'city': 'Santa Barbara', 'state': 'California', 'country': 'United States', 'facility': 'Sansum Diabetes Research Institute', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}