Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
Study NCT ID:
NCT03849612
Status:
COMPLETED
Last Update Posted:
2019-04-25
First Post:
2019-02-19
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 Mellitus
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': '2019-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-24', 'studyFirstSubmitDate': '2019-02-19', 'studyFirstSubmitQcDate': '2019-02-20', 'lastUpdatePostDateStruct': {'date': '2019-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Adverse Events (AEs)', 'timeFrame': 'In-Patient Period (5 Days)', 'description': 'Number of AEs'}, {'measure': 'Continuous Glucose Monitor (CGM) Measured Percentage of Time <70 mg/dL', 'timeFrame': 'In-Patient Period (5 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': '32940537', 'type': 'DERIVED', 'citation': 'Christiansen M, Bartee A, Lalonde A, Jones RE, Katz M, Wolpert H, Brazg R. Performance of an Automated Insulin Delivery System: Results of Early Phase Feasibility Studies. Diabetes Technol Ther. 2021 Mar;23(3):187-194. doi: 10.1089/dia.2020.0318. Epub 2020 Oct 5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate whether an Automated Insulin Delivery (AID) System is safe to use and functions as intended with personalized basal insulin rates and when basal insulin rates are increased.'}, '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': 'NCT03849612', 'briefTitle': 'A Study of an Automated Insulin Delivery System in Adult Participants With Type 1 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'An Early Feasibility Study to Evaluate Basal Initialization Parameters in an Automated Insulin Delivery System in Adult Patients With Type 1 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '17175'}, 'secondaryIdInfos': [{'id': 'F3Z-MC-IORB', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AID System Containing Insulin Lispro', 'description': 'The AID system is comprised of a continuous subcutaneous insulin infusion (CSII) pump component with a hybrid closed-loop control (HCLC) 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': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Diablo Clinical Research', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}], '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'}}}}