Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:58 PM
Study NCT ID:
NCT06021158
Status:
RECRUITING
Last Update Posted:
2024-03-29
First Post:
2023-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Trial to Compare Automated Lyumjev Delivery With Carbohydrate Counting, Qualitative Meal-size Estimation, and Meal Detection in 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-28', 'studyFirstSubmitDate': '2023-08-24', 'studyFirstSubmitQcDate': '2023-08-30', 'lastUpdatePostDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of time of glucose levels spent in the target range (3.9-10.0 mmol/L)', 'timeFrame': '14 days'}], 'secondaryOutcomes': [{'measure': 'Percentage of time of glucose levels spent in the following ranges: - between 3.9 and 7.8 mmol/L - below 3.9 mmol/L - below 3.0 mmol/L - above 10.0 mmol/L - above 13.9 mmol/L', 'timeFrame': '14 days'}, {'measure': 'Mean glucose levels', 'timeFrame': '14 days'}, {'measure': 'Standard deviation of glucose levels', 'timeFrame': '14 days'}, {'measure': 'Standard deviation of insulin delivery', 'timeFrame': '14 days'}, {'measure': 'Coefficient of variance of glucose levels', 'timeFrame': '14 days'}, {'measure': 'Coefficient of variance of insulin delivery', 'timeFrame': '14 days'}, {'measure': 'Total insulin delivery (overall, basal, and bolus)', 'timeFrame': '14 days'}, {'measure': 'Area under the sensor glucose concentration-time curve (AUC) from 0-1 hours, 0-2 hours, 0-3 hours, 0-4 hours, and 0-5 hours after meal insulin boluses', 'timeFrame': '14 days'}, {'measure': 'Area under the sensor glucose concentration-time curve (AUC) from 1-2 hours, 2-3 hours, 3-4 hours, and 4-5 hours after meal insulin boluses', 'timeFrame': '14 days'}, {'measure': 'Decremental sensor glucose concentration for the duration of announced exercise periods', 'timeFrame': '14 days'}, {'measure': 'Area under the sensor glucose concentration-time curve (AUC) from 0-1 hours, 0-2 hours, 0-3 hours, 0-4 hours, and 0-5 hours after the end of announced exercise periods', 'timeFrame': '14 days'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 1', 'Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': 'The goal of this pilot trial is to compare three meal strategies using an ultra-rapid insulin (Lyumjev) and an automated insulin delivery system. The meal strategies to be investigated are carbohydrate counting, qualitative meal announcement (e.g., low-carb meal), and meal detection. The investigators are doing this research to evaluate if carbohydrate counting can be simplified in patients with type 1 diabetes.\n\nParticipants will test each meal strategy in random order, and each meal strategy will be 21 days long. For the duration of each meal strategy, participants will use an automated insulin delivery system or "artificial pancreas" with an ultra-rapid insulin called Lyumjev.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment per local and international guideline criteria.\n* Insulin pump use for at least 3 months.\n* Individuals of childbearing potential must agree to use a highly effective method of birth control.\n* Willing to switch to Lyumjev insulin for the duration of the study.\n\nExclusion Criteria:\n\n* Use of oral antihyperglycemic agents within 2 weeks of admission (SGLT2i, metformin…); 1 month for GLP1-RA.\n* Use of glucocorticoids (except low, stable doses and inhaled steroids).\n* Use of hydroxyurea.\n* Planned or ongoing pregnancy.\n* Breastfeeding.\n* Diabetic ketoacidosis and/or severe hypoglycemia episode (defined as requiring the assistance of another person, due to altered consciousness, to administer carbohydrates, glucagon, or other resuscitative actions) within one month of admission.\n* Clinically significant retinopathy, nephropathy, or neuropathy as judged by the investigator.\n* Recent (\\<6 months) acute macrovascular event e.g., acute coronary syndrome or cardiac surgery.\n* Known hypersensitivity to the study drug or its excipients.\n* Other serious medical illness likely to interfere with study participation or with the ability to complete the trial, as judged by the investigator."}, 'identificationModule': {'nctId': 'NCT06021158', 'acronym': 'Lilly-MEALS', 'briefTitle': 'A Trial to Compare Automated Lyumjev Delivery With Carbohydrate Counting, Qualitative Meal-size Estimation, and Meal Detection in Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}, 'officialTitle': 'A Randomized, Crossover, Pilot Trial to Compare Automated Lyumjev Delivery With Carbohydrate Counting, Qualitative Meal-size Estimation, and Meal Detection in Type 1 Diabetes', 'orgStudyIdInfo': {'id': '2024-9583'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'AID-count', 'interventionNames': ['Combination Product: Hybrid automated Lyumjev delivery system with carbohydrate counting']}, {'type': 'EXPERIMENTAL', 'label': 'AID-estimate', 'interventionNames': ['Combination Product: Hybrid automated Lyumjev delivery system with meal size estimation']}, {'type': 'EXPERIMENTAL', 'label': 'AID-detect', 'interventionNames': ['Combination Product: Fully automated Lyumjev delivery system with meal detection']}], 'interventions': [{'name': 'Hybrid automated Lyumjev delivery system with carbohydrate counting', 'type': 'COMBINATION_PRODUCT', 'description': 'In this system, a Lyumjev insulin bolus is initiated at mealtime based on the total grams of carbohydrates counted. This is the same as commercial hybrid closed-loop insulin therapy (standard treatment).', 'armGroupLabels': ['AID-count']}, {'name': 'Hybrid automated Lyumjev delivery system with meal size estimation', 'type': 'COMBINATION_PRODUCT', 'description': 'In this system, a Lyumjev insulin bolus is initiated at mealtime based on the qualitative amount of carbohydrates estimated (e.g., low-carb meal).', 'armGroupLabels': ['AID-estimate']}, {'name': 'Fully automated Lyumjev delivery system with meal detection', 'type': 'COMBINATION_PRODUCT', 'description': 'In this system, the patient does not initiate a Lyumjev insulin bolus at mealtime. An algorithm is used to detect a meal and administer a subsequent bolus, rather than requiring a carbohydrate count.', 'armGroupLabels': ['AID-detect']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H4A 3J1', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Carolyne Schumacher', 'role': 'CONTACT', 'email': 'carolyne.schumacher@mail.mcgill.ca', 'phone': '5142585431'}], 'facility': 'Research Institute of the McGill University Health Centre (RI-MUHC)', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'centralContacts': [{'name': 'Carolyne Schumacher', 'role': 'CONTACT', 'email': 'carolyne.schumacher@mail.mcgill.ca', 'phone': '514-258-5431'}], 'overallOfficials': [{'name': 'Michael Tsoukas, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Victoria Hospital, Belfast'}, {'name': 'Ahmad Haidar, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Research Institute of the McGill University University Health Centre'}, {'name': 'Laurent Legault, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': "Montreal Children's Hospital of the MUHC"}, {'name': 'Melissa-Rosina Pasqua, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Research Institute of the McGill University Health Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'After the completion of the trial, raw data will be shared for academic purposes upon request, according to the Materials Transfer Agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McGill University Health Centre/Research Institute of the McGill University Health Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Endocrinology & Metabolism', 'investigatorFullName': 'Michael Tsoukas', 'investigatorAffiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}}}}