Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-26 @ 6:07 AM
Study NCT ID:
NCT06948760
Status:
RECRUITING
Last Update Posted:
2025-07-29
First Post:
2025-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Testing a Conversion Factor for a More Rapidly Acting Insulin in an Automated Insulin Delivery System Among Adolescents With T1D
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': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-24', 'studyFirstSubmitDate': '2025-04-21', 'studyFirstSubmitQcDate': '2025-04-21', 'lastUpdatePostDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time in Range (70-180 mg/dL)', 'timeFrame': '14 days', 'description': 'The primary endpoint of the clinical trial will be the difference in time in range glucose (70-180 mg/dL) by CGM (adjusted for baseline TIR) between those on the Lyumjev conversion factor and those remaining on optimized settings of Humalog/Novolog.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Type 1 Diabetes', 'Continuous Glucose Monitor (CGM)', 'Tandem t:slim Insulin Pump with Control-IQ Technology (CIQ)', 'Lyumjev insulin', 'Conversion Factor'], 'conditions': ['Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': 'A randomized controlled trial of Control-IQ, assessing glycemic control (time-in-range 70-180 mg/dL) for Lyumjev insulin (in which the insulin settings have been determined using an experimental conversion factor) as compared to Humalog or Novolog (using optimized settings)', 'detailedDescription': 'All participants will have a physician-driven insulin Optimization Phase using their home Humalog or Novolog in the Control-IQ control group. After this, participants will have a two-week baseline control phase to assess time-in-range on the optimized insulin settings. Participants will then be randomized to switch to Lyumjev insulin (with insulin settings determined using the conversion factor) or remain on their home Humalog or Novolog for a two-week period. Each group will have their time-in-range during the randomized phase compared to that during the baseline period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '22 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥12.0 and ≤22 years old at time of consent\n2. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year\n3. HbA1c \\>6.5 - 12%\n4. Currently using insulin for at least six months\n5. Currently using the Tandem t:slim insulin pump with Control-IQ Technology® for at least two months\n6. Using insulin parameters such as carbohydrate ratio and correction factors consistently on their pump in order to dose insulin for meals or corrections\n7. Access to internet and willingness to upload data during the study as needed, including data generated prior to the start of the study\n8. For females, not currently known to be pregnant or breastfeeding\n9. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of childbearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.\n10. Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, prior to the insulin Optimization Phase and for the duration of the study\n11. Willingness to use Lyumjev if randomized to the experimental treatment arm\n12. Total daily insulin dose (TDD) at least 10 U/day and not more than 100 U/day\n13. Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, biguanides, sulfonylureas and nutraceuticals)\n14. Willingness to eat at least 1 g/kg of carbohydrate per day\n15. Willingness to check ketones per study protocol using home urine ketone strips\n16. An understanding and willingness to follow the protocol and signed informed consent\n\nExclusion Criteria:\n\n1. History of diabetic ketoacidosis (DKA) in the 6 months prior to enrollment\n2. Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment\n3. Current HbA1c \\<6.5 or \\>12\n4. Pregnancy or intent to become pregnant during the trial\n5. Currently being treated for a seizure disorder\n6. Planned surgery during study duration\n7. Need for treatment with oral steroid\n8. Treatment with any non-insulin glucose-lowering agent (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and nutraceuticals)\n9. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.'}, 'identificationModule': {'nctId': 'NCT06948760', 'acronym': 'Lpad Lyumjev', 'briefTitle': 'Testing a Conversion Factor for a More Rapidly Acting Insulin in an Automated Insulin Delivery System Among Adolescents With T1D', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Testing a Conversion Factor for a More Rapidly Acting Insulin in an Automated Insulin Delivery System Among Adolescents With T1D [Launchpad Lyumjev]', 'orgStudyIdInfo': {'id': '302376'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lyumjev insulin using settings determined by experimental conversion factor', 'description': 'All participants will have a physician-driven insulin Optimization Phase using their home Humalog or Novolog in the Control-IQ control group. After this, participants will have a two-week baseline control phase to assess time-in-range on the optimized insulin settings. Participants will then use Lyumjev insulin for a two-week period with insulin settings determined using the conversion factor.', 'interventionNames': ['Device: Control-IQ insulin pump with Lyumjev insulin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Humalog or Novolog using optimized insulin settings', 'description': 'All participants will have a physician-driven insulin Optimization Phase using their home Humalog or Novolog in the Control-IQ control group. After this, participants will have a two-week baseline control phase to assess time-in-range on the optimized insulin settings. Participants will then remain on their home Humalog or Novolog for a two-week period using the optimized insulin settings. Each group will have their time-in-range during the randomized phase compared to that during the baseline period.', 'interventionNames': ['Device: Control-IQ insulin pump with Humalog or Novolog']}], 'interventions': [{'name': 'Control-IQ insulin pump with Lyumjev insulin', 'type': 'DEVICE', 'otherNames': ['Experimental Group'], 'description': 'Control-IQ insulin pump with insulin using settings determined by experimental conversion factor', 'armGroupLabels': ['Lyumjev insulin using settings determined by experimental conversion factor']}, {'name': 'Control-IQ insulin pump with Humalog or Novolog', 'type': 'DEVICE', 'otherNames': ['Control Group'], 'description': 'Control-IQ insulin pump with Humalog or Novolog using optimized insulin settings', 'armGroupLabels': ['Humalog or Novolog using optimized insulin settings']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mark DeBoer, MD', 'role': 'CONTACT', 'email': 'MDD5Z@virginia.edu', 'phone': '434-924-5956'}, {'name': 'Marc Breton, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Virginia Center for Diabetes Technology', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'centralContacts': [{'name': 'Sara Prince, RN', 'role': 'CONTACT', 'email': 'SP4SA@uvahealth.org', 'phone': '(434) 320-5599'}, {'name': 'Lianna Smith', 'role': 'CONTACT', 'email': 'LHS7PX@uvahealth.org', 'phone': '(434) 284-0893'}], 'overallOfficials': [{'name': 'Mark DeBoer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia Center for Diabetes Technology'}]}, 'ipdSharingStatementModule': {'url': 'https://med.virginia.edu/diabetes-technology/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Data will be available for three years from the publication of the manuscript.', 'ipdSharing': 'YES', 'description': 'De-identified data will be made available after publication of the manuscript.', 'accessCriteria': 'Data will be available on reasonable request after Data Sharing Agreements have been formulated.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mark D. DeBoer, MD, MSc., MCR', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Virginia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mark D. DeBoer, MD, MSc., MCR', 'investigatorAffiliation': 'University of Virginia'}}}}