Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:42 AM
Study NCT ID:
NCT07351318
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-03-02
First Post:
2026-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Estimating Insulin Sensitivity in Pregnancies With Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'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': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2026-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-26', 'studyFirstSubmitDate': '2026-01-09', 'studyFirstSubmitQcDate': '2026-01-09', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Time in Target Range', 'timeFrame': 'Assessed every 2 weeks from 4 weeks pre-conception to 6 months post partum', 'description': 'Percentage of time blood glucose was 70mg/dL and 180mg/dL as per CGM'}], 'secondaryOutcomes': [{'measure': 'Percent Time Below Range', 'timeFrame': 'Assessed every 2 weeks from 4 weeks pre-conception to 6 months post partum', 'description': 'Percentage of time blood glucose was below 70mg/dL as per CGM'}, {'measure': 'Percent Time Above Range', 'timeFrame': 'Assessed every 2 weeks from 4 weeks pre-conception to 6 months post partum', 'description': 'Percentage of time blood glucose was above 180 mg/dl as per CGM'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pregnancy', 'type 1 diabetes', 'diabetes', 'insulin', 'insulin sensitivity', 'gestation'], 'conditions': ['Pregnancy', 'Type 1 Diabetes (T1D)']}, 'descriptionModule': {'briefSummary': "The investigators want to learn how the body's response to insulin changes during pregnancy in people with Type 1 Diabetes.\n\nIn this study, the investigators will look at information from people who used a Dexcom continuous glucose monitor (CGM) and a Tandem insulin pump while they were pregnant. Participants will fill out an online survey and agree to share their device data. The investigators will use this information to see how insulin sensitivity changes from three months before pregnancy to six months after the baby is born.", 'detailedDescription': "The aim of this retrospective observational study is to collect continuous glucose monitor (CGM) and insulin pump data from pregnant individuals with Type 1 Diabetes, from 3 months before conception to 6 months after delivery. This data will be used to estimate how insulin sensitivity (IS) changes across gestation, with the goal of better understanding glucose-insulin dynamics during pregnancy and develop algorithms for adapting insulin administration across gestational ages.\n\nParticipants will complete an online survey where they will provide their insulin pump serial number, date of delivery, gestational week at delivery, date of last menstrual cycle (if known), and other optional demographic information. The study team will use this information to retrieve participants' CGM and insulin infusion data from 3 months before conception to 6 months after delivery.\n\nUp to 200 participants will be screened, with the goal of reaching 100 screened participants."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult individuals with T1D who received pregnancy care within the last 8 years in one of the participating sites: UVA Health (Charlottesville, VA), Northwestern Memorial Hospital (Chicago, IL).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>=18 years old\n* Pregnant within the last 8 years\n* Diagnosed with type 1 diabetes for at least one year at the time of pregnancy\n* Use of a Dexcom CGM system (Dexcom, Inc., CA) and Tandem insulin infusion pump (Tandem Diabetes Care, CA) across gestation, and willing to share data from this pregnancy with study staff.'}, 'identificationModule': {'nctId': 'NCT07351318', 'acronym': 'EISP', 'briefTitle': 'Estimating Insulin Sensitivity in Pregnancies With Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Estimating Insulin Sensitivity Fluctuations Across Pregnancies With Type 1 Diabetes', 'orgStudyIdInfo': {'id': '20254424'}, 'secondaryIdInfos': [{'id': '2-APF-2025-1678-A-N', 'type': 'OTHER_GRANT', 'domain': 'BreakthroughT1D'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'UVA Health', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Northwestern Memorial Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jacopo Pavan', 'investigatorAffiliation': 'University of Virginia'}}}}