Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-31 @ 7:18 AM
Study NCT ID:
NCT07004504
Status:
COMPLETED
Last Update Posted:
2025-09-19
First Post:
2025-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MEnstrual Cycle pHase ANd dIabeteS Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-12-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2025-02-27', 'studyFirstSubmitQcDate': '2025-05-26', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean glucose', 'timeFrame': 'Between 1 and 12 months', 'description': 'Mean daily glucose based on CGM data'}], 'secondaryOutcomes': [{'measure': 'Time in range (TIR)', 'timeFrame': 'Between 1 and 12 months', 'description': 'Mean daily TIR based on CGM data'}, {'measure': 'Time above range (TAR)', 'timeFrame': 'Between 1 and 12 months', 'description': 'Mean daily TAR based on CGM data'}, {'measure': 'Time belwo range (TBR)', 'timeFrame': 'Between 1 and 12 months', 'description': 'Mean daily TBR based on CGM data'}, {'measure': 'Total daily insulin', 'timeFrame': 'Between 1 and 12 months', 'description': 'Mean daily total insulin based on insulin pump data'}, {'measure': 'Total basal insulin', 'timeFrame': 'Between 1 and 12 months', 'description': 'Mean daily total basal insulin based on insulin pump data'}, {'measure': 'Total bolus insulin', 'timeFrame': 'Between 1 and 12 months', 'description': 'Mean daily total bolus insulin based on insulin pump data'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Insulin sensitivity', 'Menstrual cycle', 'Diabetes management'], 'conditions': ['Type 1 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '24319120', 'type': 'BACKGROUND', 'citation': 'Schiavon M, Dalla Man C, Kudva YC, Basu A, Cobelli C. Quantitative estimation of insulin sensitivity in type 1 diabetic subjects wearing a sensor-augmented insulin pump. Diabetes Care. 2014;37(5):1216-23. doi: 10.2337/dc13-1120. Epub 2013 Dec 6.'}]}, 'descriptionModule': {'briefSummary': 'This study examines how menstrual cycle phases affect glycemic control and insulin requirements in women with type 1 diabetes (T1D). It aims to analyze differences in insulin needs and glucose levels between follicular and luteal phases using data from the Tidepool Data Platform. Key parameters include mean glucose, Time in Range (TIR), and total insulin administration. Secondary objectives involve assessing phase-specific glucose fluctuations, aggregated differences, and insulin adjustment strategies. The study follows a decentralized, anonymous data collection approach with participants using CGMs and insulin pumps or smart pens. Statistical analysis includes linear mixed-effects modeling to compare glycemic variability across cycle phases. Findings aim to enhance our understanding of diabetes management during the menstrual cycle and potentially inform future treatment strategies.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study includes adults (18+) living with type 1 diabetes (T1D) who use a continuous glucose monitoring (CGM) system and either an insulin pump or a smart pen for insulin delivery. Participants must be willing to upload diabetes-related data to the Tidepool Data Platform, track and share their menstrual cycle data, and provide consent for their anonymized data to be used in research.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\nPeople are eligible to participate in the study if they:\n\n* are living with T1D;\n* are willing to upload diabetes-related data to the Tidepool Data Platform;\n* are using a continuous glucose monitoring (CGM) system;\n* are using an insulin pump or a smart pen for most of their insulin delivery;\n* are willing to track and share their menstrual cycle data;\n* are 18 years old or older;\n* give consent to share their anonymized data for research.'}, 'identificationModule': {'nctId': 'NCT07004504', 'acronym': 'MECHANISM', 'briefTitle': 'MEnstrual Cycle pHase ANd dIabeteS Management', 'organization': {'class': 'OTHER', 'fullName': 'DCB Research AG'}, 'officialTitle': 'MEnstrual Cycle pHase ANd dIabeteS Management', 'orgStudyIdInfo': {'id': 'MECHANISM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Single Arm', 'description': 'The study cohort consists of women with type 1 diabetes (T1D) who use continuous glucose monitoring (CGM) and insulin pumps to manage their diabetes. Participants will anonymously upload their glucose and insulin delivery data, along with self-reported menstrual cycle information. The study focuses on analyzing variations in insulin requirements and glycemic control across menstrual cycle phases, without introducing any direct interventions.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'DCB Research AG', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Martina Rothenbühler, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'DCB Research AG'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DCB Research AG', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}