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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.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
DCB Research AG
Bern, Switzerland
Start Date
December 14, 2023
Primary Completion Date
December 29, 2024
Completion Date
December 29, 2024
Last Updated
September 19, 2025
77
ACTUAL participants
Lead Sponsor
DCB Research AG
NCT07051005
NCT06390371
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT03228732