MEnstrual Cycle pHase ANd dIabeteS Management

This study evaluates the impact of menstrual cycle phases on insulin sensitivity, glycaemic control, and insulin requirements in women with type 1 diabetes (T1D). It aims to quantify differences between the follicular and luteal phases using data from the Tidepool Data Platform. Key endpoints include modelled insulin sensitivity, mean glucose, Time in Range (TIR), and total insulin dose. Secondary objectives include assessing phase-specific variability in the endpoints and differences between participants. The study follows a decentralized, anonymized data collection approach, with participants using continuous glucose monitors (CGMs) and insulin pumps or smart pens. Glycaemic outcomes and insulin requirements will be compared across menstrual cycle phases using linear mixed-effects models to account for repeated measures within individuals. Cycle phase-specific variation in insulin sensitivity will be quantified using a hierarchical Bayesian state-space model, which estimates a latent insulin sensitivity parameter from CGM time series data while accounting for measurement noise and temporal dynamics. The findings are expected to improve understanding of glycaemic dynamics across the menstrual cycle and inform future diabetes management strategies.

NCT Number	NCT07004504
Lead Sponsor	DCB Research AG
Conditions	Type 1 Diabetes Mellitus
Enrollment	77 participants
Start Date	2023-12-14
Primary Completion	2024-12-29 (estimated)
Study Completion	2024-12-29 (estimated)
Updated on ClinicalTrials.gov	2026-03-25