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MEnstrual Cycle pHase ANd dIabeteS Management

NCT07004504 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 77

Last updated 2026-03-25

No results posted yet for this study

Summary

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.

Conditions

  • Type 1 Diabetes Mellitus

Sponsors & Collaborators

  • DCB Research AG

    lead OTHER

Principal Investigators

  • Martina Rothenbühler, PhD · DCB Research AG

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-14
Primary Completion
2024-12-29
Completion
2024-12-29

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07004504 on ClinicalTrials.gov