NCT07004504Completed
MEnstrual Cycle pHase ANd dIabeteS Management
Source: ClinicalTrials.gov · Last updated 25 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 77 (actual)
- First submitted
- 27 Feb 2025
- Start date
- 14 Dec 2023
- Primary completion date
- 29 Dec 2024
- Lead sponsor
- DCB Research AG
- Diseases
- Type 1 diabetes
- NCT number
- NCT07004504
What you commit to
- Study type: Observational
- Participants enrolled: 77
- From 14 Dec 2023 to the primary completion date, 29 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- People are eligible to participate in the study if they:
- are living with T1D;
- are willing to upload diabetes-related data to the Tidepool Data Platform;
- are using a continuous glucose monitoring (CGM) system;
- are using an insulin pump or a smart pen for most of their insulin delivery;
- are willing to track and share their menstrual cycle data;
- are 18 years old or older;
- give consent to share their anonymized data for research.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| DCB Research AG Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.