Clinical trial NCT07004504: MEnstrual Cycle pHase ANd dIabeteS Management
Official title: MEnstrual Cycle pHase ANd dIabeteS Management
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes Mellitus
Keywords: Insulin sensitivity
Menstrual cycle
Diabetes management
Lead sponsor: DCB Research AG
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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, translating to changing levels of insulin sensitivities, 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 and changes in insulin sensitivity across cycle phases. The study also explores whether clusters of glycemic control and insulin sensitivity patterns can be identified among participants. Findings aim to enhance our understanding of diabetes management during the menstrual cycle and potentially inform future treatment strategies.


Eligibility criteria: Inclusion criteria

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.

Primary outcomes:
measure: Insulin sensitivity
timeFrame: Between 1 and 12 months
Secondary outcomes:
measure: Mean glucose
timeFrame: Between 1 and 12 months
measure: Time in range (TIR)
timeFrame: Between 1 and 12 months
measure: Time above range (TAR)
timeFrame: Between 1 and 12 months
measure: Time belwo range (TBR)
timeFrame: Between 1 and 12 months
measure: Total daily insulin
timeFrame: Between 1 and 12 months
measure: Total basal insulin
timeFrame: Between 1 and 12 months
measure: Total bolus insulin
timeFrame: Between 1 and 12 months
Other outcomes:
measure: Visual description of trajectories in insulin sensitivity throughout the menstrual cycle
timeFrame: Between 1 and 12 months
Locations:
city: Bern
country: Switzerland
facility: DCB Research AG
Study officials:
affiliation: DCB Research AG
name: Martina Rothenbühler, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.