MEnstrual Cycle pHase ANd dIabeteS Management

Completed

• Conditions: Type 1 Diabetes Mellitus

• Registration Number: NCT07004504
• Lead Sponsor: DCB Research AG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-14
• Primary Completion: 2024-12-29
• Study Completion: 2024-12-29
• Study First Submitted: 2025-02-27
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-26
• Last Update Submitted: 2025-05-26
• Study First Posted: 2025-06-04
• Last Update Posted: 2025-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 82

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Insulin sensitivity	Between 1 and 12 months	Mean daily insulin sensitivity: Insulin sensitivity is estimated as suggested by Schiavon et al. The Schiavon estimator uses CGM, insulin, and carbohydrate data to compute an estimate of insulin sensitivity following each meal.

Secondary Outcome Measures

Name	Time	Method
Mean glucose	Between 1 and 12 months	Mean daily glucose based on CGM data
Time in range (TIR)	Between 1 and 12 months	Mean daily TIR based on CGM data
Time above range (TAR)	Between 1 and 12 months	Mean daily TAR based on CGM data
Time belwo range (TBR)	Between 1 and 12 months	Mean daily TBR based on CGM data
Total daily insulin	Between 1 and 12 months	Mean daily total insulin based on insulin pump data
Total basal insulin	Between 1 and 12 months	Mean daily total basal insulin based on insulin pump data
Total bolus insulin	Between 1 and 12 months	Mean daily total bolus insulin based on insulin pump data

Trial Locations

Locations (1)

DCB Research AG; 🇨🇭 Bern, Switzerland