MEnstrual Cycle pHase ANd dIabeteS Management (MECHANISM)

DCB Research

Status: Completed

Conditions: Type 1 Diabetes Mellitus

Study type: Observational

Funder types: Other

Identifiers

NCT07004504

MECHANISM

Details and patient eligibility

About

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 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 across cycle phases. Findings aim to enhance our understanding of diabetes management during the menstrual cycle and potentially inform future treatment strategies.

Enrollment: 77 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

77 participants in 1 patient group

Single Arm

Description:

The study cohort consists of women with type 1 diabetes (T1D) who use continuous glucose monitoring (CGM) and insulin pumps to manage their diabetes. Participants will anonymously upload their glucose and insulin delivery data, along with self-reported menstrual cycle information. The study focuses on analyzing variations in insulin requirements and glycemic control across menstrual cycle phases, without introducing any direct interventions.