MEnstrual Cycle pHase ANd dIabeteS Management

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

77 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-14

Study Completion Date

2024-12-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 1 Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Single Arm

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.

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No