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OpenTrials
Completed

NCT Number: NCT07004504

MEnstrual Cycle pHase ANd dIabeteS Management

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Immune System Diseases Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

DCB Research AG

Bern, 3010, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Insulin sensitivity

    Time frame: Between 1 and 12 months

    Insulin sensitivity quantified by using a hierarchical Bayesian state-space model that estimates a latent insulin sensitivity parameter from CGM time series data.

Secondary outcomes

  1. Mean glucose

    Time frame: Between 1 and 12 months

    Mean daily glucose based on CGM data

  2. Time in range (TIR)

    Time frame: Between 1 and 12 months

    Mean daily TIR based on CGM data

  3. Time above range (TAR)

    Time frame: Between 1 and 12 months

    Mean daily TAR based on CGM data

  4. Time belwo range (TBR)

    Time frame: Between 1 and 12 months

    Mean daily TBR based on CGM data

  5. Total daily insulin

    Time frame: Between 1 and 12 months

    Mean daily total insulin based on insulin pump data

  6. Total basal insulin

    Time frame: Between 1 and 12 months

    Mean daily total basal insulin based on insulin pump data

  7. Total bolus insulin

    Time frame: Between 1 and 12 months

    Mean daily total bolus insulin based on insulin pump data

Sponsors and collaborators

Lead sponsor

DCB Research AG

Other

Registry information

Acronym: MECHANISM

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 4, 2025
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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