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GLYMETYGlycemic Variations During the Menstrual Cycle in Women With Type 1 Diabetes: the GLYMETY Study

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What is being collected

Data Collection

Who is being recruted

Behavior

+ Motor Activity

From 18 to 50 Years
+28 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: May 2022
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Summary

Principal SponsorInstitut de Recherches Cliniques de Montreal
Study ContactAnne Bonhoure
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 2, 2022

Actual date on which the first participant was enrolled.

In clinical practice, women living with type 1 diabetes frequently report that insulin requirements change across the menstrual cycle. Consequently, glycemic fluctuations are observed. This phenomenon could be explained by a decrease in insulin sensitivity during the second half of the menstrual cycle (luteal phase). Overall, despite an important proportion of women reporting glycemic and/or insulin variations across the menstrual cycle, studies to date have involved small sample sizes, and have had inconsistent results. The objective of this study will be to study glycemic fluctuations across the menstrual cycle using CGM data, alongside insulin data, in a large sample of women.

Official TitleGlycemic Variations During the Menstrual Cycle in Women With Type 1 Diabetes: the GLYMETY Study
NCT05258292
Principal SponsorInstitut de Recherches Cliniques de Montreal
Study ContactAnne Bonhoure
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

86 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorMotor Activity

Criteria

8 inclusion criteria required to participate
Females aged 18 to 50 living in Canada.
Clinical diagnosis of type 1 diabetes or latent autoimmune diabetes in adults (LADA) for at least one year.
Using insulin pump therapy, multiple daily injections or automated insulin delivery systems for at least 3 months.
Using a continuous glucose monitoring (CGM) system.
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20 exclusion criteria prevent from participating
Using a hormonal contraception method that eliminates menses (Depo Provera, progestin intrauterine device, extented-cycle regimen with birth control pill)
Using regular insulin (Entuzity U500, Novolin ge Toronto or Humulin R).
Clinically significant nephropathy (eGFR < 30 ml/min/1.73m2, planned or on dialysis) or neuropathy (e.g., known uncontrolled gastroparesis) as judged by the investigator.
Recent (< 6 months) acute macrovascular event (e.g., acute coronary syndrome or cardiac surgery).
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Institut de recherches cliniques de Montréal

Montreal, CanadaOpen Institut de recherches cliniques de Montréal in Google Maps
Recruiting
One Study Center