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

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug, Device
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• 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.

• Having at least one menses in the last 40 days.

• Accepting to share CGM data with the research team and if applicable insulin pump data.This access will be limited to the study period.

• Having a smartphone or tablet to follow menstrual cycles.

• Stable weight (less than 5% variation in the last 3 months).

Locations
Other Locations
Canada
Institut de recherches cliniques de Montréal
RECRUITING
Montreal
Contact Information
Primary
Anne Bonhoure
anne.bonhoure@ircm.qc.ca
514-987-5500
Time Frame
Start Date: 2022-05-02
Estimated Completion Date: 2025-05-31
Participants
Target number of participants: 86
Treatments
Women with type 1 diabetes
Related Therapeutic Areas
Sponsors
Leads: Institut de Recherches Cliniques de Montreal

This content was sourced from clinicaltrials.gov