Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05258292

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

Sponsor: Institut de Recherches Cliniques de Montreal

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 50 Years

Study Type

OBSERVATIONAL

Enrollment

86

Start Date

2022-05-02

Completion Date

2026-05-31

Last Updated

2026-03-05

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Continuous glucose monitoring

Glucose levels will be measured using continuous glucose monitoring

DRUG

Insulin

Insulin doses will be retrieved from insulin pump reports (for insulin pump users) or journals for (for multiple daily injections users)

OTHER

Premenstrual symptoms

Premenstrual symptoms will be assessed using the Premenstrual symptoms screening tool

OTHER

Ovulation kits

Ovulation testing will be done using ovulation kits

DEVICE

Fitbit Inspire 2

Physical activity will be assessed using the Fitbit Inspire 2

OTHER

Keenoa

Food intake will be assessed using the Keenoa phone application

OTHER

Menstrual cycle

The application My Calendar will be used to record information on the menstrual cycle

Locations (1)

Institut de recherches cliniques de Montréal

Montreal, Quebec, Canada