NCT05258292

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 86 (estimated)
• Sponsor: Institut de Recherches Cliniques de Montreal · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type1diabetes

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-05-02
• Primary completion: 2026-04-01
• Completion: 2026-05-31
• First posted: 2022-02-28
• Last updated: 2026-03-05

Locations

1 site across 1 country: Canada