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

NCT05258292 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 86

Last updated 2026-03-05

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Institut de Recherches Cliniques de Montreal

    lead OTHER

Principal Investigators

  • Rémi Rabasa-Lhoret · Institut de recherches cliniques de Montréal

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-02
Primary Completion
2026-04-01
Completion
2026-05-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05258292 on ClinicalTrials.gov