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Recruiting NCT05258292

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

◆ AI Clinical Summary

This study examines how blood sugar levels change throughout a woman's menstrual cycle in those with type 1 diabetes. Researchers want to understand why insulin needs may vary at different times of the month and how this affects blood sugar control.

Key Objective: This research may help doctors better understand and predict blood sugar changes during the menstrual cycle, potentially leading to improved diabetes management strategies for women.

Who to Consider: Women with type 1 diabetes who experience changes in their blood sugar or insulin needs during their menstrual cycle should consider enrolling in this study.

Trial Parameters

Condition Type1diabetes
Sponsor Institut de Recherches Cliniques de Montreal
Study Type OBSERVATIONAL
Phase N/A
Enrollment 86
Sex FEMALE
Min Age 18 Years
Max Age 50 Years
Start Date 2022-05-02
Completion 2026-04-01
Interventions
Continuous glucose monitoringInsulinPremenstrual symptoms

Brief 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 Criteria

Inclusion Criteria: 1. Females aged 18 to 50 living in Canada. 2. Clinical diagnosis of type 1 diabetes or latent autoimmune diabetes in adults (LADA) for at least one year. 3. Using insulin pump therapy, multiple daily injections or automated insulin delivery systems for at least 3 months. 4. Using a continuous glucose monitoring (CGM) system. 5. Having at least one menses in the last 40 days. 6. Accepting to share CGM data with the research team and if applicable insulin pump data.This access will be limited to the study period. 7. Having a smartphone or tablet to follow menstrual cycles. 8. Stable weight (less than 5% variation in the last 3 months). Exclusion Criteria: 1. Using a hormonal contraception method that eliminates menses (Depo Provera, progestin intrauterine device, extented-cycle regimen with birth control pill) 2. Using regular insulin (Entuzity U500, Novolin ge Toronto or Humulin R). 3. Clinically significant nephropathy (eGFR \< 30 ml/min/1.73m2, planned or on dialys

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