RecruitingNCT05258292

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


Sponsor

Institut de Recherches Cliniques de Montreal

Enrollment

86 participants

Start Date

May 2, 2022

Study Type

OBSERVATIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is tracking how blood sugar levels change throughout the menstrual cycle in women with type 1 diabetes. Researchers hope to better understand these patterns to help improve insulin dosing and diabetes management during hormonal changes. **You may be eligible if...** - You are a woman between 18 and 50 years old living in Canada - You have been diagnosed with type 1 diabetes or latent autoimmune diabetes in adults (LADA) for at least one year - You use an insulin pump, multiple daily insulin injections, or an automated insulin delivery system - You use a continuous glucose monitor (CGM) - You have had at least one menstrual period in the last 40 days - Your weight has been stable (less than 5% change in the last 3 months) **You may NOT be eligible if...** - You use a hormonal contraceptive that eliminates your period (such as Depo-Provera, a hormonal IUD, or certain birth control pills) - You have another condition affecting blood sugar control Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEContinuous glucose monitoring

Glucose levels will be measured using continuous glucose monitoring

DRUGInsulin

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

OTHERPremenstrual symptoms

Premenstrual symptoms will be assessed using the Premenstrual symptoms screening tool

OTHEROvulation kits

Ovulation testing will be done using ovulation kits

DEVICEFitbit Inspire 2

Physical activity will be assessed using the Fitbit Inspire 2

OTHERKeenoa

Food intake will be assessed using the Keenoa phone application

OTHERMenstrual 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

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NCT05258292


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