Actively Recruiting
Glycemic Variations During the Menstrual Cycle in Women With Type 1 Diabetes
Led by Institut de Recherches Cliniques de Montreal · Updated on 2026-03-05
86
Participants Needed
1
Research Sites
212 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Glycemic Variations During the Menstrual Cycle in Women With Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 50 living in Canada
- Clinical diagnosis of type 1 diabetes or latent autoimmune diabetes in adults (LADA) for at least one year
- Using insulin pump therapy, multiple daily injections, or automated insulin delivery systems for at least 3 months
- Using a continuous glucose monitoring (CGM) system
- Having at least one menstrual period in the last 40 days
- Agreeing to share CGM data and insulin pump data if applicable during the study period
- Having a smartphone or tablet to track menstrual cycles
- Stable weight with less than 5% variation in the last 3 months
You will not qualify if you...
- Using hormonal contraception methods that stop menstruation (e.g., Depo Provera, progestin intrauterine device, extended-cycle birth control pill)
- Using regular insulin types such as Entuzity U500, Novolin ge Toronto, or Humulin R
- Significant kidney disease or neuropathy as judged by the investigator
- Recent acute heart or vascular event within the last 6 months
- Planned changes to insulin type, CGM sensor, insulin pump, or automated insulin device during the study
- Planned changes to contraception methods during the study
- Expected use of acetaminophen above 1g every 6 hours during the study
- Currently pregnant or trying to become pregnant
- Breastfeeding
- Uncontrolled thyroid disease or unstable thyroid treatment
- Severe low blood sugar episode within two weeks before screening
- Severe high blood sugar episodes requiring hospitalization in the last 3 months
- Current use of glucocorticoid medication except low stable doses or inhaled steroids
- Use of certain medications affecting stomach emptying or oral anti-diabetic agents unless stable for 3 months
- Use of SGLT-2 inhibitors unless stable for at least 3 months and ketone testing performed
- Other serious illnesses interfering with study participation
- Anticipated major changes in exercise or diet during the study
- Planned radiologic exams incompatible with CGM wear for more than 10 days
- Unable or unwilling to complete the study
- Changes in hypothyroidism medication dose within last 6 weeks
AI-Screening
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Trial Site Locations
Total: 1 location
1
Institut de recherches cliniques de Montréal
Montreal, Quebec, Canada, H2W 1R7
Actively Recruiting
Research Team
A
Anne Bonhoure
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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