Status:
RECRUITING
Glycemic Variations During the Menstrual Cycle in Women With Type 1 Diabetes
Lead Sponsor:
Institut de Recherches Cliniques de Montreal
Conditions:
Type1diabetes
Eligibility:
FEMALE
18-50 years
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...
Eligibility Criteria
Inclusion
- Females 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 menses in the last 40 days.
- Accepting to share CGM data with the research team and if applicable insulin pump data.This access will be limited to the study period.
- Having a smartphone or tablet to follow menstrual cycles.
- Stable weight (less than 5% variation in the last 3 months).
Exclusion
- Using a hormonal contraception method that eliminates menses (Depo Provera, progestin intrauterine device, extented-cycle regimen with birth control pill)
- Using regular insulin (Entuzity U500, Novolin ge Toronto or Humulin R).
- Clinically significant nephropathy (eGFR \< 30 ml/min/1.73m2, planned or on dialysis) or neuropathy (e.g., known uncontrolled gastroparesis) as judged by the investigator.
- Recent (\< 6 months) acute macrovascular event (e.g., acute coronary syndrome or cardiac surgery).
- Anticipated therapeutic change (including change of insulin type and/or type of CGM sensor, insulin pump or AID (automated insulin device) system) between admission and end of the study.
- Anticipated change in contraception method or plan to begin or stop a contraceptive method.
- Anticipated need to use acetaminophen during the study period at a dose above 1g every 6 hours.
- Pregnancy (ongoing or current attempt to become pregnant)
- Breastfeeding
- Uncontrolled thyroid disease (TSH should be in target range and treatment stable for at least 6 weeks).
- Severe hypoglycemic episode within two weeks of screening
- Severe hyperglycemic episodes requiring hospitalization in the last 3 months.
- Current use of glucocorticoid medication (except low stable dose and inhaled steroids and stable adrenal insufficiency treatment e.g., Cortef®)
- Agents affecting gastric emptying (Motilium®, Victoza®, Ozempic®, Trulicity®, Byetta® and Symlin®) as well as oral anti-diabetic agents (Metformin, Prandase®, DPP-4 inhibitors) unless at a stable dose for 3 months and without anticipated change during the study.
- Current use of SGLT-2 inhibitors unless at a stable dose for at least 3 months, without anticipated change during the study and appropriate ketone testing is performed.
- Other serious medical illnesses which likely interfere with study participation or with the ability to complete the study by the judgment of the investigator.
- Anticipation of a significant change in exercise or diet regimen between admission and end of the study (i.e., starting or stopping an organized sport; planned significant diet change).
- Anticipated radiologic examination incompatible with CGM wear for more than 10 days between admission and end of the study (e.g., repeated MRI).
- In the opinion of the investigator, a participant who is unable or unwilling to complete the study.
- If taking medication for hypothyroidism, no change of dose (Levothyroxin) in the last 6 weeks.
Key Trial Info
Start Date :
May 2 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2025
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT05258292
Start Date
May 2 2022
End Date
May 31 2025
Last Update
August 21 2024
Active Locations (1)
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1
Institut de recherches cliniques de Montréal
Montreal, Quebec, Canada, H2W 1R7