About this trial
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
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Continuous glucose monitoring
- Insulin
- Premenstrual symptoms
- Ovulation kits
- Fitbit Inspire 2
- Keenoa
- Menstrual cycle