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.
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.
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).
Women aged 18 to 50 living with type 1 diabetes.
Cohort
Other
Continuous glucose monitoring
DeviceGlucose levels will be measured using continuous glucose monitoring
Insulin
DrugInsulin doses will be retrieved from insulin pump reports (for insulin pump users) or journals for (for multiple daily injections users)
Premenstrual symptoms
Other interventionPremenstrual symptoms will be assessed using the Premenstrual symptoms screening tool
Ovulation kits
Other interventionOvulation testing will be done using ovulation kits
Fitbit Inspire 2
DevicePhysical activity will be assessed using the Fitbit Inspire 2
Keenoa
Other interventionFood intake will be assessed using the Keenoa phone application
Menstrual cycle
Other interventionThe application My Calendar will be used to record information on the menstrual cycle
Mean glucose levels during the early follicular phase
Mean glucose levels during the mid-late follicular phase
Mean glucose levels during the periovulation phase
Mean glucose levels during the early luteal phase
Percentage of time of glucose levels between 3.9 and 7.8 mmol/L
Percentage of time of glucose levels between 3.9 and 7.8 mmol/L
Percentage of time of glucose levels between 3.9 and 7.8 mmol/L
Percentage of time of glucose levels between 3.9 and 7.8 mmol/L
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