Glycemic Variations During the Menstrual Cycle in Women With Type 1 Diabetes

ConditionType1diabetes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorInstitut de Recherches Cliniques de Montreal

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

Treatment groups

86 Participants
are divided into 1 treatment group