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

NCT05258292 | Recruiting

• 1 other identifier: 2022-1165
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

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 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

Type1diabetes

Keywords

Menstrual cycle; Continuous glucose monitoring; Insulin dose; Physical activity; Food intake

Outcome Measures

Primary Outcomes (6)

• Mean glucose levels during the early follicular phase

  Day 1 to 5 of the menstrual cycle

• Mean glucose levels during the mid-late follicular phase

  Day 6 until 2 days prior to ovulation

• Mean glucose levels during the periovulation phase

  Ovulation plus/minus 1 day

• Mean glucose levels during the early luteal phase

  Day 2 to 4 after ovulation

• Mean glucose levels during the mid-luteal phase

  Day 5 to 9 after ovulation

• Mean glucose levels during the late luteal phase

  Day 10 after ovulation until the first day of the next menstrual cycle

Secondary Outcomes (78)

• Percentage of time of glucose levels between 3.9 and 7.8 mmol/L

  Day 1 to 5 of the menstrual cycle

• Percentage of time of glucose levels between 3.9 and 7.8 mmol/L

  Day 6 until 2 days prior to ovulation

• Percentage of time of glucose levels between 3.9 and 7.8 mmol/L

  Ovulation plus/minus 1 day

• Percentage of time of glucose levels between 3.9 and 7.8 mmol/L

  Day 2 to 4 after ovulation

• Percentage of time of glucose levels between 3.9 and 7.8 mmol/L

  Day 5 to 9 after ovulation

Study Arms (1)

Women with type 1 diabetes

Device: Continuous glucose monitoring; Drug: Insulin; Other: Premenstrual symptoms; Other: Ovulation kits; Device: Fitbit Inspire 2; Other: Keenoa; Other: Menstrual cycle

Interventions

Fitbit Inspire 2 DEVICE

Physical activity will be assessed using the Fitbit Inspire 2

Women with type 1 diabetes

Keenoa OTHER

Food intake will be assessed using the Keenoa phone application

Women with type 1 diabetes

Menstrual cycle OTHER

The application My Calendar will be used to record information on the menstrual cycle

Women with type 1 diabetes

Continuous glucose monitoring DEVICE

Glucose levels will be measured using continuous glucose monitoring

Women with type 1 diabetes

Insulin DRUG

Insulin doses will be retrieved from insulin pump reports (for insulin pump users) or journals for (for multiple daily injections users)

Women with type 1 diabetes

Premenstrual symptoms OTHER

Premenstrual symptoms will be assessed using the Premenstrual symptoms screening tool

Women with type 1 diabetes

Ovulation kits OTHER

Ovulation testing will be done using ovulation kits

Women with type 1 diabetes

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women aged 18 to 50 living with type 1 diabetes.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut de Recherches Cliniques de Montreal: lead

Study Sites (1)

Institut de recherches cliniques de Montréal

Montreal, Quebec, H2W 1R7, Canada

RECRUITING

MeSH Terms

Conditions

Motor Activity

Interventions

Continuous Glucose Monitoring; Insulin; Menstrual Cycle

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Rémi Rabasa-Lhoret

  Institut de recherches cliniques de Montréal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Bonhoure

CONTACT

514-987-5500; anne.bonhoure@ircm.qc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: February 28, 2022
• Study Start: May 2, 2022
• Primary Completion: April 1, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)