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

NCT ID: NCT05258292

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 86 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-02
• Study Completion Date: 2025-05-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Women with type 1 diabetes

Continuous glucose monitoring

Intervention Type: DEVICE

Glucose levels will be measured using continuous glucose monitoring

Insulin

Intervention Type: DRUG

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

Premenstrual symptoms

Intervention Type: OTHER

Premenstrual symptoms will be assessed using the Premenstrual symptoms screening tool

Ovulation kits

Intervention Type: OTHER

Ovulation testing will be done using ovulation kits

Fitbit Inspire 2

Intervention Type: DEVICE

Physical activity will be assessed using the Fitbit Inspire 2

Keenoa

Intervention Type: OTHER

Food intake will be assessed using the Keenoa phone application

Menstrual cycle

Intervention Type: OTHER

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

Interventions

Continuous glucose monitoring

Glucose levels will be measured using continuous glucose monitoring

Intervention Type: DEVICE

Insulin

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

Intervention Type: DRUG

Premenstrual symptoms

Premenstrual symptoms will be assessed using the Premenstrual symptoms screening tool

Intervention Type: OTHER

Ovulation kits

Ovulation testing will be done using ovulation kits

Intervention Type: OTHER

Fitbit Inspire 2

Physical activity will be assessed using the Fitbit Inspire 2

Intervention Type: DEVICE

Keenoa

Food intake will be assessed using the Keenoa phone application

Intervention Type: OTHER

Menstrual cycle

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Females aged 18 to 50 living in Canada.

2. Clinical diagnosis of type 1 diabetes or latent autoimmune diabetes in adults (LADA) for at least one year.

3. Using insulin pump therapy, multiple daily injections or automated insulin delivery systems for at least 3 months.

4. Using a continuous glucose monitoring (CGM) system.

5. Having at least one menses in the last 40 days.

6. Accepting to share CGM data with the research team and if applicable insulin pump data.This access will be limited to the study period.

7. Having a smartphone or tablet to follow menstrual cycles.

8. Stable weight (less than 5% variation in the last 3 months).

Exclusion Criteria

1. Using a hormonal contraception method that eliminates menses (Depo Provera, progestin intrauterine device, extented-cycle regimen with birth control pill)

2. Using regular insulin (Entuzity U500, Novolin ge Toronto or Humulin R).

3. 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.

4. Recent (< 6 months) acute macrovascular event (e.g., acute coronary syndrome or cardiac surgery).

5. 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.

6. Anticipated change in contraception method or plan to begin or stop a contraceptive method.

7. Anticipated need to use acetaminophen during the study period at a dose above 1g every 6 hours.

8. Pregnancy (ongoing or current attempt to become pregnant)

9. Breastfeeding

10. Uncontrolled thyroid disease (TSH should be in target range and treatment stable for at least 6 weeks).

11. Severe hypoglycemic episode within two weeks of screening

12. Severe hyperglycemic episodes requiring hospitalization in the last 3 months.

13. Current use of glucocorticoid medication (except low stable dose and inhaled steroids and stable adrenal insufficiency treatment e.g., Cortef®)

14. 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.

15. 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.

16. Other serious medical illnesses which likely interfere with study participation or with the ability to complete the study by the judgment of the investigator.

17. 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).

18. Anticipated radiologic examination incompatible with CGM wear for more than 10 days between admission and end of the study (e.g., repeated MRI).

19. In the opinion of the investigator, a participant who is unable or unwilling to complete the study.

20. If taking medication for hypothyroidism, no change of dose (Levothyroxin) in the last 6 weeks.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut de Recherches Cliniques de Montreal

OTHER

Sponsor Role: lead

Responsible Party

Rémi Rabasa-Lhoret

Full professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rémi Rabasa-Lhoret

Role: PRINCIPAL_INVESTIGATOR

Institut de recherches cliniques de Montréal

Locations

Institut de recherches cliniques de Montréal

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Anne Bonhoure

Role: CONTACT

anne.bonhoure@ircm.qc.ca

514-987-5500 ext. 3238

Facility Contacts

Anne Bonhoure

Role: primary

anne.bonhoure@ircm.qc.ca

514-987-5500 ext. 3238

Other Identifiers

2022-1165

Identifier Type: -

Identifier Source: org_study_id