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

Type1diabetes Clinical Trial

— GLYMETY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05258292
• Other study ID #: 2022-1165
• Status: Recruiting
• Start date: May 2, 2022
• Est. completion date: May 31, 2024

Study information

• Verified date: August 2023
• Source: Institut de Recherches Cliniques de Montreal
• Contact: Anne Bonhoure
• Phone: 514-987-5500
• Email: anne.bonhoure[@]ircm.qc.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: May 31, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Females aged 18 to 50.

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.

7. Living in the province of Quebec, Canada.

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

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type1diabetes

Intervention

Device:
• Continuous glucose monitoring
Glucose levels will be measured using continuous glucose monitoring

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

Other:
• Premenstrual symptoms
Premenstrual symptoms will be assessed using the Premenstrual symptoms screening tool
• Ovulation kits
Ovulation testing will be done using ovulation kits

Device:
• Fitbit Inspire 2
Physical activity will be assessed using the Fitbit Inspire 2

Other:
• Keenoa
Food intake will be assessed using the Keenoa phone application
• Menstrual cycle
The application My Calendar will be used to record information on the menstrual cycle

Locations

Country	Name	City	State
Canada	Institut de recherches cliniques de Montréal	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Recherches Cliniques de Montreal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean glucose levels during the early follicular phase		Day 1 to 5 of the menstrual cycle
Primary	Mean glucose levels during the mid-late follicular phase		Day 6 until 2 days prior to ovulation
Primary	Mean glucose levels during the periovulation phase		Ovulation plus/minus 1 day
Primary	Mean glucose levels during the early luteal phase		Day 2 to 4 after ovulation
Primary	Mean glucose levels during the mid-luteal phase		Day 5 to 9 after ovulation
Primary	Mean glucose levels during the late luteal phase		Day 10 after ovulation until the first day of the next menstrual cycle
Secondary	Percentage of time of glucose levels between 3.9 and 7.8 mmol/L		Day 1 to 5 of the menstrual cycle
Secondary	Percentage of time of glucose levels between 3.9 and 7.8 mmol/L		Day 6 until 2 days prior to ovulation
Secondary	Percentage of time of glucose levels between 3.9 and 7.8 mmol/L		Ovulation plus/minus 1 day
Secondary	Percentage of time of glucose levels between 3.9 and 7.8 mmol/L		Day 2 to 4 after ovulation
Secondary	Percentage of time of glucose levels between 3.9 and 7.8 mmol/L		Day 5 to 9 after ovulation
Secondary	Percentage of time of glucose levels between 3.9 and 7.8 mmol/L		Day 10 after ovulation until the first day of the next menstrual cycle
Secondary	Percentage of time of glucose levels between 3.9 and 10.0 mmol/L		Day 1 to 5 of the menstrual cycle
Secondary	Percentage of time of glucose levels between 3.9 and 10.0 mmol/L		Day 6 until 2 days prior to ovulation
Secondary	Percentage of time of glucose levels between 3.9 and 10.0 mmol/L		Ovulation plus/minus 1 day
Secondary	Percentage of time of glucose levels between 3.9 and 10.0 mmol/L		Day 2 to 4 after ovulation
Secondary	Percentage of time of glucose levels between 3.9 and 10.0 mmol/L		Day 5 to 9 after ovulation
Secondary	Percentage of time of glucose levels between 3.9 and 10.0 mmol/L		Day 10 after ovulation until the first day of the next menstrual cycle
Secondary	Percentage of time of glucose levels below 3.9 mmol/L		Day 1 to 5 of the menstrual cycle
Secondary	Percentage of time of glucose levels below 3.9 mmol/L		Day 6 until 2 days prior to ovulation
Secondary	Percentage of time of glucose levels below 3.9 mmol/L		Ovulation plus/minus 1 day
Secondary	Percentage of time of glucose levels below 3.9 mmol/L		Day 2 to 4 after ovulation
Secondary	Percentage of time of glucose levels below 3.9 mmol/L		Day 5 to 9 after ovulation
Secondary	Percentage of time of glucose levels below 3.9 mmol/L		Day 10 after ovulation until the first day of the next menstrual cycle
Secondary	Percentage of time of glucose levels below 3.0 mmol/L		Day 1 to 5 of the menstrual cycle
Secondary	Percentage of time of glucose levels below 3.0 mmol/L		Day 6 until 2 days prior to ovulation
Secondary	Percentage of time of glucose levels below 3.0 mmol/L		Ovulation plus/minus 1 day
Secondary	Percentage of time of glucose levels below 3.0 mmol/L		Day 2 to 4 after ovulation
Secondary	Percentage of time of glucose levels below 3.0 mmol/L		Day 5 to 9 after ovulation
Secondary	Percentage of time of glucose levels below 3.0 mmol/L		Day 10 after ovulation until the first day of the next menstrual cycle
Secondary	Percentage of time of glucose levels above 10.0 mmol/L		Day 1 to 5 of the menstrual cycle
Secondary	Percentage of time of glucose levels above 10.0 mmol/L		Day 6 until 2 days prior to ovulation
Secondary	Percentage of time of glucose levels above 10.0 mmol/L		Ovulation plus/minus 1 day
Secondary	Percentage of time of glucose levels above 10.0 mmol/L		Day 2 to 4 after ovulation
Secondary	Percentage of time of glucose levels above 10.0 mmol/L		Day 5 to 9 after ovulation
Secondary	Percentage of time of glucose levels above 10.0 mmol/L		Day 10 after ovulation until the first day of the next menstrual cycle
Secondary	Percentage of time of glucose levels above 13.9 mmol/L		Day 1 to 5 of the menstrual cycle
Secondary	Percentage of time of glucose levels above 13.9 mmol/L		Day 6 until 2 days prior to ovulation
Secondary	Percentage of time of glucose levels above 13.9 mmol/L		Ovulation plus/minus 1 day
Secondary	Percentage of time of glucose levels above 13.9 mmol/L		Day 2 to 4 after ovulation
Secondary	Percentage of time of glucose levels above 13.9 mmol/L		Day 5 to 9 after ovulation
Secondary	Percentage of time of glucose levels above 13.9 mmol/L		Day 10 after ovulation until the first day of the next menstrual cycle
Secondary	Standard deviation of glucose levels		Day 1 to 5 of the menstrual cycle
Secondary	Standard deviation of glucose levels		Day 6 until 2 days prior to ovulation
Secondary	Standard deviation of glucose levels		Ovulation plus/minus 1 day
Secondary	Standard deviation of glucose levels		Day 2 to 4 after ovulation
Secondary	Standard deviation of glucose levels		Day 5 to 9 after ovulation
Secondary	Standard deviation of glucose levels		Day 10 after ovulation until the first day of the next menstrual cycle
Secondary	Coefficient of variance of glucose levels		Day 1 to 5 of the menstrual cycle
Secondary	Coefficient of variance of glucose levels		Day 6 until 2 days prior to ovulation
Secondary	Coefficient of variance of glucose levels		Ovulation plus/minus 1 day
Secondary	Coefficient of variance of glucose levels		Day 2 to 4 after ovulation
Secondary	Coefficient of variance of glucose levels		Day 5 to 9 after ovulation
Secondary	Coefficient of variance of glucose levels		Day 10 after ovulation until the first day of the next menstrual cycle
Secondary	Low blood glucose index		Day 1 to 5 of the menstrual cycle
Secondary	Low blood glucose index		Day 6 until 2 days prior to ovulation
Secondary	Low blood glucose index		Ovulation plus/minus 1 day
Secondary	Low blood glucose index		Day 2 to 4 after ovulation
Secondary	Low blood glucose index		Day 5 to 9 after ovulation
Secondary	Low blood glucose index		Day 10 after ovulation until the first day of the next menstrual cycle
Secondary	High blood glucose index		Day 1 to 5 of the menstrual cycle
Secondary	High blood glucose index		Day 6 until 2 days prior to ovulation
Secondary	High blood glucose index		Ovulation plus/minus 1 day
Secondary	High blood glucose index		Day 2 to 4 after ovulation
Secondary	High blood glucose index		Day 5 to 9 after ovulation
Secondary	High blood glucose index		Day 10 after ovulation until the first day of the next menstrual cycle
Secondary	Standard deviation of insulin delivery		Day 1 to 5 of the menstrual cycle
Secondary	Standard deviation of insulin delivery		Day 6 until 2 days prior to ovulation
Secondary	Standard deviation of insulin delivery		Ovulation plus/minus 1 day
Secondary	Standard deviation of insulin delivery		Day 2 to 4 after ovulation
Secondary	Standard deviation of insulin delivery		Day 5 to 9 after ovulation
Secondary	Standard deviation of insulin delivery		Day 10 after ovulation until the first day of the next menstrual cycle
Secondary	Coefficient of variance of insulin delivery		Day 1 to 5 of the menstrual cycle
Secondary	Coefficient of variance of insulin delivery		Day 6 until 2 days prior to ovulation
Secondary	Coefficient of variance of insulin delivery		Ovulation plus/minus 1 day
Secondary	Coefficient of variance of insulin delivery		Day 2 to 4 after ovulation
Secondary	Coefficient of variance of insulin delivery		Day 5 to 9 after ovulation
Secondary	Coefficient of variance of insulin delivery		Day 10 after ovulation until the first day of the next menstrual cycle
Secondary	Total insulin delivery		Day 1 to 5 of the menstrual cycle
Secondary	Total insulin delivery		Day 6 until 2 days prior to ovulation
Secondary	Total insulin delivery		Ovulation plus/minus 1 day
Secondary	Total insulin delivery		Day 2 to 4 after ovulation
Secondary	Total insulin delivery		Day 5 to 9 after ovulation
Secondary	Total insulin delivery		Day 10 after ovulation until the first day of the next menstrual cycle