NCT05258292 - Glycemic Variations During the Menstrual Cycle in Women With Type 1 Diabetes | Crick

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Mean glucose levels during the early follicular phase

Time frame: Day 1 to 5 of the menstrual cycle

Mean glucose levels during the mid-late follicular phase

Time frame: Day 6 until 2 days prior to ovulation

Mean glucose levels during the periovulation phase

Time frame: Ovulation plus/minus 1 day

Mean glucose levels during the early luteal phase

Time frame: Day 2 to 4 after ovulation

Mean glucose levels during the mid-luteal phase

Time frame: Day 5 to 9 after ovulation

Mean glucose levels during the late luteal phase

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

Secondary Outcomes

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

Time frame: Day 1 to 5 of the menstrual cycle

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

Time frame: Day 6 until 2 days prior to ovulation

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

Time frame: Ovulation plus/minus 1 day

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

Time frame: Day 2 to 4 after ovulation

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

Time frame: Day 5 to 9 after ovulation

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

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

Percentage of time of glucose levels between 3.9 and 10.0 mmol/L

Time frame: Day 1 to 5 of the menstrual cycle

Percentage of time of glucose levels between 3.9 and 10.0 mmol/L

Time frame: Day 6 until 2 days prior to ovulation

Percentage of time of glucose levels between 3.9 and 10.0 mmol/L

Time frame: Ovulation plus/minus 1 day

Percentage of time of glucose levels between 3.9 and 10.0 mmol/L

Time frame: Day 2 to 4 after ovulation

Percentage of time of glucose levels between 3.9 and 10.0 mmol/L

Time frame: Day 5 to 9 after ovulation

Percentage of time of glucose levels between 3.9 and 10.0 mmol/L

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

Percentage of time of glucose levels below 3.9 mmol/L

Time frame: Day 1 to 5 of the menstrual cycle

Percentage of time of glucose levels below 3.9 mmol/L

Time frame: Day 6 until 2 days prior to ovulation

Percentage of time of glucose levels below 3.9 mmol/L

Time frame: Ovulation plus/minus 1 day

Percentage of time of glucose levels below 3.9 mmol/L

Time frame: Day 2 to 4 after ovulation

Percentage of time of glucose levels below 3.9 mmol/L

Time frame: Day 5 to 9 after ovulation

Percentage of time of glucose levels below 3.9 mmol/L

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

Percentage of time of glucose levels below 3.0 mmol/L

Time frame: Day 1 to 5 of the menstrual cycle

Percentage of time of glucose levels below 3.0 mmol/L

Time frame: Day 6 until 2 days prior to ovulation

Percentage of time of glucose levels below 3.0 mmol/L

Time frame: Ovulation plus/minus 1 day

Percentage of time of glucose levels below 3.0 mmol/L

Time frame: Day 2 to 4 after ovulation

Percentage of time of glucose levels below 3.0 mmol/L

Time frame: Day 5 to 9 after ovulation

Percentage of time of glucose levels below 3.0 mmol/L

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

Percentage of time of glucose levels above 10.0 mmol/L

Time frame: Day 1 to 5 of the menstrual cycle

Percentage of time of glucose levels above 10.0 mmol/L

Time frame: Day 6 until 2 days prior to ovulation

Percentage of time of glucose levels above 10.0 mmol/L

Time frame: Ovulation plus/minus 1 day

Percentage of time of glucose levels above 10.0 mmol/L

Time frame: Day 2 to 4 after ovulation

Percentage of time of glucose levels above 10.0 mmol/L

Time frame: Day 5 to 9 after ovulation

Percentage of time of glucose levels above 10.0 mmol/L

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

Percentage of time of glucose levels above 13.9 mmol/L

Time frame: Day 1 to 5 of the menstrual cycle

Percentage of time of glucose levels above 13.9 mmol/L

Time frame: Day 6 until 2 days prior to ovulation

Percentage of time of glucose levels above 13.9 mmol/L

Time frame: Ovulation plus/minus 1 day

Percentage of time of glucose levels above 13.9 mmol/L

Time frame: Day 2 to 4 after ovulation

Percentage of time of glucose levels above 13.9 mmol/L

Time frame: Day 5 to 9 after ovulation

Percentage of time of glucose levels above 13.9 mmol/L

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

Standard deviation of glucose levels

Time frame: Day 1 to 5 of the menstrual cycle

Standard deviation of glucose levels

Time frame: Day 6 until 2 days prior to ovulation

Standard deviation of glucose levels

Time frame: Ovulation plus/minus 1 day

Standard deviation of glucose levels

Time frame: Day 2 to 4 after ovulation

Standard deviation of glucose levels

Time frame: Day 5 to 9 after ovulation

Standard deviation of glucose levels

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

Coefficient of variance of glucose levels

Time frame: Day 1 to 5 of the menstrual cycle

Coefficient of variance of glucose levels

Time frame: Day 6 until 2 days prior to ovulation

Coefficient of variance of glucose levels

Time frame: Ovulation plus/minus 1 day

Coefficient of variance of glucose levels

Time frame: Day 2 to 4 after ovulation

Coefficient of variance of glucose levels

Time frame: Day 5 to 9 after ovulation

Coefficient of variance of glucose levels

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

Low blood glucose index

Time frame: Day 1 to 5 of the menstrual cycle

Low blood glucose index

Time frame: Day 6 until 2 days prior to ovulation

Low blood glucose index

Time frame: Ovulation plus/minus 1 day

Low blood glucose index

Time frame: Day 2 to 4 after ovulation

Low blood glucose index

Time frame: Day 5 to 9 after ovulation

Low blood glucose index

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

High blood glucose index

Time frame: Day 1 to 5 of the menstrual cycle

High blood glucose index

Time frame: Day 6 until 2 days prior to ovulation

High blood glucose index

Time frame: Ovulation plus/minus 1 day

High blood glucose index

Time frame: Day 2 to 4 after ovulation

High blood glucose index

Time frame: Day 5 to 9 after ovulation

High blood glucose index

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

Standard deviation of insulin delivery

Time frame: Day 1 to 5 of the menstrual cycle

Standard deviation of insulin delivery

Time frame: Day 6 until 2 days prior to ovulation

Standard deviation of insulin delivery

Time frame: Ovulation plus/minus 1 day

Standard deviation of insulin delivery

Time frame: Day 2 to 4 after ovulation

Standard deviation of insulin delivery

Time frame: Day 5 to 9 after ovulation

Standard deviation of insulin delivery

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

Coefficient of variance of insulin delivery

Time frame: Day 1 to 5 of the menstrual cycle

Coefficient of variance of insulin delivery

Time frame: Day 6 until 2 days prior to ovulation

Coefficient of variance of insulin delivery

Time frame: Ovulation plus/minus 1 day

Coefficient of variance of insulin delivery

Time frame: Day 2 to 4 after ovulation

Coefficient of variance of insulin delivery

Time frame: Day 5 to 9 after ovulation

Coefficient of variance of insulin delivery

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

Total insulin delivery

Time frame: Day 1 to 5 of the menstrual cycle

Total insulin delivery

Time frame: Day 6 until 2 days prior to ovulation

Total insulin delivery

Time frame: Ovulation plus/minus 1 day

Total insulin delivery

Time frame: Day 2 to 4 after ovulation

Total insulin delivery

Time frame: Day 5 to 9 after ovulation

Total insulin delivery

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts