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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05258292
Recruitment Status : Recruiting
First Posted : February 28, 2022
Last Update Posted : July 28, 2022
Sponsor:
Information provided by (Responsible Party):
Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal

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.


Condition or disease Intervention/treatment
Type1diabetes Device: Continuous glucose monitoring Drug: Insulin Other: Premenstrual symptoms Other: Ovulation kits Device: Fitbit Inspire 2 Other: Keenoa Other: Menstrual cycle

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Study Type : Observational
Estimated Enrollment : 86 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Glycemic Variations During the Menstrual Cycle in Women With Type 1 Diabetes: the GLYMETY Study
Actual Study Start Date : May 2, 2022
Estimated Primary Completion Date : April 1, 2024
Estimated Study Completion Date : May 31, 2024

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Women with type 1 diabetes 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

Other: 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

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




Primary Outcome Measures :
  1. Mean glucose levels during the early follicular phase [ Time Frame: Day 1 to 5 of the menstrual cycle ]
  2. Mean glucose levels during the mid-late follicular phase [ Time Frame: Day 6 until 2 days prior to ovulation ]
  3. Mean glucose levels during the periovulation phase [ Time Frame: Ovulation plus/minus 1 day ]
  4. Mean glucose levels during the early luteal phase [ Time Frame: Day 2 to 4 after ovulation ]
  5. Mean glucose levels during the mid-luteal phase [ Time Frame: Day 5 to 9 after ovulation ]
  6. Mean glucose levels during the late luteal phase [ Time Frame: Day 10 after ovulation until the first day of the next menstrual cycle ]

Secondary Outcome Measures :
  1. Percentage of time of glucose levels between 3.9 and 7.8 mmol/L [ Time Frame: Day 1 to 5 of the menstrual cycle ]
  2. Percentage of time of glucose levels between 3.9 and 7.8 mmol/L [ Time Frame: Day 6 until 2 days prior to ovulation ]
  3. Percentage of time of glucose levels between 3.9 and 7.8 mmol/L [ Time Frame: Ovulation plus/minus 1 day ]
  4. Percentage of time of glucose levels between 3.9 and 7.8 mmol/L [ Time Frame: Day 2 to 4 after ovulation ]
  5. Percentage of time of glucose levels between 3.9 and 7.8 mmol/L [ Time Frame: Day 5 to 9 after ovulation ]
  6. 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 ]
  7. Percentage of time of glucose levels between 3.9 and 10.0 mmol/L [ Time Frame: Day 1 to 5 of the menstrual cycle ]
  8. Percentage of time of glucose levels between 3.9 and 10.0 mmol/L [ Time Frame: Day 6 until 2 days prior to ovulation ]
  9. Percentage of time of glucose levels between 3.9 and 10.0 mmol/L [ Time Frame: Ovulation plus/minus 1 day ]
  10. Percentage of time of glucose levels between 3.9 and 10.0 mmol/L [ Time Frame: Day 2 to 4 after ovulation ]
  11. Percentage of time of glucose levels between 3.9 and 10.0 mmol/L [ Time Frame: Day 5 to 9 after ovulation ]
  12. 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 ]
  13. Percentage of time of glucose levels below 3.9 mmol/L [ Time Frame: Day 1 to 5 of the menstrual cycle ]
  14. Percentage of time of glucose levels below 3.9 mmol/L [ Time Frame: Day 6 until 2 days prior to ovulation ]
  15. Percentage of time of glucose levels below 3.9 mmol/L [ Time Frame: Ovulation plus/minus 1 day ]
  16. Percentage of time of glucose levels below 3.9 mmol/L [ Time Frame: Day 2 to 4 after ovulation ]
  17. Percentage of time of glucose levels below 3.9 mmol/L [ Time Frame: Day 5 to 9 after ovulation ]
  18. 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 ]
  19. Percentage of time of glucose levels below 3.0 mmol/L [ Time Frame: Day 1 to 5 of the menstrual cycle ]
  20. Percentage of time of glucose levels below 3.0 mmol/L [ Time Frame: Day 6 until 2 days prior to ovulation ]
  21. Percentage of time of glucose levels below 3.0 mmol/L [ Time Frame: Ovulation plus/minus 1 day ]
  22. Percentage of time of glucose levels below 3.0 mmol/L [ Time Frame: Day 2 to 4 after ovulation ]
  23. Percentage of time of glucose levels below 3.0 mmol/L [ Time Frame: Day 5 to 9 after ovulation ]
  24. 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 ]
  25. Percentage of time of glucose levels above 10.0 mmol/L [ Time Frame: Day 1 to 5 of the menstrual cycle ]
  26. Percentage of time of glucose levels above 10.0 mmol/L [ Time Frame: Day 6 until 2 days prior to ovulation ]
  27. Percentage of time of glucose levels above 10.0 mmol/L [ Time Frame: Ovulation plus/minus 1 day ]
  28. Percentage of time of glucose levels above 10.0 mmol/L [ Time Frame: Day 2 to 4 after ovulation ]
  29. Percentage of time of glucose levels above 10.0 mmol/L [ Time Frame: Day 5 to 9 after ovulation ]
  30. 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 ]
  31. Percentage of time of glucose levels above 13.9 mmol/L [ Time Frame: Day 1 to 5 of the menstrual cycle ]
  32. Percentage of time of glucose levels above 13.9 mmol/L [ Time Frame: Day 6 until 2 days prior to ovulation ]
  33. Percentage of time of glucose levels above 13.9 mmol/L [ Time Frame: Ovulation plus/minus 1 day ]
  34. Percentage of time of glucose levels above 13.9 mmol/L [ Time Frame: Day 2 to 4 after ovulation ]
  35. Percentage of time of glucose levels above 13.9 mmol/L [ Time Frame: Day 5 to 9 after ovulation ]
  36. 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 ]
  37. Standard deviation of glucose levels [ Time Frame: Day 1 to 5 of the menstrual cycle ]
  38. Standard deviation of glucose levels [ Time Frame: Day 6 until 2 days prior to ovulation ]
  39. Standard deviation of glucose levels [ Time Frame: Ovulation plus/minus 1 day ]
  40. Standard deviation of glucose levels [ Time Frame: Day 2 to 4 after ovulation ]
  41. Standard deviation of glucose levels [ Time Frame: Day 5 to 9 after ovulation ]
  42. Standard deviation of glucose levels [ Time Frame: Day 10 after ovulation until the first day of the next menstrual cycle ]
  43. Coefficient of variance of glucose levels [ Time Frame: Day 1 to 5 of the menstrual cycle ]
  44. Coefficient of variance of glucose levels [ Time Frame: Day 6 until 2 days prior to ovulation ]
  45. Coefficient of variance of glucose levels [ Time Frame: Ovulation plus/minus 1 day ]
  46. Coefficient of variance of glucose levels [ Time Frame: Day 2 to 4 after ovulation ]
  47. Coefficient of variance of glucose levels [ Time Frame: Day 5 to 9 after ovulation ]
  48. Coefficient of variance of glucose levels [ Time Frame: Day 10 after ovulation until the first day of the next menstrual cycle ]
  49. Low blood glucose index [ Time Frame: Day 1 to 5 of the menstrual cycle ]
  50. Low blood glucose index [ Time Frame: Day 6 until 2 days prior to ovulation ]
  51. Low blood glucose index [ Time Frame: Ovulation plus/minus 1 day ]
  52. Low blood glucose index [ Time Frame: Day 2 to 4 after ovulation ]
  53. Low blood glucose index [ Time Frame: Day 5 to 9 after ovulation ]
  54. Low blood glucose index [ Time Frame: Day 10 after ovulation until the first day of the next menstrual cycle ]
  55. High blood glucose index [ Time Frame: Day 1 to 5 of the menstrual cycle ]
  56. High blood glucose index [ Time Frame: Day 6 until 2 days prior to ovulation ]
  57. High blood glucose index [ Time Frame: Ovulation plus/minus 1 day ]
  58. High blood glucose index [ Time Frame: Day 2 to 4 after ovulation ]
  59. High blood glucose index [ Time Frame: Day 5 to 9 after ovulation ]
  60. High blood glucose index [ Time Frame: Day 10 after ovulation until the first day of the next menstrual cycle ]
  61. Standard deviation of insulin delivery [ Time Frame: Day 1 to 5 of the menstrual cycle ]
  62. Standard deviation of insulin delivery [ Time Frame: Day 6 until 2 days prior to ovulation ]
  63. Standard deviation of insulin delivery [ Time Frame: Ovulation plus/minus 1 day ]
  64. Standard deviation of insulin delivery [ Time Frame: Day 2 to 4 after ovulation ]
  65. Standard deviation of insulin delivery [ Time Frame: Day 5 to 9 after ovulation ]
  66. Standard deviation of insulin delivery [ Time Frame: Day 10 after ovulation until the first day of the next menstrual cycle ]
  67. Coefficient of variance of insulin delivery [ Time Frame: Day 1 to 5 of the menstrual cycle ]
  68. Coefficient of variance of insulin delivery [ Time Frame: Day 6 until 2 days prior to ovulation ]
  69. Coefficient of variance of insulin delivery [ Time Frame: Ovulation plus/minus 1 day ]
  70. Coefficient of variance of insulin delivery [ Time Frame: Day 2 to 4 after ovulation ]
  71. Coefficient of variance of insulin delivery [ Time Frame: Day 5 to 9 after ovulation ]
  72. Coefficient of variance of insulin delivery [ Time Frame: Day 10 after ovulation until the first day of the next menstrual cycle ]
  73. Total insulin delivery [ Time Frame: Day 1 to 5 of the menstrual cycle ]
  74. Total insulin delivery [ Time Frame: Day 6 until 2 days prior to ovulation ]
  75. Total insulin delivery [ Time Frame: Ovulation plus/minus 1 day ]
  76. Total insulin delivery [ Time Frame: Day 2 to 4 after ovulation ]
  77. Total insulin delivery [ Time Frame: Day 5 to 9 after ovulation ]
  78. Total insulin delivery [ Time Frame: Day 10 after ovulation until the first day of the next menstrual cycle ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women aged 18 to 50 living with type 1 diabetes.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05258292


Contacts
Layout table for location contacts
Contact: Anne Bonhoure 514-987-5500 ext 3238 anne.bonhoure@ircm.qc.ca

Locations
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Canada, Quebec
Institut de recherches cliniques de Montréal Recruiting
Montreal, Quebec, Canada, H2W 1R7
Contact: Anne Bonhoure    514-987-5500 ext 3238    anne.bonhoure@ircm.qc.ca   
Principal Investigator: Rémi Rabasa-Lhoret         
Sponsors and Collaborators
Institut de Recherches Cliniques de Montreal
Investigators
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Principal Investigator: Rémi Rabasa-Lhoret Institut de recherches cliniques de Montréal
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Responsible Party: Rémi Rabasa-Lhoret, Full professor, Institut de Recherches Cliniques de Montreal
ClinicalTrials.gov Identifier: NCT05258292    
Other Study ID Numbers: 2022-1165
First Posted: February 28, 2022    Key Record Dates
Last Update Posted: July 28, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal:
Menstrual cycle
Continuous glucose monitoring
Insulin dose
Physical activity
Food intake
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs