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Type1diabetesGLYMETYNCT05258292

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

An observational study of Type1diabetes, run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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). Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Type1diabetes
What is being tested?
Continuous glucose monitoring, Insulin and Premenstrual symptoms
How many people
86 participants
Where
1 siteCanada
Study dates
2 May 2022to 31 May 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: Women aged 18 to 50 living with type 1 diabetes.

Who may be able to join

  • 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).

Who cannot join

  • 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.
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  • 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.
  • Other serious medical illnesses which likely interfere with study participation or with the ability to complete the study by the judgment of the investigator.
  • 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).
  • Anticipated radiologic examination incompatible with CGM wear for more than 10 days between admission and end of the study (e.g., repeated MRI).
  • In the opinion of the investigator, a participant who is unable or unwilling to complete the study.
  • If taking medication for hypothyroidism, no change of dose (Levothyroxin) in the last 6 weeks.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Anne Bonhoure contact

514-987-5500 ext. 3238

anne.bonhoure@ircm.qc.ca

Canada1 site, 1 recruiting

  • Institut de recherches cliniques de Montréal

    Montreal, Quebec, H2W 1R7

    Anne Bonhoure, 514-987-5500 ext. 3238, anne.bonhoure@ircm.qc.ca

    Rémi Rabasa-Lhoret

    Recruiting

Other trials in Canada

About this study

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

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
Being tested
Continuous glucose monitoring, Insulin, Premenstrual symptoms, Ovulation kits, Fitbit Inspire 2
Keywords
Menstrual cycle, Continuous glucose monitoring, Insulin dose, Physical activity, Food intake
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Continuous glucose monitoringDevice

    Glucose levels will be measured using continuous glucose monitoring

  • InsulinDrug

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

  • Premenstrual symptomsOther

    Premenstrual symptoms will be assessed using the Premenstrual symptoms screening tool

  • Ovulation kitsOther

    Ovulation testing will be done using ovulation kits

  • Fitbit Inspire 2Device

    Physical activity will be assessed using the Fitbit Inspire 2

  • KeenoaOther

    Food intake will be assessed using the Keenoa phone application

  • Menstrual cycleOther

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

Study groups in NCT05258292
Study groupRoleWhat they receive
Women with type 1 diabetesNot described
Receives: Device: Continuous glucose monitoring; Drug: Insulin; Other: Premenstrual symptoms; Other: Ovulation kits; Device: Fitbit Inspire 2; Other: Keenoa; Other: Menstrual cycle

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean glucose levels during the early follicular phase

    Measured: Day 1 to 5 of the menstrual cycle

  2. Mean glucose levels during the mid-late follicular phase

    Measured: Day 6 until 2 days prior to ovulation

  3. Mean glucose levels during the periovulation phase

    Measured: Ovulation plus/minus 1 day

  4. Mean glucose levels during the early luteal phase

    Measured: Day 2 to 4 after ovulation

  5. Mean glucose levels during the mid-luteal phase

    Measured: Day 5 to 9 after ovulation

  6. Mean glucose levels during the late luteal phase

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

Secondary outcomes (78)

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

    Measured: Day 1 to 5 of the menstrual cycle

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

    Measured: Day 6 until 2 days prior to ovulation

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

    Measured: Ovulation plus/minus 1 day

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

    Measured: Day 2 to 4 after ovulation

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

    Measured: Day 5 to 9 after ovulation

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

    Measured: 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

    Measured: Day 1 to 5 of the menstrual cycle

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

    Measured: Day 6 until 2 days prior to ovulation

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

    Measured: Ovulation plus/minus 1 day

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

    Measured: Day 2 to 4 after ovulation

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

    Measured: Day 5 to 9 after ovulation

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

    Measured: 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

    Measured: Day 1 to 5 of the menstrual cycle

  14. Percentage of time of glucose levels below 3.9 mmol/L

    Measured: Day 6 until 2 days prior to ovulation

  15. Percentage of time of glucose levels below 3.9 mmol/L

    Measured: Ovulation plus/minus 1 day

  16. Percentage of time of glucose levels below 3.9 mmol/L

    Measured: Day 2 to 4 after ovulation

  17. Percentage of time of glucose levels below 3.9 mmol/L

    Measured: Day 5 to 9 after ovulation

  18. Percentage of time of glucose levels below 3.9 mmol/L

    Measured: 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

    Measured: Day 1 to 5 of the menstrual cycle

  20. Percentage of time of glucose levels below 3.0 mmol/L

    Measured: Day 6 until 2 days prior to ovulation

  21. Percentage of time of glucose levels below 3.0 mmol/L

    Measured: Ovulation plus/minus 1 day

  22. Percentage of time of glucose levels below 3.0 mmol/L

    Measured: Day 2 to 4 after ovulation

  23. Percentage of time of glucose levels below 3.0 mmol/L

    Measured: Day 5 to 9 after ovulation

  24. Percentage of time of glucose levels below 3.0 mmol/L

    Measured: 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

    Measured: Day 1 to 5 of the menstrual cycle

  26. Percentage of time of glucose levels above 10.0 mmol/L

    Measured: Day 6 until 2 days prior to ovulation

  27. Percentage of time of glucose levels above 10.0 mmol/L

    Measured: Ovulation plus/minus 1 day

  28. Percentage of time of glucose levels above 10.0 mmol/L

    Measured: Day 2 to 4 after ovulation

  29. Percentage of time of glucose levels above 10.0 mmol/L

    Measured: Day 5 to 9 after ovulation

  30. Percentage of time of glucose levels above 10.0 mmol/L

    Measured: 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

    Measured: Day 1 to 5 of the menstrual cycle

  32. Percentage of time of glucose levels above 13.9 mmol/L

    Measured: Day 6 until 2 days prior to ovulation

  33. Percentage of time of glucose levels above 13.9 mmol/L

    Measured: Ovulation plus/minus 1 day

  34. Percentage of time of glucose levels above 13.9 mmol/L

    Measured: Day 2 to 4 after ovulation

  35. Percentage of time of glucose levels above 13.9 mmol/L

    Measured: Day 5 to 9 after ovulation

  36. Percentage of time of glucose levels above 13.9 mmol/L

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

  37. Standard deviation of glucose levels

    Measured: Day 1 to 5 of the menstrual cycle

  38. Standard deviation of glucose levels

    Measured: Day 6 until 2 days prior to ovulation

  39. Standard deviation of glucose levels

    Measured: Ovulation plus/minus 1 day

  40. Standard deviation of glucose levels

    Measured: Day 2 to 4 after ovulation

  41. Standard deviation of glucose levels

    Measured: Day 5 to 9 after ovulation

  42. Standard deviation of glucose levels

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

  43. Coefficient of variance of glucose levels

    Measured: Day 1 to 5 of the menstrual cycle

  44. Coefficient of variance of glucose levels

    Measured: Day 6 until 2 days prior to ovulation

  45. Coefficient of variance of glucose levels

    Measured: Ovulation plus/minus 1 day

  46. Coefficient of variance of glucose levels

    Measured: Day 2 to 4 after ovulation

  47. Coefficient of variance of glucose levels

    Measured: Day 5 to 9 after ovulation

  48. Coefficient of variance of glucose levels

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

  49. Low blood glucose index

    Measured: Day 1 to 5 of the menstrual cycle

  50. Low blood glucose index

    Measured: Day 6 until 2 days prior to ovulation

  51. Low blood glucose index

    Measured: Ovulation plus/minus 1 day

  52. Low blood glucose index

    Measured: Day 2 to 4 after ovulation

  53. Low blood glucose index

    Measured: Day 5 to 9 after ovulation

  54. Low blood glucose index

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

  55. High blood glucose index

    Measured: Day 1 to 5 of the menstrual cycle

  56. High blood glucose index

    Measured: Day 6 until 2 days prior to ovulation

  57. High blood glucose index

    Measured: Ovulation plus/minus 1 day

  58. High blood glucose index

    Measured: Day 2 to 4 after ovulation

  59. High blood glucose index

    Measured: Day 5 to 9 after ovulation

  60. High blood glucose index

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

  61. Standard deviation of insulin delivery

    Measured: Day 1 to 5 of the menstrual cycle

  62. Standard deviation of insulin delivery

    Measured: Day 6 until 2 days prior to ovulation

  63. Standard deviation of insulin delivery

    Measured: Ovulation plus/minus 1 day

  64. Standard deviation of insulin delivery

    Measured: Day 2 to 4 after ovulation

  65. Standard deviation of insulin delivery

    Measured: Day 5 to 9 after ovulation

  66. Standard deviation of insulin delivery

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

  67. Coefficient of variance of insulin delivery

    Measured: Day 1 to 5 of the menstrual cycle

  68. Coefficient of variance of insulin delivery

    Measured: Day 6 until 2 days prior to ovulation

  69. Coefficient of variance of insulin delivery

    Measured: Ovulation plus/minus 1 day

  70. Coefficient of variance of insulin delivery

    Measured: Day 2 to 4 after ovulation

  71. Coefficient of variance of insulin delivery

    Measured: Day 5 to 9 after ovulation

  72. Coefficient of variance of insulin delivery

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

  73. Total insulin delivery

    Measured: Day 1 to 5 of the menstrual cycle

  74. Total insulin delivery

    Measured: Day 6 until 2 days prior to ovulation

  75. Total insulin delivery

    Measured: Ovulation plus/minus 1 day

  76. Total insulin delivery

    Measured: Day 2 to 4 after ovulation

  77. Total insulin delivery

    Measured: Day 5 to 9 after ovulation

  78. Total insulin delivery

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2022
  2. Study start2 May 2022
  3. Primary completion1 Apr 2026 (estimated)
  4. Study completion31 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
86 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05258292
Sponsor's protocol ID
2022-1165
Acronym
GLYMETY
Status last verified
Mar 2026
First submitted
17 Feb 2022
Last updated
5 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Type1diabetes, run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anne Bonhoure (514-987-5500 ext. 3238, anne.bonhoure@ircm.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean glucose levels during the early follicular phase (time frame: Day 1 to 5 of the menstrual cycle). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05258292.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.

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