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New study tracks blood sugar swings across periods in type 1 diabetes

NCT ID NCT05258292

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at how blood sugar levels change during the menstrual cycle in women with type 1 diabetes. Researchers will track 86 women in Canada using continuous glucose monitors, insulin data, ovulation kits, and activity trackers. The goal is to understand why insulin needs often shift during the cycle, which could lead to better diabetes management.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If this study succeeds, it could help women with type 1 diabetes better manage their insulin needs throughout their menstrual cycle.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly improve health. Results may vary and not apply to all women.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 86 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2022

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Women aged 18 to 50 living with type 1 diabetes.

Ages

18 to 50 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Institut de recherches cliniques de Montréal

    RECRUITING

    Montreal, Quebec, H2W 1R7, Canada

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