Type 1 Diabetes Trial, Recruiting NCT05258292 Sponsor: Institut de Recherches Cliniques de Montreal Condition: Type 1 Diabetes
Back to Type 1 Diabetes

Type 1 Diabetes Trial, Recruiting

NCT05258292
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Women aged 18 to 50 who live in Canada
  • People who have been diagnosed with type 1 diabetes or a related condition called latent autoimmune diabetes in adults (LADA) for at least one year
  • People who have been using an insulin pump, multiple daily insulin injections, or an automated insulin delivery system for at least 3 months
  • People who are currently using a continuous glucose monitor (a device that tracks blood sugar levels throughout the day)
  • People who have had at least one menstrual period in the last 40 days
  • People who are willing to share their glucose monitor data (and insulin pump data if applicable) with the research team during the study period
  • People who have access to a smartphone or tablet that can be used to track menstrual cycles
  • People whose weight has been stable (less than 5% change) over the last 3 months

Who may not be able to join:

  • People using a hormonal contraception method that stops periods, such as the Depo-Provera injection, a progestin-releasing intrauterine device, or an extended-cycle birth control pill
  • People using certain older forms of regular insulin (such as Entuzity U500, Novolin ge Toronto, or Humulin R)
  • People with significant kidney problems or nerve-related conditions such as uncontrolled gastroparesis (a condition affecting stomach emptying), as assessed by the study doctor
  • People who have had a serious heart or blood vessel event (such as a heart attack or cardiac surgery) within the last 6 months
  • People for whom a change in insulin type, glucose monitor, insulin pump, or automated insulin device is planned before the end of the study
  • People who are planning to start, stop, or change their contraception method during the study
  • People who expect to need regular high doses of acetaminophen (paracetamol) during the study (above 1g every 6 hours)
  • People who are currently pregnant or actively trying to become pregnant
  • People who are currently breastfeeding
  • People with thyroid disease that is not well controlled, or whose thyroid treatment has not been stable for at least 6 weeks
  • People who have had a severe low blood sugar episode within two weeks of screening for the trial
  • People who have been hospitalised due to a severe high blood sugar episode in the last 3 months
  • People currently using steroid (glucocorticoid) medications, except for low stable doses, inhaled steroids, or stable treatment for adrenal insufficiency
  • People using certain medications that affect stomach emptying or certain diabetes tablets (such as Metformin or DPP-4 inhibitors), unless the dose has been stable for 3 months and no change is planned
  • People using a class of diabetes medication called SGLT-2 inhibitors, unless the dose has been stable for at least 3 months, no change is planned, and appropriate ketone monitoring is being carried out
  • People with other serious medical conditions that the study doctor believes would interfere with completing the study
  • People who are planning a significant change in exercise habits or diet during the study period (for example, starting or stopping a sport, or making a major dietary change)
  • People who expect to have repeated MRI scans or similar imaging during the study that would require removing the glucose monitor for more than 10 days
  • People who, in the study doctor's opinion, are unlikely or unwilling to complete the study
  • People taking thyroid medication (such as levothyroxine) whose dose has changed in the last 6 weeks

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal

Phone: 514-987-5500

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Institut de Recherches Cliniques de Montreal
Registry
ClinicalTrials.gov
Start date
2 May 2022
Est. completion
1 April 2026

Where this trial is recruiting

🇨🇦 Canada

Primary endpoints

Mean glucose levels during the early follicular phase; Mean glucose levels during the mid-late follicular phase; Mean glucose levels during the periovulation phase; Mean glucose levels during the early luteal phase; Mean glucose levels during the mid-luteal phase; Mean glucose levels during the late luteal phase

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov