Tirzepatide added to an automated insulin delivery system to help adults with type 1 diabetes manage blood sugar

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a 32-week Phase 2/3 interventional trial enrolling 105 adults with type 1 diabetes at sites in Canada and Switzerland. All participants will use a Tandem Control-IQ automated insulin delivery system with a Dexcom G7 continuous glucose monitor. The study compares tirzepatide versus no tirzepatide while both groups use carbohydrate counting for part of the trial, with the tirzepatide group gradually increasing dose and eventually stopping meal announcements in the final weeks to see if meal-coverage can be simplified without compromising glucose control. Primary aims are to see if tirzepatide can reduce insulin needs and improve post-meal glucose responses, while monitoring safety and changes in body weight and composition. Participants will have regular clinic visits, remote follow-ups, lab tests, and site-specific assessments such as heart function tests as applicable.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years.
* Clinical diagnosis of type 1 diabetes for ≥ 1 year, per investigator judgment (confirmatory C-peptide and autoantibodies not required).
* A BMI ≥ 27 kg/m2.
* HbA1c \> 6.5%, and \< 12%.
* Current therapy: multiple daily injections or insulin pump.
* Willingness to use Tandem Control IQ insulin pump system with the use of rapid or ultra rapid-acting insulins compatible with Tandem Control-IQ pump (e.g. Fiasp is not compatible)
* Active carbohydrate counting for prandial insulin dosing.
* Individuals of childbearing potential must be using or agree to use an effective birth-control method. Childbearing potential refers to participants of the female sex post-menarche who have not reached menopause and who do not have a medical condition causing sterility (e.g., hysterectomy). Post-menopausal state refers to the absence of menses for 12 months without any alternative cause.

Exclusion Criteria:

* Use of GLP1-RAs within the last four weeks.
* Use of antihyperglycemic agents other than insulin or metformin within the last 2 weeks.
* Planned or ongoing pregnancy.
* Breastfeeding.
* Severe hypoglycemia requiring hospitalization in the past 2 months. Severe hypoglycemia is defined as requiring the assistance of another person, due to altered consciousness, to administer carbohydrates, glucagon, or other resuscitative actions.
* Diabetic ketoacidosis within the last 2 months.
* History of acute or chronic pancreatitis.
* Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2.
* Severe renal impairment with eGFR \<30 mL/min/1.73 m2 (CKD-EPI), measured within the last four months.
* Clinically significant proliferative diabetic retinopathy or gastroparesis, as per the judgment of the investigator.
* Current or ≤ 1 month use of supraphysiological doses of oral or intravenous glucocorticoids.
* History of bariatric surgery within the last 6 months.
* Medical or psychiatric illness likely to interfere with participation (e.g. cirrhosis, active cancer, decompensated schizophrenia), per investigator judgment.
* Inability or unwillingness to comply with safe diabetes management practices, in the view of the investigator.
* Any safety concern that, in the investigator's judgment, precludes participation.

Where it's running

• Hygea Medical Clinic
  Montreal, Quebec, Canada Recruiting
• Institut de Recherches Cliniques de Montréal
  Montreal, Quebec, Canada Not yet recruiting
• McGill University Health Centre
  Montreal, Quebec, Canada Not yet recruiting
• Insel Hospital, University Hospital Bern
  Bern, Switzerland Not yet recruiting

Study contacts

• Principal investigator: Melissa-Rosina Pasqua, MD, PhD — McGill University Health Centre/Research Institute of the McGill University Health Centre
• Study coordinator: Keddy Moise, MSc (candidate)
• Email: keddy.moise@mail.mcgill.ca
• Phone: 438-531-6896

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.