💬In plain words
What the trial is, and whether it could suit you
This research study is testing whether a weekly medication called tirzepatide can help adults with type 1 diabetes use their insulin pump more easily, specifically by reducing or eliminating the need to count carbohydrates at meals.
People with type 1 diabetes must take insulin for life, and even with advanced insulin pumps and continuous glucose monitors, many still struggle to keep blood sugar within the target range. One of the biggest challenges is carbohydrate counting, which requires estimating the amount of carbohydrates in every meal to give the correct insulin dose.
Tirzepatide is a medication currently approved for type 2 diabetes and weight management. Early research suggests it may also help people with type 1 diabetes by lowering appetite, slowing digestion, reducing insulin needs, and smoothing after-meal blood sugar rises.
This study will include 105 adults with type 1
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
💊
What it tests
- Tirzepatide
- Tandem Control-IQ Automated Insulin Delivery System (with Dexcom G7 CGM)
- Carbohydrate Counting
- No Meal Announcement
Institut de Recherches Cliniques de Montréal
Montreal, Canada
McGill University Health Centre
Montreal, Canada
Hygea Medical Clinic
Montreal, Canada
Insel Hospital, University Hospital Bern
Bern, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.