What is tirzepatide studying for in this type 1 diabetes trial?

This trial is studying whether tirzepatide, given once weekly with an insulin pump, can help adults with type 1 diabetes manage blood sugar without counting carbohydrates at meals. Researchers want to see if tirzepatide can safely simplify diabetes management and reduce treatment burden. The study is sponsored by McGill University Health Centre.

Who may be eligible for this type 1 diabetes clinical trial?

Adults aged 18 years or older with type 1 diabetes for at least one year may be eligible. Participants must have a BMI of 27 or higher and actively count carbohydrates for insulin dosing. Both men and women can join, but women of childbearing potential must use effective birth control. Please review eligibility criteria for more details.

Is there any cost to participate in this type 1 diabetes clinical trial?

Study-related care, including tirzepatide injections, insulin pump, glucose monitor, and all trial visits, is provided at no cost. However, personal travel expenses and other costs may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 2

Phase 3

Age: 18Years +

All Genders

ID07284511

Testing Weekly Tirzepatide Injections to Simplify Blood Sugar Control in Adults With Type 1 Diabetes Using Automated Insulin Pumps

Led by McGill University Health Centre/Research Institute of the McGill University Health Centre · Updated on 2026-05-27

105

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to find out if the weekly medication tirzepatide can help adults with type 1 diabetes use their insulin pump more easily by reducing or stopping the need to count carbohydrates at meals. People with type 1 diabetes must take insulin for life, but counting carbs is challenging and stressful. Tirzepatide, approved for type 2 diabetes and weight management, may lower appetite, slow digestion, reduce insulin needs, and smooth blood sugar rises after meals in type 1 diabetes as well. The study includes 105 adults with type 1 diabetes, all using the Tandem Control-IQ insulin pump paired with the Dexcom G7 continuous glucose monitor. Participants are randomly assigned to two groups one receives weekly tirzepatide injections with gradually increasing doses for 12 weeks, then stops counting carbs for the last 6 weeks while continuing tirzepatide the other group continues usual therapy, counting carbs throughout. Both groups use the same insulin delivery system and receive training and monitoring. Participants attend clinic visits, complete remote follow-ups, and undergo lab tests, with some also having heart and body composition assessments. Researchers monitor glucose control, insulin use, weight, metabolic markers, meal patterns, and quality of life. The main outcome is whether glucose control without carb counting is as good as with standard care. Safety is closely watched due to possible side effects like nausea and rare risks such as gallbladder disease. The study lasts 32 weeks and aims to see if tirzepatide can simplify diabetes care safely.

CONDITIONS

Brief Title

A Clinical Trial Using Tirzepatide to Help Adults With Type 1 Diabetes Automatically Control Their Blood Sugar

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age 18 years or older
Clinical diagnosis of type 1 diabetes for at least 1 year
Body mass index (BMI) of 27 kg/m2 or higher
HbA1c greater than 6.5% and less than 12%
Using multiple daily insulin injections or insulin pump therapy
Willing to use Tandem Control-IQ insulin pump system with compatible rapid or ultra rapid-acting insulins
Actively counting carbohydrates for prandial insulin dosing
Women of childbearing potential must use effective birth control

You will not qualify if you...

Use of GLP1 receptor agonists within the last 4 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
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 less than 30 mL/min/1.73 m2
Clinically significant proliferative diabetic retinopathy or gastroparesis
Current or recent use (less than or equal to 1 month) of high-dose oral or intravenous glucocorticoids
History of bariatric surgery within the last 6 months
Medical or psychiatric illness likely to interfere with participation
Inability or unwillingness to comply with safe diabetes management practices
Any safety concern that precludes participation in the investigator's judgment

Research Team

Keddy Moise, MSc (candidate)

Rebecca Boyer-Hernandez, BSc

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