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🏛️ Verified NIH Protocol • Sourced via U.S. National Library of Medicine (Last Synced: 2026-05-27)

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

🟢 Recruiting Phase 2 💊 Investigational Drug / Biologic Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

🩺 Protocol Summary

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 diabetes at centers in Canada and Switzerland. Everyone will use the Tandem Control-IQ insulin pump with a Dexcom G7 continuous glucose monitor. Participants are randomly assigned to one of two groups: Tirzepatide group: Participants receive weekly tirzepatide injections. After the dose is gradually increased over 12 weeks, they will eventually try using their insulin pump without entering carbohydrate amounts at meals. Control group: Participants continue their usual therapy and keep counting carbohydrates for their mealtime insulin doses. The main goal of the study is to learn whether people taking tirzepatide can safely maintain good blood sugar control without counting carbs, compared with standard care. All participants will attend several clinic visits and share their glucose, insulin, and health data throughout the 32-week trial. Some centers will also conduct heart/fitness, or body-composition tests. As with any medication, tirzepatide may cause side effects such as nausea, vomiting, diarrhea, or decreased appetite. Rare but serious risks like gallbladder disease or pancreatitis are also monitored. Pregnancy must be avoided during the trial. Overall, this study aims to understand whether adding tirzepatide to automated insulin delivery can simplify diabetes management, reduce burden, and maintain safe and effective glucose control for adults living with type 1 diabetes.

Primary Research Facility: Institut de Recherches Cliniques de Montréal (Montreal, Quebec)

📋 Basic Study Criteria & Logistics Checklist

0 of 3 Checked

Review these 3 basic logistical and protocol criteria extracted from the public NIH record. (This is a preliminary logistical checklist, not an official clinical eligibility determination).

📍 Primary Site Map

Site: Institut de Recherches Cliniques de Montréal — Montreal, Quebec

📍 All Participating Trial Locations (4 Sites)

Multi-Center Trial

This protocol is enrolling participants across multiple clinical centers:

1. Institut de Recherches Cliniques de MontréalMontreal, Quebec • Contact: (514) 987-5762
2. McGill University Health CentreMontreal, Quebec • Contact: (438) 531-6896
3. Hygea Medical ClinicMontreal, Quebec • Contact: (438) 531-6896
4. Insel Hospital, University Hospital BernUnited States • Contact: +41 31 664 34 17

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💰 Clinical Trial Costs & Insurance Coverage

Coverage for clinical trial participation varies depending on your health insurance policy, state legislation, and whether specific procedures are investigational research or routine medical care. Under federal law (Affordable Care Act § 2709), health insurers generally cannot drop coverage or refuse to pay for routine patient care costs incurred in approved clinical trials.

💡 Always ask the study coordinator for the trial's official Informed Consent Form, which outlines all sponsor-funded research items versus procedures billed to your insurance.

🏛️ Official Government Provenance

NIH ClinicalTrials.gov Protocol Record

NCT Identifier: NCT07284511 • Last Synced: 2026-05-27
View on ClinicalTrials.gov ↗
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