Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
ID07284511

Fully Closed-Loop Glucose Control in Adults With Type 1 Diabetes Using Tirzepatide: a Randomized, Multi-center, Open-label, Non-inferiority, Parallel Trial

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

105

Participants Needed

4

Research Sites

52 weeks

Total Duration

On this page

Sponsors

M

McGill University Health Centre/Research Institute of the McGill University Health Centre

Lead Sponsor

B

Breakthrough T1D

Collaborating Sponsor

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

Eligible

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
Not Eligible

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Run-in Period

Duration - Not specified

Participants receive training and start using the Tandem Control-IQ insulin pump system with Dexcom G7 continuous glucose monitor before randomization.

1 baseline visit (in-person)

Treatment

Duration - 32 weeks

Participants are randomly assigned to either receive once-weekly tirzepatide injections with dose escalation over 12 weeks plus carbohydrate counting for 26 weeks, or to use the Tandem Control-IQ system with standard carbohydrate counting for all 32 weeks. Participants in the tirzepatide arm stop carbohydrate counting and meal announcements during the final 6 weeks while continuing tirzepatide at their maintenance dose. All participants use the automated insulin delivery system throughout the 32-week study.

Scheduled clinic visits and remote follow-ups throughout the study, including insulin-pump adjustments and safety assessments

Follow-up

Duration - 16 weeks post-study

Participants undergo post-treatment assessments including safety monitoring, metabolic, cardiovascular, and patient-reported outcomes at Week 8 and Week 16 after study completion.

2 visits (post-study Week 8 and Week 16)

Trial Site Locations

Total: 4 locations

1

Institut de Recherches Cliniques de Montréal

Montreal, Quebec, Canada, H2W 1R7

Not Yet Recruiting

2

McGill University Health Centre

Montreal, Quebec, Canada, H4A 3J1

Not Yet Recruiting

3

Hygea Medical Clinic

Montreal, Quebec, Canada, H4A 3T2

Actively Recruiting

4

Insel Hospital, University Hospital Bern

Bern, Switzerland, 3010

Not Yet Recruiting

Loading map...

Research Team

K

Keddy Moise, MSc (candidate)

R

Rebecca Boyer-Hernandez, BSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

A Hybrid Effectiveness-implementation Trial of an Interventi...

Type 1 Diabetes Mellitus

Actively Recruiting

1 location

TEPLIzumab: Quality of Life Evaluation During Stage Transiti...

Type 1 Diabetes

Actively Recruiting

1 location

A National Screening Program for Islet Autoantibodies Among ...

Type 1 Diabetes

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Psychometric properties and factor structure of the Three-Factor Eating Questionnaire (TFEQ) in obese men and women. Results from the Swedish Obese Subjects (SOS) study.

J Karlsson, L O Persson, L Sjöström...

https://pubmed.ncbi.nlm.nih.gov/11126230

Subcutaneous weekly semaglutide with automated insulin delivery in type 1 diabetes: a double-blind, randomized, crossover trial.

Melissa-Rosina Pasqua, Michael A Tsoukas, Alessandra Kobayati...

https://pubmed.ncbi.nlm.nih.gov/39794615

Efficacy and Safety of Once-Weekly Semaglutide Versus Exenatide ER in Subjects With Type 2 Diabetes (SUSTAIN 3): A 56-Week, Open-Label, Randomized Clinical Trial.

Andrew J Ahmann, Matthew Capehorn, Guillaume Charpentier...

https://pubmed.ncbi.nlm.nih.gov/29246950

Efficacy and safety of once-weekly semaglutide 1.0mg vs once-daily liraglutide 1.2mg as add-on to 1-3 oral antidiabetic drugs in subjects with type 2 diabetes (SUSTAIN 10).

M S Capehorn, A-M Catarig, J K Furberg...

https://pubmed.ncbi.nlm.nih.gov/31539622