Could a weekly injection free people with type 1 diabetes from carb counting?
NCT ID NCT07284511
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether tirzepatide, a weekly injection already used for type 2 diabetes, can help adults with type 1 diabetes use an automated insulin pump without needing to count carbohydrates at meals. About 105 participants will be randomly assigned to receive tirzepatide or continue standard care. The goal is to see if tirzepatide can safely maintain good blood sugar control while reducing the daily burden of diabetes management.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 105 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hygea Medical Clinic
RECRUITINGMontreal, Quebec, H4A 3T2, Canada
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Insel Hospital, University Hospital Bern
NOT_YET_RECRUITINGBern, 3010, Switzerland
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Institut de Recherches Cliniques de Montréal
NOT_YET_RECRUITINGMontreal, Quebec, H2W 1R7, Canada
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McGill University Health Centre
NOT_YET_RECRUITINGMontreal, Quebec, H4A 3J1, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Gene therapy aims to free type 1 diabetics from insulin shots
- Can skin sensors replace finger pricks for diabetes care in kenya?
- Muscle-Injected gene therapy aims to help type 1 diabetes control blood sugar
- Can a glucose sensor and family coaching tame type 1 diabetes in toddlers?
- Tiny horses, big lessons: can ponies help kids tame diabetes?
- Can a math model tune insulin pumps better than standard care?