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Type 1 DiabetesPhase 2/3TZPNCT07284511

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

A Phase 2/3 study testing Tirzepatide, Carbohydrate Counting and No Meal Announcement in people with Type 1 Diabetes and Type 1 Diabetes Mellitus, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 4 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 1 Diabetes, Type 1 Diabetes Mellitus, T1D
What is being tested?
Tirzepatide, Carbohydrate Counting and No Meal Announcement
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
4 sitesin 2 countries
Study dates
19 May 2026to Jan 2029
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Keddy Moise, MSc (candidate) contact

438-531-6896

keddy.moise@mail.mcgill.ca

Rebecca Boyer-Hernandez, BSc contact

rebecca.boyer-hernandez@affiliate.mcgill.ca

4 sites in 2 countries

Canada3 sites, 3 recruiting

  • Institut de Recherches Cliniques de Montréal

    Montreal, Quebec, H2W 1R7

    Rémi Rabasa-Lhoret, MD-PhD, 514-987-5762, remi.rabasa-lhoret@umontreal.ca

    Rémi Rabasa-Lhoret, MD-PhD

    Not yet recruiting

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1

    Keddy Moise, MSc (candidate), 438-531-6896, keddy.moise@mail.mcgill.ca

    Rebecca Boyer-Hernandez, BSc., 514-318-7298, rebecca.boyer-hernandez@affiliate.mcgill.ca

    Not yet recruiting

  • Hygea Medical Clinic

    Montreal, Quebec, H4A 3T2

    Keddy Moise, MSc (candidate), 438-531-6896, keddy.moise@mail.mcgill.ca

    Rebecca Boyer-Hernandez, BSc, rebecca.boyer-hernandez@affiliate.mcgill.ca

    Recruiting

Other trials in Canada

Switzerland1 site, 1 recruiting

  • Insel Hospital, University Hospital Bern

    Bern, 3010

    Tabea Schoenfeldt-Reichmann, PhD, +41 31 664 34 17, evatabea.schoenfeldt-reichmann@extern.insel.ch

    Lia Bally, MD-PhD

    Not yet recruiting

Other trials in Switzerland

About this study

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

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.

Read more

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.

Read the detailed description

Current diabetes technology, including hybrid automated insulin delivery systems like the Tandem Control-IQ paired with the Dexcom G7 continuous glucose monitor, improves glucose control but still relies heavily on patients entering carbohydrate amounts before eating, a task that is difficult, error-prone, and often stressful.

Tirzepatide, which is approved for type 2 diabetes and weight management, works by slowing digestion, lowering appetite, reducing insulin requirements, and improving after-meal glucose spikes, and early evidence suggests it may offer similar benefits in type 1 diabetes. This study is designed to determine whether adding once-weekly tirzepatide injections to a commercially available automated insulin delivery system can make diabetes management easier for adults with type 1, particularly by reducing or eliminating the need to count carbohydrates at meals.

In this 32-week trial, 105 adults will be randomly assigned to receive tirzepatide or no tirzepatide while all participants use the Control-IQ system. Those receiving tirzepatide will gradually increase their dose over 12 weeks, continue counting carbohydrates until week 26, and then stop announcing meals entirely for the final 6 weeks, while the control group will count carbohydrates throughout.

Across the study, participants will attend scheduled clinic visits, complete remote follow-ups, undergo laboratory tests, and, depending on the site, may complete heart function tests, body-composition scans, fitness testing, or gastric emptying assessments. Researchers will compare glucose control, insulin needs, weight, metabolic markers, meal patterns, and patient-reported outcomes between groups, with the primary goal of determining whether glucose management without carbohydrate counting is not worse than (non-inferior to) standard carbohydrate counting.

The study also closely monitors safety, as tirzepatide can cause nausea, vomiting, diarrhea, decreased appetite, and rare complications such as gallbladder disease or pancreatitis. Overall, this research aims to learn whether combining tirzepatide with automated insulin delivery can safely simplify diabetes management, reduce treatment burden, and improve metabolic outcomes for adults living with type 1 diabetes.

Being tested
Tirzepatide, Tandem Control-IQ Automated Insulin Delivery System (with Dexcom G7 CGM), Carbohydrate Counting, No Meal Announcement
Keywords
Type 1 Diabetes, Overweight or obesity in type 1 diabetes, Automated insulin delivery, Insulin pump, Continuous glucose monitoring, Tirzepatide, Mounjaro, GIP/GLP-1 receptor agonist, Dual incretin therapy, Adjunctive tirzepatide therapy, Tandem Control-IQ, Hybrid closed-loop system, Closed-loop insulin delivery, Dexcom G7
Medical subject headings
Diabetes Mellitus, Type 1, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TirzepatideDrug

    Also called Mounjaro

    Tirzepatide, administered as a once-weekly subcutaneous injection, initiated at 2.5 mg and escalated in 2.5-mg increments every 4 weeks to a target of 10 mg or the maximally tolerated dose, used as an adjunct therapy in adults with type 1 diabetes using the Tandem Control-IQ automated insulin delivery system.

  • Tandem Control-IQ Automated Insulin Delivery System (with Dexcom G7 CGM)Device

    Also called Control-IQ, Dexcom G7

    This intervention uses the Tandem t:slim X2 insulin pump with the Control-IQ automated insulin delivery algorithm, integrated with the Dexcom G7 continuous glucose monitor. The system adjusts basal insulin and delivers automated correction boluses based on real-time glucose values. All participants receive standardized training and use this system for the full 32-week study. Rapid-acting insulin compatible with Control-IQ is required. This intervention is distinguished by its use under two different operational strategies: standard carbohydrate counting in the control arm and complete omission of meal announcements during the final 6 weeks in the tirzepatide arm.

  • Carbohydrate CountingBehavioural

    Also called Meal Announcement

    Participants enter the estimated carbohydrate amount for every meal and snack into the Tandem Control-IQ insulin pump to calculate and deliver prandial insulin boluses. This reflects standard use of hybrid closed-loop systems. The procedure is maintained for the entire 32-week study in the control arm and during Weeks 1-26 in the tirzepatide arm.

  • No Meal AnnouncementBehavioural

    Also called Omission of Carbohydrate Counting

    Participants do not enter carbohydrate amounts or announce meals to the Tandem Control-IQ system. The pump operates without user-initiated prandial boluses, relying solely on automated basal adjustments and automated correction boluses. This intervention is implemented only in the tirzepatide arm during Weeks 27-32.

Study groups in NCT07284511
Study groupRoleWhat they receive
Tirzepatide groupExperimentalParticipants randomized to this arm receive once-weekly subcutaneous tirzepatide in addition to use of the Tandem Control-IQ insulin pump and Dexcom G7 continuous glucose monitor. Tirzepatide is initiated at 2.5 mg weekly and increased by 2.5 mg every 4 weeks to a target dose of 10 mg weekly or the maximally tolerated dose. Dose escalation may be delayed or reduced if participants experience intolerable gastrointestinal symptoms. During Weeks 1-26, participants continue standard carbohydrate counting for all meals. Beginning in Week 27, participants stop entering carbohydrate amounts into the pump (no meal announcements) for six weeks while continuing tirzepatide at their maintenance dose. Throughout the intervention, participants undergo regular safety assessments, remote glucose data reviews, insulin-pump parameter adjustments as needed, and scheduled in-person visits to monitor metabolic, cardiovascular, and patient-reported outcomes.
Receives: Drug: Tirzepatide; Device: Tandem Control-IQ Automated Insulin Delivery System (with Dexcom G7 CGM); Behavioral: Carbohydrate Counting; Behavioral: No Meal Announcement
Control groupActive comparatorParticipants randomized to the control arm use the Tandem Control-IQ automated insulin delivery system with the Dexcom G7 continuous glucose monitor, following standard-of-care diabetes management. They continue carbohydrate counting for all meals throughout the 32-week study and deliver prandial insulin boluses based on estimated carbohydrate intake, as is typical for users of hybrid closed-loop systems. No tirzepatide injections are administered. Participants receive the same device training, follow-up schedule, safety monitoring, glucose data reviews, and pump parameter adjustments as the tirzepatide arm. This arm serves as an active comparator, representing current standard therapy for type 1 diabetes with automated insulin delivery and meal announcements.
Receives: Device: Tandem Control-IQ Automated Insulin Delivery System (with Dexcom G7 CGM); Behavioral: Carbohydrate Counting

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Daytime Time-in-Range

    The primary outcome is the percentage of daytime hours (06:00-24:00) during which participants' glucose levels, measured by the Dexcom G7 continuous glucose monitor, fall within the target range of 3.9-10.0 mmol/L.

    Measured: During the final 6 weeks of the study

Secondary outcomes (31)

  1. Weight

    Change in body weight to assess the effects of tirzepatide on body composition. Weight is measured in kilograms.

    Measured: At enrollment, Week 8, Week 16, Week 24, and Week 32, At Week 8 and Week 16 post-study

  2. Height

    Change in height to assess the effects of tirzepatide on body composition. Height is measured in meters.

    Measured: At enrollment, Week 8, Week 16, Week 24, and Week 32, At Week 8 and Week 16 post-study.

  3. Body Mass Index

    Change in BMI to assess the effects of tirzepatide on body composition. BMI is measured in kilograms per square meter.

    Measured: At enrollment, Week 8, Week 16, Week 24, and Week 32, At Week 8 and Week 16 post-study

  4. Waist circumference

    Change in waist circumference to assess the effects of tirzepatide on body composition. Waist circumference is measured in centimetres.

    Measured: At enrollment, Week 8, Week 16, Week 24, and Week 32, At Week 8 and Week 16 post-study

  5. Waist-to-Hip Ratio

    Change in waist-to-hip ratio to assess the effects of tirzepatide on body composition. Waist-to-Hip Ratio is measured by dividing the waist circumference by the hip circumference. It is unitless.

    Measured: At enrollment, Week 8, Week 16, Week 24, and Week 32, At Week 8 and Week 16 post-study.

  6. Systolic Blood Pressure

    Change in systolic blood pressure to evaluate the cardiovascular effects of tirzepatide. Systolic blood pressure is measured in millimetres of mercury.

    Measured: At enrollment, Week 8, Week 16, Week 24, and Week 32, At Week 8 and Week 16 post-study.

  7. Diastolic Blood Pressure

    Change in diastolic blood pressure to evaluate the cardiovascular effects of tirzepatide. Diastolic blood pressure is measured in millimetres of mercury.

    Measured: At enrollment, Week 8, Week 16, Week 24, and Week 32, At Week 8 and Week 16 post-study.

  8. Resting Heart Rate

    Change in resting heart rate to assess the cardiovascular effects of tirzepatide. Resting heart rate is measured in beats per minute.

    Measured: At enrollment, Week 8, Week 16, Week 24, and Week 32, At Week 8 and Week 16 post-study.

  9. Insulin-related measures

    Daily insulin requirements, including basal insulin, bolus insulin, and total insulin units per day, recorded through the insulin pump.

    Total insulin use normalized to body weight (units/kg/day) to assess treatment-related changes in insulin sensitivity.

    Carbohydrate amounts entered for bolus dosing (control arm and Weeks 1-26 of tirzepatide arm).

    Measured: Continuously from randomization through Week 32, with primary analysis focused on Weeks 27-32, At Week 8 and Week 16 post-study.

  10. Glucose outcomes

    Percentage of CGM readings within 3.9-10.0 mmol/L, 3.9-7.8 mmol/L, <3.9 mmol/L, <3.0 mmol/L, >10.0 mmol/L, and >13.9 mmol/L, as well as mean glucose, glucose standard deviation, and glucose coefficient of variation.

    Measured: Continuously collected from randomization through Week 32, with key comparisons during Weeks 23-26 and Weeks 27-32, At Week 8 and Week 16 post-study.

  11. Glycated Hemoglobin (HbA1c)

    Change in glycated hemoglobin (HbA1c) to assess overall glycemic control over the study period.

    Measured: At enrollment, mid-study at Week 16, and at the end-of-study visit at Week 32, At Week 8 and Week 16 post-study.

  12. Estimated Glomerular Filtration Rate

    Changes in estimated glomerular filtration rate. eGFR is measured in millilitres/minute/body surface.

    Measured: At enrollment, Week 16, and Week 32, At Week 8 and Week 16 post-study.

  13. Serum Creatinine

    Changes in serum creatinine. Serum creatinine is measured in umol/L.

    Measured: At enrollment, Week 16, and Week 32, At Week 8 and Week 16 post-study.

  14. Albumin-to-Creatinine Ratio

    Changes in urinary albumin-to-creatinine ratio. Urinary albumin-to-creatinine ratio is measured in mg/mmol.

    Measured: At enrollment, Week 16, and Week 32, At Week 8 and Week 16 post-study.

  15. Lipid Panel (Total Cholesterol, LDL-C, HDL-C, Triglycerides)

    Changes in fasting lipid profile to assess cardiometabolic effects of tirzepatide. All components of the lipid panel are measured in millimole/liter.

    Measured: At enrollment, Week 16, and Week 32, At Week 8 and Week 16 post-study.

  16. Liver Function Markers (Alanine transaminase, Alkaline phosphatase)

    Changes in liver enzymes to monitor hepatic safety. Hepatic enzymes are measured in Units per Litre.

    Measured: At enrollment, Week 16, and Week 32, At Week 8 and Week 16 post-study.

  17. Liver Function Markers (Bilirubin)

    Changes in bilirubin to monitor hepatic safety. Bilirubin (Total, Direct, Indirect) are measured in micromoles per litre.

    Measured: At enrollment, Week 16, and Week 32, At Week 8 and Week 16 post-study.

  18. Cardiac Biomarkers (NT-proBNP)

    Serum biomarker used to assess cardiac strain, providing insights into the broader metabolic effects of tirzepatide. NT-proBNP is measured in picograms per millilitre.

    Measured: At enrollment, Week 16, and Week 32, At Week 8 and Week 16 post-study.

  19. Inflammatory Biomarkers (hs-CRP)

    Serum biomarkers used to assess inflammation providing insights into the broader metabolic effects of tirzepatide. hs-CRP is measured in milligrams per litre.

    Measured: At enrollment, Week 16, and Week 32, At Week 8 and Week 16 post-study.

  20. Inflammatory Biomarkers (IL-6)

    Serum biomarkers used to assess inflammation, providing insights into the broader metabolic effects of tirzepatide. IL-6 is measured in picograms per millilitre.

    Measured: At enrollment, Week 16, and Week 32, At Week 8 and Week 16 post-study.

  21. C-Peptide

    Change in fasting C-peptide to assess residual β-cell function.

    Measured: At enrollment and at Week 32, At Week 8 and Week 16 post-study.

  22. Carotid-Femoral Pulse Wave Velocity and Pulse Wave Analysis

    Measures of arterial stiffness and central blood pressure, used to evaluate vascular effects of treatment.

    Measured: At enrollment and at Week 32 (site-dependent).

  23. DXA Body Composition

    Whole-body DXA assessment of fat mass, lean mass, visceral fat, and bone density.

    Measured: At enrollment and at Week 32 (site-dependent).

  24. Echocardiogram (Diastolic Function Parameters)

    Assessment of cardiac structure and diastolic function, including E/A ratio, e', E/e', and left atrial volume.

    Measured: At enrollment and at Week 32 (site-dependent).

  25. VO₂-max Test

    Measurement of maximal oxygen consumption to evaluate cardiopulmonary fitness.

    Measured: At enrollment and at Week 32 (site-dependent).

  26. Quality-of-Life Measures (Diabetes Distress Scale)

    Changes in the standardized Diabetes Distress Scale using the validated questionnaire. A participant's score is measured as the sum of responses to the appropriate items divided by the number of items in that scale.

    A mean item score 2.0 - 2.9 is considered moderate distress, and a mean item score > 3.0 is considered high distress.

    Measured: At enrollment and at Week 32.

  27. Quality-of-Life Measures (Hypoglycemia Fear Survey II)

    Changes in the standardized Hypoglycemia Fear Survey II using the validated questionnaire.

    HFS-II Total Score range: 0-132.

    Higher scores on the total HFS-II indicate a greater fear of hypoglycemia. The questionnaire does not have pre-defined cut-off scores for diagnostic categories; instead, the scores are used to measure the level of fear.

    Measured: At enrollment and at Week 32.

  28. Quality-of-Life Measures (Three Factor Eating r18 Questionnaire)

    Changes in the standardized Three Factor Eating Questionnaire scores.

    The three-factor eating questionnaire provides a score from 0 to 100 for cognitive restraint, uncontrolled eating, and emotional eating. Higher scores indicate greater cognitive restraint, uncontrolled eating, and emotional eating.

    Measured: At enrollment and at Week 32.

  29. Gastric Emptying via [13C] Acetate Breath Test

    Rate of gastric emptying assessed by breath ¹³CO₂ appearance following standardized test meal.

    Measured: At enrollment (or training visit) and at Week 32 (site-dependent).

  30. Blood Glucagon Response to Standardized Meal

    Change in glucagon concentrations following ingestion of a standardized liquid meal.

    Measured: At enrollment and at Week 32 (site-dependent).

  31. Meal Tracking Using Keenoa or MyFood24

    Assessment of caloric intake and macronutrient composition via 3-day dietary records.

    Measured: Prior to randomization, during Week 16, and during Week 32.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2025
  2. Study start19 May 2026
  3. Primary completionJan 2028 (estimated)
  4. Study completionJan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a randomized, open-label, parallel-group clinical trial conducted at multiple centers. After a standardized run-in with the Tandem Control-IQ insulin pump and Dexcom G7 glucose sensor, adults with type 1 diabetes are randomized in balanced blocks to either adjunct tirzepatide or control. Randomization is stratified by site and baseline insulin therapy. Participants in both groups use the same automated insulin delivery system for 32 weeks. The tirzepatide group undergoes dose escalation, maintenance, and finally a no-meal-announcement phase, while the control group continues carbohydrate counting throughout. The primary analysis compares daytime (06:00-24:00) time-in-range (3.9-10.0 mmol/L) during the last four weeks using a non-inferiority framework. This design allows rigorous evaluation of whether tirzepatide enables safe omission of meal announcements while maintaining glucose control.
Masking
None (open label)
Enrolment
105 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07284511
Sponsor's protocol ID
2026-12143
Acronym
TZP
Status last verified
May 2026
First submitted
19 Nov 2025
Last updated
27 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
Yes: De-identified individual participant data may be shared with qualified researchers after completion of the trial and publication of the primary results. Shared data may include de-identified demographic variables, glucose and insulin delivery data, laboratory results, questionnaire scores, and device-based assessments collected during the study. All data will be reviewed to minimize re-identification risk in accordance with Canadian and Swiss privacy regulations. Researchers must submit a scientifically valid proposal and sign a data use agreement. Requests will be reviewed by the study team, and approved data will be provided through a secure transfer process.

Publications

  • Marso SP, Bain SC, Consoli A, Eliaschewitz FG, Jodar E, Leiter LA, Lingvay I, Rosenstock J, Seufert J, Warren ML, Woo V, Hansen O, Holst AG, Pettersson J, Vilsboll T; SUSTAIN-6 Investigators. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. 2016 Nov 10;375(19):1834-1844. doi: 10.1056/NEJMoa1607141. Epub 2016 Sep 15.

    PubMed 27633186

  • Karlsson J, Persson LO, Sjostrom L, Sullivan M. 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. Int J Obes Relat Metab Disord. 2000 Dec;24(12):1715-25. doi: 10.1038/sj.ijo.0801442.

    PubMed 11126230

  • Saisho Y. Use of Diabetes Treatment Satisfaction Questionnaire in Diabetes Care: Importance of Patient-Reported Outcomes. Int J Environ Res Public Health. 2018 May 9;15(5):947. doi: 10.3390/ijerph15050947.

    PubMed 29747423

  • Gonder-Frederick LA, Schmidt KM, Vajda KA, Greear ML, Singh H, Shepard JA, Cox DJ. Psychometric properties of the hypoglycemia fear survey-ii for adults with type 1 diabetes. Diabetes Care. 2011 Apr;34(4):801-6. doi: 10.2337/dc10-1343. Epub 2011 Feb 23.

    PubMed 21346182

  • Fisher L, Hessler D, Polonsky W, Strycker L, Masharani U, Peters A. Diabetes distress in adults with type 1 diabetes: Prevalence, incidence and change over time. J Diabetes Complications. 2016 Aug;30(6):1123-8. doi: 10.1016/j.jdiacomp.2016.03.032. Epub 2016 Apr 4.

    PubMed 27118163

  • Frias JP, Davies MJ, Rosenstock J, Perez Manghi FC, Fernandez Lando L, Bergman BK, Liu B, Cui X, Brown K; SURPASS-2 Investigators. Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes. N Engl J Med. 2021 Aug 5;385(6):503-515. doi: 10.1056/NEJMoa2107519. Epub 2021 Jun 25.

    PubMed 34170647

  • Martin C, Ravussin E, Sanchez-Delgado G, Nishiyama H, Li J, Urva S, et al. The effect of tirzepatide during weight loss on food intake, appetite, food preference and food craving in people with obesity. Can J Diabetes. 2023 Jul;47(7 Suppl):S199. doi:10.1016/j.jcjd.2023.10.370

  • Snell-Bergeon JK, Kaur G, Renner D, Akturk HK, Beatson C, Garg SK. Effectiveness of Semaglutide and Tirzepatide in Overweight and Obese Adults with Type 1 Diabetes. Diabetes Technol Ther. 2025 Jan;27(1):1-9. doi: 10.1089/dia.2024.0328. Epub 2025 Jan 2.

    PubMed 39745353

  • Pasqua MR, Tsoukas MA, Kobayati A, Aboznadah W, Jafar A, Haidar A. Subcutaneous weekly semaglutide with automated insulin delivery in type 1 diabetes: a double-blind, randomized, crossover trial. Nat Med. 2025 Apr;31(4):1239-1245. doi: 10.1038/s41591-024-03463-z. Epub 2025 Jan 10.

    PubMed 39794615

  • Ahmann AJ, Capehorn M, Charpentier G, Dotta F, Henkel E, Lingvay I, Holst AG, Annett MP, Aroda VR. 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. Diabetes Care. 2018 Feb;41(2):258-266. doi: 10.2337/dc17-0417. Epub 2017 Dec 15.

    PubMed 29246950

  • Capehorn MS, Catarig AM, Furberg JK, Janez A, Price HC, Tadayon S, Verges B, Marre M. 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). Diabetes Metab. 2020 Apr;46(2):100-109. doi: 10.1016/j.diabet.2019.101117. Epub 2019 Sep 17.

    PubMed 31539622

  • Gerstein HC, Colhoun HM, Dagenais GR, Diaz R, Lakshmanan M, Pais P, Probstfield J, Riesmeyer JS, Riddle MC, Ryden L, Xavier D, Atisso CM, Dyal L, Hall S, Rao-Melacini P, Wong G, Avezum A, Basile J, Chung N, Conget I, Cushman WC, Franek E, Hancu N, Hanefeld M, Holt S, Jansky P, Keltai M, Lanas F, Leiter LA, Lopez-Jaramillo P, Cardona Munoz EG, Pirags V, Pogosova N, Raubenheimer PJ, Shaw JE, Sheu WH, Temelkova-Kurktschiev T; REWIND Investigators. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. Lancet. 2019 Jul 13;394(10193):121-130. doi: 10.1016/S0140-6736(19)31149-3. Epub 2019 Jun 9.

    PubMed 31189511

  • Marso SP, Daniels GH, Brown-Frandsen K, Kristensen P, Mann JF, Nauck MA, Nissen SE, Pocock S, Poulter NR, Ravn LS, Steinberg WM, Stockner M, Zinman B, Bergenstal RM, Buse JB; LEADER Steering Committee; LEADER Trial Investigators. Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2016 Jul 28;375(4):311-22. doi: 10.1056/NEJMoa1603827. Epub 2016 Jun 13.

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  • Tsoukas MA, Cohen E, Legault L, von Oettingen JE, Yale JF, Vallis M, Odabassian M, El Fathi A, Rutkowski J, Jafar A, Ghanbari M, Gouchie-Provencher N, Rene J, Palisaitis E, Haidar A. Alleviating carbohydrate counting with a FiASP-plus-pramlintide closed-loop delivery system (artificial pancreas): Feasibility and pilot studies. Diabetes Obes Metab. 2021 Sep;23(9):2090-2098. doi: 10.1111/dom.14447. Epub 2021 Jun 21.

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  • Karakus KE, Klein MP, Akturk HK, Shah VN. Changes in Basal and Bolus Insulin Requirements with Tirzepatide as an Adjunctive Therapy in Adults with Type 1 Diabetes Using Tandem Control-IQ. Diabetes Ther. 2024 Jul;15(7):1647-1655. doi: 10.1007/s13300-024-01592-9. Epub 2024 May 14.

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Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Tirzepatide, Carbohydrate Counting and No Meal Announcement in people with Type 1 Diabetes and Type 1 Diabetes Mellitus, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Canada, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Keddy Moise, MSc (candidate) (438-531-6896, keddy.moise@mail.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Daytime Time-in-Range (time frame: During the final 6 weeks of the study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07284511, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.

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