Evaluating the effects of Semaglutide and Empagliflozin with Automated Insulin Delivery on diabetes control in adults with Type 1 Diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the effectiveness of Semaglutide and Empagliflozin, both individually and in combination, when added to Automated Insulin Delivery (AID) systems for improving time-in-range in adults with Type 1 Diabetes (T1D). The study employs a 2x2 factorial, randomized, placebo-controlled, double-blind, crossover design, allowing participants to receive all treatment combinations. The primary focus is to determine if the combination therapy enhances diabetes control compared to placebo and to evaluate the safety of these medications in this context.

Why it matters

Who can join: the full rules

The inclusion criteria at the time of enrollment are:

* Males and females aged 18 or older.
* Clinical diagnosis of T1D for at least one year.
* Use of AID system for at least three months.
* Body Mass Index (BMI) ≥ 23 kg/m2.

The exclusion criteria are:

* Use of GLP1-RA within one month of admission.
* Use of SGLT2i within two weeks of admission.
* Planned or ongoing pregnancy.
* Breastfeeding.
* Severe hypoglycemic episode within three months of admission (defined as an event where blood glucose levels were \< 4.0 mmol/L, resulting in seizure, loss of consciousness, or the need to present to the emergency department).
* Diabetic ketoacidosis episode within six months of admission.
* History of acute pancreatitis, chronic pancreatitis, or gallbladder disease.
* Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2.
* Severe impairment of renal function with an eGFR \< 30 mL/min/1.73 m2 within four months of admission. eGFR will be computed using the CKD-EPI method.
* Clinically significant diabetic retinopathy or gastroparesis, as per the investigator's judgement.
* Bariatric surgery within six months of admission.
* A serious medical or psychiatric illness that would likely interfere with participation in this study, as per the investigator's judgement.
* Inability or unwillingness to comply with safe diabetes management practices, as per the investigator's judgment.

Where it's running

• Research Institute of the McGill University Health Centre
  Montreal, Quebec, Canada Recruiting

Study contacts

• Principal investigator: Dr. Michael Tsoukas — Division of Endocrinology and Metabolism - McGill University Health Center
• Study coordinator: Keddy Moise, BScHS
• Email: keddy.moise@affiliate.mcgill.ca
• Phone: 438-531-6896

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Remote-patient monitoring in diabetes care shows real-world outcomes

  A real-world, pre-post observational study at Steno Diabetes Center Copenhagen tests whether adding remote-patient-monitoring within the EHR can maintain glycemic outcomes over two years for about 12,000 people with diabetes compared with prior ambulatory care.

  Recruiting Steno Diabetes Center Copenhagen · Herlev · NCT07617519

• Brain insulin resistance and brain health in people with diabetes

  This project will test whether brains that don't respond well to insulin in people aged 50–80 with type 1 or type 2 diabetes are linked to worse thinking and structural brain changes compared with people without diabetes.

  Recruiting at 3 sites Copenhagen University Hospital, Rigshospitalet · Glostrup Municipality and 2 other locations · NCT07374705

• Person-centred nutritional education to promote a healthy Nordic diet for adults with Type 1 diabetes

  This project tests whether person-centred nutrition education that supports a healthy Nordic diet can improve blood sugar time-in-range in adults with Type 1 diabetes compared with brief dietary information.

  Recruiting Umeå University · Enköping, Uppland · NCT07258758

• Improving care for diabetes-related emotional distress in adults with type 1 diabetes

  This project will test a care pathway that trains NHS diabetes teams to spot and talk about diabetes-related emotional distress and offer an online group program for adults with type 1 diabetes who use continuous glucose monitoring.

  Recruiting at 3 sites Guy's and St Thomas' NHS Foundation Trust · Bath and 2 other locations · NCT07193446

• Using the mylife CamAPS FX with the Dexcom G6 for people with type 1 diabetes in France

  This project will see if using the mylife CamAPS FX hybrid closed-loop system paired with the Dexcom G6 sensor improves blood sugar control over one year in people with type 1 diabetes in France.

  Recruiting at 22 sites mylife Diabetes Care AG · Amiens and 21 other locations · NCT07048795

• Evaluating contactless devices for measuring skin microcirculation in type 1 diabetes

  This study is testing two new contactless devices to see how well they can measure blood flow in the skin of people with type 1 diabetes.

  Recruiting HJN Sverige AB/Neko Health · Stockholm · NCT06989190

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.