Type 1 Diabetes study: Semaglutide with
Official title Alleviating Carbohydrate Counting for Patients with Type-1 Diabetes Using a Closed Loop System with Weekly Subcutaneous Semaglutide
ClinicalTrials.gov ID: NCT06387199
What this study is testing
What is Semaglutide with 4 meal strategies?
An investigational once‑weekly injectable medicine being studied for type 1 diabetes. is designed to increase levels of the hormone GLP‑1, which slows stomach emptying and reduces glucagon release.
Also referred to as Semaglutide.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will see whether adding semaglutide to an automated insulin system lets patients simply announce meals instead of counting carbs, while keeping blood sugar control stable.
- Who it's for
- Adults with type‑1 diabetes who use an automated insulin delivery system.
- What's involved
- Participants will receive either semaglutide or a placebo injection once a week and will use the insulin system for 50 weeks, reporting meals and having regular check‑ups and tests.
- Time commitment
- The trial lasts 50 weeks, with scheduled visits and monitoring throughout the study period.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- At least 18 years of age
- A clinical diagnosis of T1D for at least one year, as per their treating diabetes physician in agreement with the primary investigator's clinical...
- Minimum 3-month use of a commercial advanced automated insulin delivery system. 4.4.
You likely can't join if
- Use of GLP1-RAs within the last 4 weeks.
- Use of any anti-hyperglycemic agent other than insulin within the last 2 weeks.
- Planned or ongoing pregnancy
- Breastfeeding
- Severe hypoglycemic episode within the last 3 months, defined as an event where glucose was \< 4 mmol/L resulting in seizure, loss of consciousness...
- Severe diabetic ketoacidosis (DKA) within the last 6 months ("severe" referring to need to present to medical attention and requirement of...
See the full eligibility criteria
- At least 18 years of age
- A clinical diagnosis of T1D for at least one year, as per their treating diabetes physician in agreement with the primary investigator's clinical judgment (confirmatory C-peptide and antibodies will not be required)
- Minimum 3-month use of a commercial advanced automated insulin delivery system. 4.4. Agreement to use an effective method of birth control for individuals with child-bearing potential.
- Use of GLP1-RAs within the last 4 weeks.
- Use of any anti-hyperglycemic agent other than insulin within the last 2 weeks.
- Planned or ongoing pregnancy
- Breastfeeding
- Severe hypoglycemic episode within the last 3 months, defined as an event where glucose was \< 4 mmol/L resulting in seizure, loss of consciousness, or need to present to the emergency department
- Severe diabetic ketoacidosis (DKA) within the last 6 months ("severe" referring to need to present to medical attention and requirement of intravenous insulin)
- Prior 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 eGFR \<30 mL/min/1.73 m2 (using CKD-EPI formula), measured within the last 12 months
- Clinically significant diabetic retinopathy or gastroparesis, as per the clinical judgment of the investigator
- Bariatric surgery within the last 6 months.
- A serious medical or psychiatric illness that is likely to interfere with study participation as per the judgment of the investigator (e.g. cirrhosis, active cancer, decompensated schizophrenia).
- Body mass index ≤ 21 kg/m2
- Inability or unwillingness to comply to safe diabetes management in the view of the study group (e.g. inappropriate treatment of hypoglycemia or lack thereof)
- Concern for safety of the participant, as per the clinical judgment of the primary investigator
The study team makes the final eligibility decision.
Where it is enrolling
- Montreal, Quebec, Canada
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Montreal, Quebec, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.