Using a closed-loop system with semaglutide to simplify diabetes management

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 investigates the use of semaglutide, a GLP-1 receptor agonist, in conjunction with a closed-loop insulin delivery system for patients with type 1 diabetes. The study aims to determine if weekly semaglutide injections can maintain glucose control without the need for carbohydrate counting, compared to a placebo. Participants will undergo two blinded interventions, receiving either semaglutide or placebo, while following various meal strategies over a series of weeks. The goal is to assess the effectiveness of semaglutide in improving diabetes management and reducing the burden of carbohydrate counting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. At least 18 years of age
2. 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)
3. 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. Child-bearing 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:

1. Use of GLP1-RAs within the last 4 weeks.
2. Use of any anti-hyperglycemic agent other than insulin within the last 2 weeks.
3. Planned or ongoing pregnancy
4. Breastfeeding
5. 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
6. Severe diabetic ketoacidosis (DKA) within the last 6 months ("severe" referring to need to present to medical attention and requirement of intravenous insulin)
7. Prior history of acute pancreatitis, chronic pancreatitis, or gallbladder disease
8. Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2
9. Severe impairment of renal function with eGFR \<30 mL/min/1.73 m2 (using CKD-EPI formula), measured within the last 12 months
10. Clinically significant diabetic retinopathy or gastroparesis, as per the clinical judgment of the investigator
11. Bariatric surgery within the last 6 months.
12. 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).
13. Body mass index ≤ 21 kg/m2
14. 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)
15. Concern for safety of the participant, as per the clinical judgment of the primary investigator

Where it's running

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

Study contacts

• Study coordinator: Gabrielle Kemp, Registered Nurse
• Email: gabrielle.kemp@rimuhc.ca
• Phone: (438) 886-2171

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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.