NCT06387199RecruitingPhase 2/3
Alleviating Carbohydrate Counting for Patients with Type-1 Diabetes Using a Closed Loop System with Weekly Subcutaneous Semaglutide
Alleviating Carbohydrate Counting Using Weekly Subcutaneous Semaglutide Injections in People with Type 1 Diabetes on Closed-Loop Insulin Therapy: a 2x4 Factorial Randomized Placebo-Controlled Trial
Source: ClinicalTrials.gov · Last updated 18 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
A closed-loop insulin system, often labelled the "artificial pancreas" (AP), consists of an insulin pump, a continuous glucose monitor, and an interface coordinating between them to regulate insulin dosage based on glucose levels. Primarily designed for managing type 1 diabetes, this system has demonstrated significant benefits in previous studies. Yet, despite these advantages, certain challenges persist. Semaglutide, utilized in treating type 2 diabetes and obesity, is a once-weekly injectable medication that elevates levels of a gastrointestinal hormone known as Glucagon-Like Peptide-1 (GLP-1). This hormone alters gastric emptying, inhibits glucagon release, and reduces appetite. While not officially sanctioned for type 1 diabetes treatment in North America, studies have explored its efficacy as an adjunctive therapy alongside insulin, yielding favorable outcomes in blood glucose regulation. Comparable drugs like liraglutide and exenatide have been employed in type 1 diabetes treatment as well, albeit with less pronounced glucose-regulating effects compared to semaglutide, even in type 2 diabetes. The goal of this 50-week randomized placebo-controlled crossover 2x4 factorial designed trial is to assess whether commercial automated insulin delivery (AID) systems using rapid-acting insulin with adjunct weekly injections of semaglutide (at the maximally tolerated dose) can replace carbohydrate counting with simple meal announcements (SMA) without degrading glucose control.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 26 (estimated)
- First submitted
- 18 Apr 2024
- Start date
- 1 Dec 2024
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Diseases
- Type 1 diabetes
- NCT number
- NCT06387199
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 26
- From 1 Dec 2024 to the primary completion date, 31 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior history of acute pancreatitis, chronic pancreatitis, or gallbladder disease
- Bariatric surgery within the last 6 months.
Other illness
- Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2
- 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).
- 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)
Lab values
- 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 impairment of renal function with eGFR \<30 mL/min/1.73 m2 (using CKD-EPI formula), measured within the last 12 months
Other
- 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 diabetic ketoacidosis (DKA) within the last 6 months ("severe" referring to need to present to medical attention and requirement of intravenous insulin)
- Clinically significant diabetic retinopathy or gastroparesis, as per the clinical judgment of the investigator
- Body mass index ≤ 21 kg/m2
- Concern for safety of the participant, as per the clinical judgment of the primary investigator
Who the study is looking for
- 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. 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.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Research Institute of the McGill University Health Centre Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.