Status:
COMPLETED
Weekly Subcutaneous Semaglutide as Adjunct to Closed-loop Therapy in Type 1 Diabetes Care
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions:
Type 1 Diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
A closed-loop insulin system, also referred to as the "artificial pancreas" (AP), is made up of an insulin pump, a continuous glucose monitor, and an application communicating between the two to adjus...
Eligibility Criteria
Inclusion
- 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)
- Glycated hemoglobin (HbA1c) up to 11% (inclusive), performed within the last 6 months prior to study inclusion
- Insulin pump use (of any modality) for minimum 3 months
- Agreement to the use of highly effective method of birth control in persons of child-bearing age (if sexually active) and active avoidance of pregnancy during the trial. Child-bearing potential refers to participants of the female sex post-menarche and have not reached menopause or have a disclosed medical condition causing sterility (e.g. hysterectomy). Post-menopausal state refers to the absence of menses for 12 months without any alternative cause.
Exclusion
- Current or \< 2 week use of another GLP1-receptor agonist
- Less than 2 weeks use of any anti-hyperglycemic agent other than insulin
- Planned or ongoing pregnancy
- Breastfeeding individuals
- 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 \<15 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
- History of bariatric surgery within 6 months of screening
- Any serious medical or psychiatric illness likely to interfere with study participation as per the judgment of the investigator (e.g. cirrhosis, active cancer, decompensated schizophrenia)
- Prior adverse reaction to GLP1-RAs
- Body mass index ≤ 21 kg/m2
- Regular use of hydroxyurea during the expected time of Dexcom G6 use, as this medication is known to cause inaccurate measurements (43)
- Failure to comply to the study protocol and/or research group's recommendations (e.g. change in pump parameters, ketone measurement)
- 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)
- Any demonstrate of difficulty in using the iMAP system following training, as per investigator's judgment
- Concern for safety of the participant, as per the clinical judgment of the primary investigator
- \*\*Note that for reasons of medicolegal protection for medical supervision, participants must be Canadian residents.\*\*
Key Trial Info
Start Date :
October 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2024
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT05205928
Start Date
October 2 2022
End Date
June 30 2024
Last Update
January 22 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Institute of the McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1