Weekly Subcutaneous Semaglutide as Adjunct to Closed-loop Therapy in Type 1 Diabetes Care (SEMA-AP)

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Insulin, Closed-loop system, GLP-1 receptor agonist, Semaglutide, Artificial Pancreas, Diabetes Mellitus, Type 1 Read More

Inclusion Criteria:

• 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 Criteria:

1. Current or < 2 week use of another GLP1-receptor agonist
2. Less than 2 weeks use of any anti-hyperglycemic agent other than insulin
3. Planned or ongoing pregnancy
4. Breastfeeding individuals
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 <15 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. History of bariatric surgery within 6 months of screening
12. 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)
13. Prior adverse reaction to GLP1-RAs
14. Body mass index ≤ 21 kg/m2
15. Regular use of hydroxyurea during the expected time of Dexcom G6 use, as this medication is known to cause inaccurate measurements (43)
16. Failure to comply to the study protocol and/or research group's recommendations (e.g. change in pump parameters, ketone measurement)
17. 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)
18. Any demonstrate of difficulty in using the iMAP system following training, as per investigator's judgment
19. 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.**