ADJUnct Semaglutide Treatment in Type 1 Diabetes (ADJUST-T1D)

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 diabetes, Obesity, HbA1c, Time-in-range, Weight loss, Cardiovascular risk Read More

Inclusion Criteria:

For an eligible subject, all inclusion criteria must be answered "yes"

1. Age >18 years at screening
2. Patients with clinical diagnosis of T1D diagnosed for at least 12 months
3. Patient is on FDA- approved hybrid closed-loop system for ≥ 3 months
4. Willing to use once weekly semaglutide
5. Willing to share devices (HCL system) data uploads
6. Point-of-care HbA1c >7.0% and <10.0%
7. Body mass index ≥30 kg/m2
8. Has current glucagon product to treat severe hypoglycemia
9. Has current ketone meters to check ketones
10. Ability to provide informed consent before any trial-related activities

Exclusion Criteria:

1. Age ≤18 years and ≥60 years
2. HbA1c ≤7.0 % or ≥ 10.0% at screening
3. Less than 12 months of insulin treatment
4. Use of unapproved insulin for HCL system. E.g. use of Fiasp in the Tandem Control-IQ system
5. Not willing to share the devices (HCL system) data uploads
6. Unavailability of compatible smart phone for device data transfer
7. Current use of multiple daily injection or inhaled insulin (Afrezza)
8. Patients with T1D using any glucose lowering medications other than insulin at the time of screening
9. Pregnancy, breast feeding, and positive pregnancy test during screening
10. Women of childbearing age wanting to become pregnant or not using adequate contraceptive measures
11. Current use (≥ 2 weeks of continuous use) of any steroidal medication, or anticipated long-term steroidal treatment (>4 weeks continuously), during the study period
12. Use of GLP-1RA or weight loss medications in the past 3 month
13. Clinical diagnosis/history of gastroparesis or gastric motility disorders
14. Fasting serum triglycerides >500 mg/dL
15. Planning for bariatric surgery during the study period
16. eGFR below 45 ml/min/1.73 m^2 using MDRD formula
17. History of severe hypoglycemia in the previous 3 months
18. History of diabetic ketoacidosis requiring hospitalization in the past 3 months
19. History of allergy to any form of insulin, GLP-1RA or its excipients
20. History of any form of pancreatitis
21. History of stroke, myocardial infarction in the past 3 months
22. History of congestive heart failure class III or IV
23. History of acute or chronic liver disease
24. History of malignancy requiring chemotherapy, surgery or radiation in previous 5 years
25. Personal or family history of multiple endocrine neoplasia type 2 (MEN-2) or familial thyroid carcinoma or non-familial medullary thyroid carcinoma
26. Have a pacemaker, metal implants, or aneurysm clips (exclusion only if doing MRI and CT scan)
27. Use of investigational drugs within 5 half-lives prior to screening
28. Participation to other intervention trials during the study period
29. Any comorbidities or medical conditions such as severe psychiatric disorder that make a person unfit for the study at the discretion of the investigators