GIP/GLP-1RA as Adjunctive to Automated Insulin Delivery in Adults With Type 1 Diabetes: A Prospective, Randomized, Clinical Study - The AID-JUNCT Trial
Blood glucose management in type 1 diabetes (T1D) remains a challenge, with only \ 30% of adults within the recommended consensus guidelines. Novel drugs like glucagon-like peptide-1 receptor agonists (GLP-1RAs) and glucose-dependent insulinotropic polypeptide (GIP)/GLP-1RAs have emerged as promising add-ons to insulin in T1D. This application has been designed to test in a prospective study whether adding a new medicine called tirzepatide (GIP/GLP-1RA) to the usual insulin therapy would make a difference for people with T1D in terms of better glucose control.
• Participants with diagnosed T1D for at least 12 months.
• Aged between 18 to 65 years old (inclusive).
• Currently on AID therapy for at least three months.
• HbA1C higher or equal to 6.5% and less or equal to 10%.
• BMI ≥23 kg/m2.
• Willing to use once-weekly tirzepatide for at least 16 weeks (including four weeks of up-titration and 12 weeks of treatment)
• Willing to wear a Dexcom G7 Sensor and share devices (AID) data uploads.
• Willingness not to start any new non-insulin glucose-lowering agent during the trial (including metformin/biguanides, pramlintide, DPP-4 inhibitors, sodium-glucose cotransporter 2 inhibitors \[SGLT2 inhibitors\], and nutraceuticals).
• A stable weight (± 5%) in the last 90 days or more before the screening and agree to not initiate a diet and/or exercise program during the study to reduce body weight other than the lifestyle and dietary measures for diabetes treatment.
⁃ Females with childbearing potential and males (if apply) must be willing to use reliable contraceptive methods (for the contraceptives study guidelines. See Annex 7 of the protocol)
⁃ An understanding and willingness to follow the protocol and signed informed consent.