GIP/GLP-1RA as Adjunctive to Automated Insulin Delivery in Adults With Type 1 Diabetes

What Was Tested

This registered phase 3 trial tested Tirzepatide.

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.

It had two arms (groups): Standard of Care (no intervention) and Standard of Care + Drug (experimental).

Participants in this arm will use their standard of care (SoC).

The registry classes the interventions as drug.

More on the Plan

However, randomized controlled trials (RCT) are still lacking.

This is a prospective, randomized, open-label design.

Who Took Part

Enrollment: 42 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. 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).

The full record lists 11 inclusion and 36 exclusion criteria; among the exclusions: history of diabetic ketoacidosis requiring hospitalization in the past six months; history of severe hypoglycemic event (level 3, defined as seizure or loss of consciousness) in the past six months; uncontrolled diabetic retinopathy or maculopathy.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Tirzepatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Tirzepatide study: the participants and staff both knew the treatment.

It started in 2025-02-14 with completion listed for 2026-06.

It ran at 3 sites in Switzerland (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change TIR (time frame: At week 16 of treatment).

It also tracked 8 secondary outcomes, for example Glycated Hemoglobin, CGM-measured TIR between 0700 and 2300 (TIR7-23) and 24/7 Total Daily Insulin (TDI).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Tirzepatide in 42 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page, all human trials.