Alleviating Carbohydrate Counting for Patients with Type-1 Diabetes Using a Closed Loop System with Weekly Subcutaneous Semaglutide

What Was Tested

The trial (phase 2, phase 3) is built around Semaglutide.

Yet, despite these advantages, certain challenges persist.

It had two arms (groups): Weekly placebo injections on regular closed-loop insulin pump therapy (active comparator) and Weekly semaglutide (Ozempic®) injections on regular closed-loop insulin pump therapy (experimental).

The registry classes the interventions as drug.

More on the Plan

Eliminate carbohydrate counting and any meal announcement (i.e fully closed-loop) in people with T1D on closed-loop therapy without degrading glucose control. 2.

Participants will be asked to undergo two subsequent blinded drug interventions; one with semaglutide and the other with placebo.

Both interventions include 4 meal strategies each with a 3-week duration; full carbohydrate counting with rapid-acting insulin, SMA with rapid-acting insulin, SMA with Lyumjev and fully closed-loop system with Lyumjev.

Who Took Part

Enrollment: 26 planned participants were the target.

It was open to people of any sex.

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

Examples of who could join: At least 18 years of age.

The full record lists 3 inclusion and 15 exclusion criteria; among the exclusions: use of glp1-ras within the last 4 weeks; use of any anti-hyperglycemic agent other than insulin within the last 2 weeks; planned or ongoing pregnancy.

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

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

In the crossover set-up each of the participants took both Semaglutide and the comparison in turn, acting as their own control.

Blinding on both sides kept the participants and researchers unaware of who received Semaglutide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2024-12-01 with completion listed for 2027-01.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of daytime plasma glucose levels spent in target range (semaglutide vs. placebo) (time frame: 24 weeks).

It also tracked 20 secondary outcomes, for example Mean glucose level, Standard deviation of glucose levels as a measure of glucose variability, Percentage coefficient of variation of glucose levels, Glycated hemoglobin (HbA1c), Area under the curve 0-2h post meal, 0-3h post peal and Average scores between interventions on the Type 1 Diabetes Distress Scale questionnaire.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Semaglutide in 26 people.

Its size is small, so on its own it can only give an early look.

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

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