The Bihormonal iLet Bionic Pancreas Feasibility Study

What Was Tested

This registered phase 2, phase 3 trial tested Glucagon.

Their objective is to evaluate the function of the bihormonal configuration of the ILet bionic pancreas delivering dasiglucagon when compared to the insulin-only configuration of the ILet bionic pancreas in a home-use study in adults with type 1 diabetes.

It had two arms (groups): Bihormonal iLet first, then Insulin-Only iLet (experimental) and Insulin-Only iLet first, then Bihormonal iLet (experimental).

The registry classes the interventions as device and drug.

More on the Plan

The study will assess the safety and reliability of both iLet configurations.

Their secondary objective is to assess the impact of both configurations of the Gen 3.2 iLet bionic pancreas system on glycemic control, quality of life, and treatment satisfaction among study participants, their caregivers, partners, and/or family members.

The study follows a 2-treatment, 2-period crossover design, 2 and will consist of two 7-day study arms in random order: one bihormonal bionic pancreas arm using insulin lispro or insulin aspart and dasiglucagon, and one insulin-only bionic pancreas arm using insulin lispro or insulin aspart.

Who Took Part

The registry lists 12 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Age ≥ 18 years and have had clinical type 1 diabetes for at least one year. Diabetes managed using an insulin pump for ≥ 3 months. Have used a CGM for at least one cumulative month over the last 24 months. Willing to stay within a 250-mile radius of the designated base throughout the study. Air travel is not permitted. Informed consent obtained before any trial-related activities.

The full record lists 8 inclusion and 35 exclusion criteria; among the exclusions: unable to provide informed consent (e.g. impaired cognition or judgment); current participation in another clinical trial with administration of investigational drug; previous exposure to dasiglucagon (otherwise known as zp4207).

How the Study Was Run

It was run as a randomized, crossover and open-label study.

Because people in this Glucagon 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 Glucagon and the comparison in turn, acting as their own control.

Being open-label, the Glucagon study did not mask who received what.

It started in 2019-05-15 with completion listed for 2019-07-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage of Time That Valid CGM Glucose Readings Are Captured by the iLet Bionic Pancreas (time frame: Days 1-7). Percentage of Time That Each Drug Channel of the iLet Bionic Pancreas is Available (time frame: Days 1-7).

It also tracked 4 secondary outcomes, for example Mean Continuous Glucose Monitor Glucose Concentration.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Glucagon in 12 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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