The Insulin-Only Bionic Pancreas Pivotal Trial

What Was Tested

In this not phased trial, researchers set out to test Insulin Aspart and Insulin Lispro.

Participants may be enrolled initially into a screening protocol and then transfer into the RCT protocol, or they may enter directly into the RCT protocol.

The RCT will be followed by an Extension Phase in which the RCT Usual Care (UC) Group will use the insulin-only configuration of the iLet Bionic Pancreas (BP) System for 3 months.

It had six arms (groups): Bionic Pancreas (BP) (experimental), Bionic Pancreas with Fiasp (BPFiasp) (experimental), Usual Care (UC) (other), Bionic Pancreas Extension (experimental) and Transition Phase - BP Guidance (experimental).

Some adults and 1/2 peds will be randomized to use the Bionic Pancreas (BP) with lispro or aspart for 13 weeks.

Some adults will be randomized to use the Bionic Pancreas (BP) with Fiasp for 13 weeks during RCT.

The registry classes the interventions as combination product and other.

More on the Plan

Secondary Objectives • To assess the impact of the insulin-only configuration of the iLet BP System on quality of life and treatment satisfaction.

The study has four major parts: (1) the Test-Run Phase, (2) the RCT Period, (3) the Extension Phase for the UC Arm, and (4) the Transition Phase.

These four parts are described below, and detailed in the main part of the protocol.

A Test-Run Phase will be conducted to (1) test the functionality of all aspects of the iLet BP System, (2) train the clinical staff on the execution of the clinical protocol, and (3) provide hands-on training with the device prior to initiating the RCT Period.

Who Took Part

The registry lists 440 actual participants took part.

It was open to people of any sex aged from 6 years with no upper age limit.

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

Examples of who could join: Exception: the initial 5-participant test run will be limited to \>18 years old.

The full record lists 3 inclusion and 27 exclusion criteria; among the exclusions: unable to provide informed consent (e.g. impaired cognition or judgment); unable to speak and read english; current use of non-fda approved closed-loop or hybrid closed-loop insulin delivery system.

How the Study Was Run

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

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

The Insulin Aspart group and the comparison group ran side by side rather than switching.

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

It started in 2020-03-31 with completion listed for 2021-10-30.

It ran at 16 sites in United States (16).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): HbA1c (time frame: 13 weeks).

It also tracked 45 secondary outcomes, for example CGM-measured Mean Glucose Level Over 13 Weeks, CGM-measured Glucose Standard Deviation (SD) mg/dL Over 13 Weeks and CGM-Measured Glucose Coefficient of Variation Over 13 Weeks.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Aspart and Insulin Lispro in 440 people.

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

More context: the Insulin Aspart compound page and the Insulin Lispro compound page, all human trials.