The Insulin-Only Bionic Pancreas Bridging Study

What Was Tested

The trial (phase 2, phase 3) is built around Insulin Aspart and Insulin Lispro.

The iLet is a closed-loop delivery system that can be used in insulin-only, bihormonal, or glucagon-only configurations.

Previous studies have utilized a phone-based bionic pancreas.

The iLet consists of a touchscreen-enabled, menu-driven user interface and an onboard microprocessor that provides a comprehensive and standalone platform, which allows the iLet to operate independently of smartphones or other devices and without the need for internet support during routine operation.

It had three arms (groups): Adult RCT: Usual care (active comparator), Adult RCT: closed-loop control with iLet Humalog or Novolog (experimental) and Adult RCT: closed-loop control with iLet using Fiasp (experimental).

Participants randomized to usual care first started the usual care arm (UC) managing their diabetes with either multiple daily injections or continuous subcutaneous insulin infusion (pump therapy) for 7 days. All subjects wore a Dexcom G5 continuous glucose monitor (CGM) and half of all subjects also were a senseonics CGM. The usual care period was followed by the other 2 arms according to each subject's randomization schedule.

Participants randomized to the iLet with humalog/novolog first started the insulin-only iLet arm using the insulin analog that they use for their usual care (either Humalog or Novolog). All subjects wore a Dexcom G5 CGM and half of all subjects also wore a Senseonics Eversense CGM. The iLet period was followed by the other 2 arms according to each subject's randomization schedule.

The registry classes the interventions as device, drug and other.

More on the Plan

This study will serve as a transitional study, bridging to larger and longer outpatient pivotal studies using the insulin-only configuration of the bionic pancreas.

The Adult RCT Period will consist of a multi-center, three-period, random-order, cross-over, feasibility study in 36 adult participants ≥ 18 years old with T1D.

Half the subjects enrolled were expected to manage their diabetes with MDI and the other half with insulin pumps in their UC.

An implantable Eversense CGM will also be placed in half the study participants for a CGM comparison.

Who Took Part

The registry lists 36 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: Clinical diagnosis of type 1 diabetes for at least one year and using insulin for at least 1 year. Diabetes managed using an insulin pump for ≥ 3 months or with multiple daily injections (approximately 1/2 of participants should use a pump and approximately 1/2 should use MDI). Age ≥18 years;.

The full record lists 3 inclusion and 36 exclusion criteria; among the exclusions: for females, not currently known to be pregnant; an understanding of and willingness to follow the protocol and sign the informed consent and assent where applicable; the presence of any of the following is an exclusion for the study:.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Insulin Aspart and who got the comparison, which limits bias.

Each person switched between Insulin Aspart and the comparison at some point, usually with a gap in between.

Everyone knew when Insulin Aspart was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2018-07-09 with completion listed for 2018-11-19.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Mean CGM Glucose (time frame: Days 3-7 for the RCT Period).

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Insulin Aspart and Insulin Lispro in 36 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 Insulin Aspart compound page and the Insulin Lispro compound page, all human trials.