The Insulin-Only Bionic Pancreas Bridging Study- Pediatric Transitional Study

What Was Tested

The trial (not phased) 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 two arms (groups): Usual care (active comparator) and iLet Bionic Pancreas with Humalog or Novolog (experimental).

Participants randomized to usual care first started the usual care arm (UC) managing their diabetes with continuous subcutaneous insulin infusion (pump therapy) for approximately 5 days. All subjects wore a Dexcom G5 continuous glucose monitor (CGM). If randomized to the usual care arm first, subjects crossed over to the bionic pancreas arm following a 2-day washout period.

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) for approximately 5 days. All subjects wore a Dexcom G5 CGM. If randomized to the bionic pancreas arm first, subjects crossed over to the usual care arm following a 2-day washout period.

The registry classes the interventions as device and other.

More on the Plan

The two experimental periods will each span 5 days, including 4 nights (e.g.

A washout period of \~ 3 days in duration will separate the two experimental periods of the Pediatric Transitional Study Session.

Both study periods will be conducted in the same clinically supervised setting during each of the 5 days and at home under parental supervision or other overnight companion who is available to serve as an emergency contact during each of the 4 nights.

Parents/guardians must be present (i.e. in the house or building) while the participant is home and sleeping and will serve as the contact person for overnight alerts.

Who Took Part

20 actual participants took part.

It was open to people of any sex aged from 6 years up to 17 years.

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. Age 6-17 years. At least 3 SMBG meter tests daily on average or use of a CGM and 2 or more SMBG meter tests daily on average by history. For females, not currently known to be pregnant.

The full record lists 7 inclusion and 32 exclusion criteria; among the exclusions: the presence of any of the following is an exclusion for the study:; unable to provide informed consent (e.g. impaired cognition or judgment); unable to speak and read english.

How the Study Was Run

Design: randomized, crossover and open-label.

The participants were allocated by chance, so the Insulin Aspart group and the comparison group should start out alike.

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

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

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

The main thing measured (primary outcome): Mean CGM Glucose (time frame: Days 2-5).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Aspart and Insulin Lispro in 20 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.