The Insulin-Only Bionic Pancreas Pivotal Trial

Summary

This multi-center randomized control trial (RCT) will compare efficacy and safety endpoints using the insulin-only configuration of the iLet Bionic Pancreas (BP) System versus Usual Care (UC) during a 13-week study period. 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. At the completion of use of the BP system in the RCT only, participants will enter a 2-4 day Transition Phase and be randomly assigned to either transition back to their usual mode of therapy (MDI or pump therapy) based on therapeutic guidance from the iLet BP System or transition back to their usual mode of therapy based on what their own insulin regimens were prior to enrolling in the RCT.

There is an optional ancillary study to assess the safety of utilizing self-monitored blood glucose (SMBG) measurements instead of continuous glucose monitor (CGM) measurements as input into the iLet for \~48-60 hours. The Study is intended to mirror a real-world situation where CGM may not be available for an extended period of time (eg, user runs out of sensors and is awaiting new shipment).

Conditions

• Diabetes Mellitus
• Type 1 Diabetes
• Diabetes Mellitus, Type 1

Interventions

COMBINATION_PRODUCT

Bionic Pancreas (BP) with Aspart or Lispro

iLet Bionic Pancreas System, which consists of an integrated infusion pump, touchscreen display, Bluetooth radio, and insulin dosing algorithms, that automatically controls insulin delivery based on glucose values obtained by communicating with a Dexcom G6 sensor using lispro or aspart insulin.

COMBINATION_PRODUCT

Bionic Pancreas with Fiasp (BPFiasp)

iLet Bionic Pancreas System, which consists of an integrated infusion pump, touchscreen display, Bluetooth radio, and insulin dosing algorithms, that automatically controls Fiasp insulin delivery based on glucose values obtained by communicating with a Dexcom G6 sensor.

OTHER

Usual Care (UC)

Using pre-study insulin regimen with the Dexcom G6 CGM

OTHER

BP Guidance Insulin Dosing

Pre-study insulin delivery method with SMBG and blinded CGM with dosing guidance by the BP

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• Beta Bionics, Inc.

  collaborator INDUSTRY

• Boston University

  collaborator OTHER

• Massachusetts General Hospital

  collaborator OTHER

• Jaeb Center for Health Research

  lead OTHER

Principal Investigators

• R. Paul Wadwa, MD · University of Colorado, Denver

• Mark Daniels, MD · Children's Hospital of Orange County

• Fran Cogen, MD · Children's National Research Institute

• Keren Zhou, MD · The Cleveland Clinic

• Andrew Muir, MD · Emory University

• Davida Kruger, NP · Henry Ford Health System

• Steven J Russell, MD · Massachusetts General Hospital

• Robin Goland, MD · Naomi Berrie Center - Columbia University

• Nelly Mauras, MD · Nemours Children's Health System

• Bruce Buckingham, MD · Stanford University

• Jeremy Pettus, MD · UC-San Diego

• John Buse, MD · University of North Carolina, Chapel Hill

• Irl Hirsch, MD · University of Washington

• Jane Lynch, MD · UT Health Science Center - San Antonio

• Perrin White, MD · University of Texas, Southwestern Medical Center at Dallas

• Janet McGill, MD · Washington University School of Medicine

• Jill Weissberg-Benchell, PhD · Lurie Children's Hospital

• Roy Beck, MD, PhD · Jaeb Center for Health Research

• Katrina Ruedy, MSPH · Jaeb Center for Health Research

• Philip Raskin, MD · UT Southwestern

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-03-31

Primary Completion

2021-10-30

Completion

2022-01-14

FDA Device

Yes

Countries

• United States

Study Locations