The iLet Introduction Study: A Feasibility Study of the iLet, a Fully Integrated Bihormonal Bionic Pancreas

Summary

This study will compare two different models of a wearable bionic pancreas device (the iPhone-based bionic pancreas vs. the iLet bionic pancreas) in adult participant with type 1 diabetes. Both bionic pancreas devices measure glucose levels every five minutes and then give insulin and/or glucagon automatically to regulate the blood glucose (BG).

Conditions

• Diabetes Mellitus Type 1

Interventions

DEVICE

iPhone bionic pancreas

An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps

DEVICE

iLet bionic pancreas

An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.

DRUG

Xeris Xerisol glucagon

A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump

DRUG

Lilly glucagon

An aqueous formulation of human glucagon with limited stability that must be changed daily

DEVICE

iLet infusion set

The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.

DEVICE

Contact Detach infusion set

The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.

Sponsors & Collaborators

• Boston University

  collaborator OTHER

• Massachusetts General Hospital

  lead OTHER

Principal Investigators

• Steven J Russell, MD, PhD · Massachusetts General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-03-31

Primary Completion

2018-05-31

Completion

2018-05-31

FDA Device

Yes

Countries

• United States

Study Locations