Feasibility Trial Testing the Bionic Pancreas With ZP4207

PHASE2CompletedINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

November 30, 2016

Primary Completion Date

May 24, 2017

Study Completion Date

June 7, 2017

Conditions
Diabetes Mellitus, Type 1
Interventions
DRUG

Insulin Lispro

Used to lower blood glucose. Commercially available by prescription and is indicated for patients with type 1 diabetes mellitus (T1DM), but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.

DRUG

ZP4207 (dasiglucagon)

A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.

DRUG

Glucagon

A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.

DEVICE

iPhone-based bionic pancreas

An experimental device.

DEVICE

iLet-based bionic pancreas

An experimental device.

Trial Locations (1)

02114

MGH Diabetes Center, Boston

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Massachusetts General Hospital

OTHER

collaborator

Beta Bionics, Inc.

INDUSTRY

lead

Zealand Pharma

INDUSTRY