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Individualizing Automated Closed Loop Glucose Control Through Pharmacokinetic Profiling in an Insulin-Only Bionic Pancreas

NCT03262116 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-12-09

Study results available
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Summary

Subjects will participate in three weeks of the bionic pancreas in the insulin-only configuration. Each week, subjects will use a different rapid acting insulin analog -- Humalog, Novolog, or BC222 insulin lispro -- in a randomized cross-over order.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

Humalog

Subjects will participate in one week of wearing the insulin only bionic pancreas using humalog as the rapid acting insulin.

DRUG

Novolog

Subjects will participate in one week of wearing the insulin only bionic pancreas using novolog as the rapid acting insulin.

DRUG

BC222 insulin lispro

Subjects will participate in one week of wearing the insulin only bionic pancreas using BC222 insulin lispro as the rapid acting insulin.

DEVICE

Bionic Pancreas

The insulin-only bionic pancreas will be used in all three arms of the study

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
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-19
Primary Completion
2019-07-23
Completion
2019-07-23
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03262116 on ClinicalTrials.gov