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An Outpatient Study of Automated Blood Glucose Control With an Insulin-Only Bionic Pancreas

NCT02536950 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2018-06-21

No results posted yet for this study

Summary

This is an open-label, non-randomized, pilot study to determine the safety and feasibility of the insulin-only bionic pancreas.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DEVICE

Fixed set point

Fixed set point arm: A fixed setpoint will be used initially. Staff will observe glucose control over 2 days while subjects remain in a hotel environment, and then over 5 more days in the same subjects in an outpatient setting. The clinical staff will adjust this target up or down by 15 mg/dl based on their glycemic control in the hotel setting.

DEVICE

Variable set point

Variable set point arm: The setpoint will be variable over a 30 mg/dl range and glycemic control will be optimized based on the preceding 24-hour window.

Sponsors & Collaborators

  • Boston University

    collaborator OTHER

  • Massachusetts General Hospital

    collaborator OTHER

  • Bruce A. Buckingham

    lead OTHER

Principal Investigators

  • Bruce A Buckingham, MD · Stanford School of Medicine, Pediatric Endocrinology

Study Design

Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-07-31
Completion
2016-07-31

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 NCT02536950 on ClinicalTrials.gov