Inpatient Closed Loop Glucose Control With the Gen 2 GlucoSTAT

NCT04227626 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-10-22

No results posted yet for this study

Summary

The goal of this study is to perform a first-in-humans trial of a fully integrated, automated, closed-loop blood glucose control system designed for inpatient use. The GlucoSTAT was designed for use by patients with diabetes while they are in the hospital, and others who may develop high blood sugar as a result of their medical problems.

Conditions

Interventions

DEVICE

GlucoSTAT

Closed-loop blood glucose control using intravenous insulin and dextrose

Sponsors & Collaborators

  • Beta Bionics, Inc.

    collaborator INDUSTRY
  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-30
Primary Completion
2021-04-30
Completion
2021-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

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 NCT04227626 on ClinicalTrials.gov