Inpatient Closed Loop Glucose Control With the Gen 2 GlucoSTAT
NCT04227626 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2020-10-22
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
- Type 1 Diabetes
- Type 2 Diabetes Treated With Insulin
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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