MedTrace Logo

Glucose Time-In-Range Development Evaluation

NCT03670017 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2021-10-19

Study results available
· View outcomes & findings →

Summary

The study will evaluate patients requiring frequent glucose monitoring in a Surgical ICU. The study population includes surgical critical care patients who require blood glucose monitoring. Subjects must have a vascular access device \[i.e., Central Venous Catheters (CVC), Multi-lumen Access Catheters (MAC) either in place or to be placed with an expected usage of at least 48 hours. During Phase One of the trial, patients will be connected to the OptiScanner for up to 72 hours and the hospital's current standard of care for glucose management will be followed.

Conditions

  • ICU
  • Dysglycemia

Interventions

DEVICE

OptiScanner® 5000 Glucose Monitoring System

The study population includes surgical critical care patients who require blood glucose monitoring. Subjects must have a vascular access device \[i.e., Central Venous Catheters (CVC), Multi-lumen Access Catheters (MAC) either in place or to be placed with an expected usage of at least 48 hours. During Phase One of the trial, patients will be connected to the OptiScanner for up to 72 hours and the hospital's current standard of care for glucose management will be followed.

Sponsors & Collaborators

  • OptiScan Biomedical Corporation

    collaborator INDUSTRY

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Grant Bochicchio, MD MPH · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-06
Primary Completion
2020-09-04
Completion
2020-09-04
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03670017 on ClinicalTrials.gov