Pilot Study of Intensive Care Unit Continuous Glucose Monitoring

Summary

The investigators believe that there remains a gap in implementing insulin infusions in critically ill patients to maximize the benefit and minimize adverse events like episodes of hypoglycemia. Based on the published experience with Continuous Glucose Monitor (CGM), the investigators believe that it is safe to use in critically ill patients. Furthermore, the investigators believe that in combination with a protocol with low risk for hypoglycemia at baseline, that CGM can eliminate this risk fully.

In this study the investigators will:

1. Study the safety and feasibility of the continuous glucose monitor use in 20 critically ill patients for 7 days (the current maximum recommendation for sensor use). Safety data will include the rate of significant bleeding (hematoma) or infection (cellulitis) from sensor use. Feasibility data will evaluate the amount of missing glucose data over the 7-day sensor life.
2. Randomize patients treated with the current UVA intensive care insulin protocol for insulin management to the addition of "brakes" that reduce insulin administration based on continuous glucose monitoring data between hourly reference glucose data to prevent episodes of hypoglycemia (blood glucose \<70 mg/dl) and severe hypoglycemia (blood glucose \<50 mg/dl). This will serve as pilot data to power a larger study in the future.

Conditions

• Hyperglycemia
• Hypoglycemia

Interventions

OTHER

Current UVA intensive care insulin protocol

Current UVA intensive care insulin protocol used for insulin management for 12 hours

OTHER

Current UVA intensive care insulin protocol with "brakes"

Current UVA intensive care insulin protocol for insulin management with the addition of "brakes" which reduces insulin administration based on continuous glucose monitoring data between hourly reference glucose data to reduce episodes of hypoglycemia (blood glucose \<70 mg/dl)and severe hypoglycemia (blood glucose\<50 mg/dl).

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command

  collaborator FED

• University of Texas

  collaborator OTHER

• University of Virginia

  lead OTHER

Principal Investigators

• Stacey Anderson, MD · University of Virginia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-02-28

Primary Completion

2013-09-30

Completion

2013-09-30

Countries

• United States

Study Locations