Assessing Accuracy of the Freestyle Libre Pro Glucose Monitoring in Patients With Diabetes in a Critical Care Setting

Summary

Currently, the standard of care for monitoring sugar levels in patients with diabetes in the intensive care unit is to use finger stick blood sugar monitoring. Finger stick blood sugar monitoring can be uncomfortable and time consuming. An alternate way to monitor sugar levels to use a sugar sensor, as part of the Abbott Freestyle Libre Flash glucose monitoring system, which has been approved for use outside of the hospital. The goal of the current research is to see whether using the sugar sensor gives accurate sugar readings in patients that are ill enough to be in the intensive care unit. If research confirms that the sensor is accurate, the investigators could potentially need to do fewer of those uncomfortable and time consuming blood sugar finger sticks.

At this time, the Freestyle Libre Flash Glucose Monitoring system is not available for purchase without a specific prescription for each individual patient and also is not available for purchase for research use from the manufacturer, Abbott Laboratories. However, the Freestyle Libre Pro sensor is available and uses the same measurement technology to measure interstitial glucose as the Libre Flash Glucose Monitoring system sensor (but does not require sensor scanning to retain glucose data). As such, the Libre Pro sensor will be utilized for the current study.

When a participant is enrolled in this study, they will have a Abbott Freestyle Libre Pro sensor applied to the back of their arm. They will continue to have finger stick glucoses checked as determined by their primary medical ICU team just as if they would if not enrolled in the study.

After the participant leaves the hospital, the data from their finger stick glucoses and from the Libre will be compared by a statistical analysis to see how similar or different the glucose readings from the finger stick glucoses are as compared to the Libre sensor data.

Conditions

• Diabetes Mellitus
• Critical Illness
• Continuous Glucose Monitoring

Interventions

DEVICE

Sensor

The FreeStyle Libre Pro sensor is a device whereby a sensor is inserted into subcutaneous tissue (upper arm) and measures the interstitial blood glucose which is then available for later download. It comes pre-calibrated meaning that no fingerstick glucose monitoring is required to improve accuracy of the sensor.

Sponsors & Collaborators

• University of Minnesota

  collaborator OTHER

• Hennepin Healthcare Research Institute

  lead OTHER

Principal Investigators

• Laura Lafave, MD · Hennepin County Medical Center, Minneapolis

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-06

Primary Completion

2021-09-21

Completion

2021-09-21

FDA Device

Yes

Countries

• United States

Study Locations