Reliability of the Freestyle Libre CGM in the Inpatient Setting During the COVID-19 Surge

Completed · Not applicable

Conditions studied: Diabetes Mellitus

In brief

The FDA has provided an emergency waiver for the use of non-invasive continuous glucose monitors (CGM) in hospitals, so frontline health care providers (in hospitals) can remotely monitor patients with diabetes thus reducing patient's discomfort, limiting exposure to COVID-19 and preserving critical personal protective equipment (PPE). The FreeStyle Libre 14-day system is a continuous glucose monitoring system consisting of a handheld reader (smart phone may be used) and a sensor applied with adhesive to back of the upper arm. In order to evaluate the reliability of the Freestyle Libre CGM for in-patient use, we propose a study which will examine the correlation between the libre CGM data and capillary blood glucose test - the current standard of care taken by the Accuchek Inform II platform.

Key facts

Study ID

NCT04417270

Run by

Northwell Health

People needed

52

Starts

2020-06-12

Expected to finish

2020-11-30

Last updated by the study team

2021-03-02

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants acquired from among all non-critical care in patients who are living with Diabetes Mellitus. Because the patients will have to be instructed on the use of the CGM, this study will be limited to English speaking/reading adults (18 years of age or older), who possess the cognitive and physical ability to participate.

You may not qualify if…

• Minors, pregnant women, and critically ill.

Where it is running

• Lenox Hill Hospital — New York, New York, United States

Full record on ClinicalTrials.gov

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