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

NCT04417270 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2021-03-02

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Freestyle Libre 14 day CGM system

The FreeStyle Libre 14 day system is a continuous glucose monitoring system consisting of a handheld reader and a sensor worn on the back of the upper arm.

DEVICE

Accuchek Inform II platform

The Accu-Chek Inform II system is designed to deliver data with speed and efficiency, helping to provide optimal care. Wireless meter quickly transfers data. The Accu-Chek Inform II system is the first point-of-care blood glucose device to offer truly wireless technology at the meter level.

Sponsors & Collaborators

  • Northwell Health

    lead OTHER

Principal Investigators

  • Renee Murray-Bachmann, Ed.D, MSN · Northwell Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-12
Primary Completion
2020-11-30
Completion
2020-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04417270 on ClinicalTrials.gov