Official Title
Reliability of the Freestyle Libre CGM in the Inpatient Setting During the COVID-19 Surge
Brief 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.

Detailed Description

In hospitalized patients diagnosed with COVID-19, diabetes mellitus is associated with a
higher mortality. Patients with controlled blood glucose have a lower mortality rate than
those who are uncontrolled. However, a rigid blood glucose control - which may lead to
hypoglycemia- is associated with higher mortality rates. Thus, adequate glucose monitoring is
important for hospitalized diabetic patients.

Previous studies have shown that CGMS, in the outpatient setting, engender better glycemic
control thereby reducing risk of hypoglycemia. CGMS offer a replacement for finger stick
blood glucose monitoring which may not identify an incidence of hypoglycemia until symptoms
drive the patient to test. Furthermore, finger stick blood glucose monitoring is painful and
time consuming thus causing many patients to avoid this aspect of diabetes self-care
management.

Freestyle Libre CGMs sample interstitial fluid glucose subcutaneously. Measurement
frequencies typically range from 1 to 15 minutes and most commonly are every 5 minutes.

Previous studies in hospitalized patients living with diabetes mellitus on basal bolus
regimen have shown:

• Use of the CGM increased detection of both hypoglycemic and hyperglycemic events versus
those sensed by POCT.

One investigation identified 88 postprandial hyperglycemic excursions in patients with CGM
use as opposed to 61 in those with POCT. Another noted that when comparing the CGM use with
that of POCT, the former identified 55 hypoglycemic events whereas the latter only found 12.

• No difference in mean daily glucose CGM and POCT readings. In a study of 38 patients, the
investigators noted no difference in mean daily glucose between the CGM and POCT.

Completed
Diabetes Mellitus

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.

Eligibility Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- Minors, pregnant women, and critically ill.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 99 Years
Countries
United States
Locations

Lenox Hill Hospital
New York, New York, United States

Renee Murray-Bachmann, Ed.D, MSN, Principal Investigator
Northwell Health

Northwell Health
NCT Number