NCT04417270

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Northwell Health · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-06-12
• Primary completion: 2020-11-30
• Completion: 2020-11-30
• First posted: 2020-06-04
• Last updated: 2021-03-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study