Reliability of the Freestyle Libre CGM in the Inpatient Setting During the COVID-19 Surge
Condition: Diabetes Mellitus
Study type: Interventional

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.
    

Intervention name(s): Freestyle Libre 14 day CGM system; Accuchek Inform II platform
Intervention type(s): Device; Device
Intervention description(s): 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.; 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.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Patients will use the Freestyle 14 day CGM reader or their phone to check their glucose. A clinical staff member will check the patient's blood sugar by performing a glucose finger stick with the Accuchek inform II meter.
Masking: None (Open Label)
Primary purpose: Other