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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: Freestyle Libre 14 day CGM system
* Device: Accuchek Inform II platform


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Freestyle Libre 14-day CGM<br>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: Freestyle Libre 14 day CGM system<br>* 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.<br>Device: Accuchek Inform II platform<br>* 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.<br>|
| Other: Accuchek Inform II meter<br>ACCU-CHEK INFORM II system quantitatively measures glucose in fresh venous, arterial, neonatal heel stick and capillary whole blood from the finger and is used as an aid in monitoring the effectiveness of glucose control | Device: Freestyle Libre 14 day CGM system<br>* 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.<br>Device: Accuchek Inform II platform<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of values between two devices | Correlation between blood glucose results from the Freestlye Libre 14-day CGM and Accuchek Inform II platform using the Bland-Altman method to determine whether the two glucose methods agree | Through end of patient hospitalization, an average of 14 days |