Reliability of the Freestyle Libre CGM in the Inpatient Setting During the COVID-19 Surge
- Conditions
- Diabetes Mellitus
- Interventions
- Device: Freestyle Libre 14 day CGM systemDevice: Accuchek Inform II platform
- Registration Number
- NCT04417270
- Lead Sponsor
- Northwell Health
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- 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.
- Minors, pregnant women, and critically ill.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Freestyle Libre 14-day CGM 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. Freestyle Libre 14-day CGM Accuchek Inform II platform 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. Accuchek Inform II meter Freestyle Libre 14 day CGM system 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 Accuchek Inform II meter Accuchek Inform II platform 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
- Primary Outcome Measures
Name Time Method Comparison of values between two devices Through end of patient hospitalization, an average of 14 days 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Lenox Hill Hospital
🇺🇸New York, New York, United States