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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04417270
• Other study ID #: 20-0455
• Status: Completed
• Phase: N/A
• Start date: June 12, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: March 2021
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Lenox Hill Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Continuous Glucose Monitoring in the Hospital Panel (2017). Consensus Statement on Inpatient Use of Continuous Glucose Monitori
•   Flash Glucose-Sensing Technology as a Replacement for Blood Glucose Monitoring for the Management of Insulin-Treated Type 2 Diabetes: A Multicenter, Open-Label Randomize
•   Hoss, U., Budiman, E. S., Liu, H., & Christiansen, M. P. (2014). Feasibility of Factory Calibration for Subcutaneous Glucose Sensors in Subjects with Diabetes. Journal of diabetes science and technology, 8(1), 89-94.
•   Rebrin, K., Sheppard, N. F., Jr, & Steil, G. M. (2010). Use of subcutaneous interstitial fluid glucose to estimate blood glucose: revisiting delay and sensor offset. Journal of diabetes science and technology, 4(5), 1087-1098.
•   Zhu, L., Zhi-Gang, S., Cheng, S., Guo, J., Bing-Hong, Z.,Hongliang, L. (2020).Association of blood glucose control and outcomes in patients with COVID-19 and pre-existing Type 2 Diabetes Cell Metabolism, 31, (2020).pp.1-10