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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: Freestyle Libre 14 day CGM system; Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10022
      • Lenox Hill Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Freestyle Libre 14-day CGM; 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; 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.
Other: Accuchek Inform II meter; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Northwell Health
• Investigators: Principal Investigator: Renee Murray-Bachmann, Ed.D, MSN, Northwell Health

Publications and helpful links

Helpful Links

• 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
• 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

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2020
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: June 1, 2020
• First Submitted That Met QC Criteria: June 3, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): March 2, 2021
• Last Update Submitted That Met QC Criteria: March 1, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 20-0455

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The team has not decided whether to share the results with other researchers. The team will consider publishing results after study completion

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes