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

Sponsor
Northwell Health (Other)
Overall Status
Completed
CT.gov ID
NCT04417270
Collaborator
(none)
52
Enrollment
1
Location
2
Arms
5.6
Actual Duration (Months)
9.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Freestyle Libre 14 day CGM system
  • Device: Accuchek Inform II platform
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
52 participants
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.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
Official Title:
Reliability of the Freestyle Libre CGM in the Inpatient Setting During the COVID-19 Surge
Actual Study Start Date :
Jun 12, 2020
Actual Primary Completion Date :
Nov 30, 2020
Actual Study Completion Date :
Nov 30, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lenox Hill Hospital New York New York United States 10022

Sponsors and Collaborators

  • Northwell Health

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Northwell Health
ClinicalTrials.gov Identifier:
NCT04417270
Other Study ID Numbers:
  • 20-0455
First Posted:
Jun 4, 2020
Last Update Posted:
Mar 2, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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

Study Results

No Results Posted as of Mar 2, 2021