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

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Northwell Health

Status

Completed

Conditions

Diabetes Mellitus

Treatments

Device: Accuchek Inform II platform
Device: Freestyle Libre 14 day CGM system

Study type

Interventional

Funder types

Other

Identifiers

NCT04417270
20-0455

Details and patient eligibility

About

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.

Full 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.

Enrollment

52 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

52 participants in 2 patient groups

Freestyle Libre 14-day CGM
Other group
Description:
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.
Treatment:
Device: Freestyle Libre 14 day CGM system
Device: Accuchek Inform II platform
Accuchek Inform II meter
Other group
Description:
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
Treatment:
Device: Freestyle Libre 14 day CGM system
Device: Accuchek Inform II platform

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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