Evaluation of the Performance of CONTOUR NEXT® and CONTOUR PLUS ELITE® BGMS in Neonates Using Capillary Blood Samples

Ascensia Diabetes Care

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Device: Contour Next and Contour Plus Elite BGMS testing of neonatal blood

Study type: Observational

Funder types: Industry

Identifiers

NCT05467345

GCA-PRO-2021-003-01

Details and patient eligibility

About

The purpose of this study is to extend the intended use of two BGMSs to include testing of neonatal blood by Health Care Professionals in a clinical setting for the quantitative measurement of glucose levels in neonates.

Full description

This trial will evaluate the performance of both the CONTOUR NEXT BGMS and CONTOUR PLUS ELITE BGMS using blood from neonates within a hospital ward, e.g. routine/newborn nurseries, Special Care Nurseries, Neonatal Intensive Care Unit (NICU). The investigational BGMSs will be tested by a Point-of-Care operator using residual heel-stick capillary blood samples from neonates who underwent routine prescribed testing.

Enrollment: 120 patients

Sex: All

Ages: Under 27 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Residual capillary (heel-stick) blood samples from neonates (less than 28 days of age) after birth as part of prescribed testing.
• Sample blood volume must be sufficient to complete investigational testing in addition to routine prescribed clinical laboratory testing.

Exclusion criteria

• Samples from subjects who are ≥ 28 days of age.
• Samples from subjects who have previously been enrolled into this study.

Trial design