NCT05467345

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

Evaluation of the Performance of CONTOUR NEXT® and CONTOUR PLUS ELITE® Blood Glucose Monitoring Systems (BGMS) in Neonates Using Capillary Blood Samples

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 120 (actual)
• Sponsor: Ascensia Diabetes Care · Industry
• Sex: All
• Age: 0 Days – 27 Days
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Contour Next and Contour Plus Elite BGMS testing of neonatal blood	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.

Timeline

• Start date: 2022-08-24
• Primary completion: 2022-11-30
• Completion: 2023-03-14
• First posted: 2022-07-20
• Last updated: 2025-02-24
• Results posted: 2025-02-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study