Evaluation of the Performance of CONTOU… | Clinical Trial

Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

0 day–27 day

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Louis Children's Hospital, Washington University

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Contour Next and Contour Plus Elite BGMS testing of neonatal blood

Device

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.

Primary outcomes

Number of Results From the Contour Next BGMSs Reference Values Within ±12.5% of Reference Values

Time frame: 1 day

At least 95% of all blood glucose results shall fall within ±12.5% of reference values (laboratory method) for glucose concentration ≥100 mg/dL(5.55 mmol/L )and within ±12 mg/dL(±0.67 mmol/L) at glucose concentrations <100 mg/dL(5.55 mmol/L).
Number of Results From the Contour Plus Elite BGMSs Reference Values Within ±12.5% of Reference Values

Time frame: 1 day

At least 95% of values should be within ±12.5% of reference values (laboratory method) for glucose concentration ≥75 mg/dL(4.16 mmol/L) and within ±15 mg/dL(±0.83 mmol/L) at glucose concentrations < 75 mg/dL(4.16 mmol/L).

Sponsors and collaborators

Lead sponsor

Ascensia Diabetes Care

Industry

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2023
First posted: Jul 20, 2022
Registry last updated: Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed