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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: Contour Next and Contour Plus Elite BGMS testing of neonatal blood


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 0 Days
Maximum Age: 27 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of results from the Contour Next and Contour Plus Elite BGMSs reference values within ±12.5% of reference values | 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). | 12 weeks | 
| Number of results from the Contour Next and Contour Plus Elite BGMSs reference values within ±20% of reference values | At least 98% of values should be within ±20% 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). | 12 weeks |