Evaluation of the Performance of Contour Next® and Contour Plus Elite® BGMS in Arterial Blood Samples From Hospitalized Adults

Study Overview
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Brief Summary
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The purpose of the study is to extend the intended use of two BGMSs to include testing of arterial blood by Health Care Professionals (HCP) in a clinical setting.

Detailed Description
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This trial will evaluate the performance of both Contour Next BGMS and Contour Plus Elite BGMS using arterial blood from adult patients hospitalized in a Critical Care Unit (medical and surgical intensive care units (ICUs)). The investigational BGMS will be tested by a Point-of-Care (POC) operator in a clinical setting using residual arterial blood samples from adults who underwent prescribed arterial blood tests that were deemed necessary due to their medical conditions.

Official Title
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Evaluation of the Performance of Contour Next® and Contour Plus Elite® Blood Glucose Monitoring Systems (BGMS) in Arterial Blood Samples From Hospitalized Adults

Conditions
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Diabetes Mellitus

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are at least 18 years old. Residual Arterial blood samples collected from subjects hospitalized in a Critical Care Unit (medical and surgical intensive care units (ICUs)). Sample blood volume must be sufficient to complete investigational testing procedures clinical laboratory testing. Exclusion Criteria: - Residual arterial blood samples collected from subjects previously enrolled. and evaluated for this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

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: Device: Contour Next and Contour Plus Elite BGMS testing of arterial blood|The purpose of the study is to extend the intended use of two BGMSs to include testing of arterial blood by Health Care Professionals (HCP) in a clinical setting.|

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 |