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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: Device: Contour Next and Contour Plus Elite BGMS testing of arterial blood

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital , ICU Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 96 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

- The subject population will consist of adults who are hospitalized in a Critical Care Unit, (medical and surgical intensive care units (ICUs)) at the Investigational site.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Results From the Contour Next 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).	1 day
Number of Results From the Contour Plus Elite BGMSs Reference Values Within ±12.5% of Reference Values	At least 98% 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).	1 day

Collaborators and Investigators

• Sponsor: Ascensia Diabetes Care

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2022
• Primary Completion (Actual): February 2, 2023
• Study Completion (Actual): April 20, 2023

Study Registration Dates

• First Submitted: July 5, 2022
• First Submitted That Met QC Criteria: July 5, 2022
• First Posted (Actual): July 8, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 16, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus
• Other Study ID Numbers: GCA-PRO-2021-004-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No