NCT05449795

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 120 (actual)
• Sponsor: Ascensia Diabetes Care · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-11-29
• Primary completion: 2023-02-02
• Completion: 2023-04-20
• First posted: 2022-07-08
• Last updated: 2025-01-17
• Results posted: 2025-01-17

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated device study