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

Ascensia Diabetes Care

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Device: Device: Contour Next and Contour Plus Elite BGMS testing of arterial blood

Study type: Observational

Funder types: Industry

Identifiers

NCT05449795

GCA-PRO-2021-004-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design