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

NCT ID: NCT05449795

Last Updated: 2025-01-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-29

Study Completion Date

2023-04-20

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.

Conditions

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Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ascensia Diabetes Care

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Royal Adelaide Hospital , ICU Research Unit

Adelaide, South Australia, Australia

Site Status

Countries

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Australia

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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GCA-PRO-2021-004-01

Identifier Type: -

Identifier Source: org_study_id

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