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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05449795
• Other study ID #: GCA-PRO-2021-004-01
• Status: Completed
• Start date: November 29, 2022
• Est. completion date: April 20, 2023

Study information

• Verified date: July 2023
• Source: Ascensia Diabetes Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 20, 2023
• Est. primary completion date: February 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital , ICU Research Unit	Adelaide	South Australia

Sponsors (1)

Lead Sponsor	Collaborator
Ascensia Diabetes Care

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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