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

NCT05449795 | Completed Results FDA Device

• 1 other identifier: GCA-PRO-2021-004-01
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

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

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.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• \- Residual arterial blood samples collected from subjects previously enrolled. and evaluated for this study.

Sponsors & Collaborators

• Ascensia Diabetes Care: lead

Study Sites (1)

Royal Adelaide Hospital , ICU Research Unit

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Jane Wallace
• Organization: Ascensia Diabetes Care

jane.wallace@ascensia.com

5748501467

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: July 8, 2022
• Study Start: November 29, 2022
• Primary Completion: February 2, 2023
• Study Completion: April 20, 2023
• Last Updated: January 17, 2025
• Results First Posted: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)