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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05449795




Registration number
NCT05449795
Ethics application status
Date submitted
5/07/2022
Date registered
8/07/2022
Date last updated
27/07/2023

Titles & IDs
Public title
Evaluation of the Performance of Contour Next® and Contour Plus Elite® BGMS in Arterial Blood Samples From Hospitalized Adults
Scientific title
Evaluation of the Performance of Contour Next® and Contour Plus Elite® Blood Glucose Monitoring Systems (BGMS) in Arterial Blood Samples From Hospitalized Adults
Secondary ID [1] 0 0
GCA-PRO-2021-004-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Device: Contour Next and Contour Plus Elite BGMS testing of arterial blood

Treatment: Devices: 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 code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of results from the Contour Next and Contour Plus Elite BGMSs reference values within ±12.5% of reference values
Timepoint [1] 0 0
12 weeks
Primary outcome [2] 0 0
Number of results from the Contour Next and Contour Plus Elite BGMSs reference values within ±20% of reference values
Timepoint [2] 0 0
12 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Residual arterial blood samples collected from subjects previously enrolled. and
evaluated for this study.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/04/2023
Sample size
Target
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital , ICU Research Unit - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Ascensia Diabetes Care
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05449795
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries