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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05449795
Registration number
NCT05449795
Ethics application status
Date submitted
5/07/2022
Date registered
8/07/2022
Date last updated
25/03/2025
Titles & IDs
Public title
Performance of Contour Next® and Contour Plus Elite® BGMS in Arterial Blood Samples From Hospitalized Adults
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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
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Secondary ID [1]
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GCA-PRO-2021-004-01
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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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.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Results From the Contour Next BGMSs Reference Values Within ±12.5% of Reference Values
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Assessment method [1]
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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).
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Timepoint [1]
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1 day
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Primary outcome [2]
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Number of Results From the Contour Plus Elite BGMSs Reference Values Within ±12.5% of Reference Values
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Assessment method [2]
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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).
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Timepoint [2]
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1 day
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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.
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Minimum age
18
Years
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Maximum age
100
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Residual arterial blood samples collected from subjects previously enrolled. and evaluated for this study.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
29/11/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
20/04/2023
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Sample size
Target
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Accrual to date
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Final
120
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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Royal Adelaide Hospital , ICU Research Unit - Adelaide
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Ascensia Diabetes Care
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT05449795
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/95/NCT05449795/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/95/NCT05449795/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT05449795
Download to PDF