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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
- Residual arterial blood samples collected from subjects previously enrolled. and evaluated for this study.
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- 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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Adelaide Hospital , ICU Research Unit | Adelaide | South Australia | 5000 | Australia |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arterial Blood Results | Samples collected and tested in duplicate by BGMS and compared to laboratory results |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
120 participants were enrolled in the study. Each participant provided two blood samples that were tested. So the number of results analyzed is 240.
| ID | Title | Description |
|---|---|---|
| BG000 | Arterial Blood Results | Samples collected and tested in duplicate by BGMS and compared to laboratory results |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | arterial samples | Posted | Count of Units | blood samples | 1 day | blood samples | blood samples |
|
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arterial Blood Results | Samples collected and tested in duplicate by BGMS and compared to laboratory results |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jane Wallace | Ascensia Diabetes Care | 5748501467 | jane.wallace@ascensia.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 9, 2022 | Oct 9, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| blood samples |
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| years |
| Participants |
|
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| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
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| Region of Enrollment | Number | participants | Participants |
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| Participants |
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| blood samples |
|
|
| Primary | 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). | Arterial samples tested. | Posted | Count of Units | blood samples | 1 day | blood samples | blood samples |
|
|
|
| 0 |
| 120 |
| 0 |
| 120 |
| 0 |
| 120 |
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