Diabetes Mellitus
Conditions
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.
Detailed 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.
Interventions
DEVICEDevice: 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.
Sponsors
Ascensia Diabetes Care
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Results From the Contour Next BGMSs Reference Values Within ±12.5% of Reference Values | 1 day | 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). |
| Number of Results From the Contour Plus Elite BGMSs Reference Values Within ±12.5% of Reference Values | 1 day | 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). |
Countries
Australia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arterial Blood Results Samples collected and tested in duplicate by BGMS and compared to laboratory results | 120 |
| Arterial Blood Results Samples collected and tested in duplicate by BGMS and compared to laboratory results | 240 |
| Total | 360 |
Baseline characteristics
| Characteristic | Arterial Blood Results |
|---|---|
| Age, Continuous | 59.2 years STANDARD_DEVIATION 16.1 |
| Region of Enrollment Australia | 120 participants |
| Sex: Female, Male Female | 39 Participants |
| Sex: Female, Male Male | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 120 |
| other Total, other adverse events | 0 / 120 |
| serious Total, serious adverse events | 0 / 120 |
Outcome results
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).
Time frame: 1 day
Population: arterial samples
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Arterial Blood Results | Number of Results From the Contour Next BGMSs Reference Values Within ±12.5% of Reference Values | 236 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).
Time frame: 1 day
Population: Arterial samples tested.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Arterial Blood Results | Number of Results From the Contour Plus Elite BGMSs Reference Values Within ±12.5% of Reference Values | 240 blood samples |