Clinical Accuracy of a Glucose Oxidase–Based Blood Glucose Test-Strip Across Extremes of Oxygen Partial Pressure
Authors' conclusion
Data from this large-scale clinical study, performed on unmanipulated fingertip capillary bloods from a diverse diabetes population, indicate Po2 sensitivity of the BGM to be markedly lower than published studies, which are mainly laboratory-based, requiring artificial manipulation of oxygen levels in aliquots of venous blood.
Study context
- Population
- Diabetes population tested with a commercially available glucose oxidase-based BGM test-strip5,428 blood samples
- Participants
- 975 participants
- Outcome
- BGM bias by Po2 (linear regression)
Methodological detailspost-market surveillance data, post-market surveillance program, unmanipulated capillary fingertip blood samples
- Post-market surveillance data
- Post-market surveillance program
- Unmanipulated capillary fingertip blood samples
Performance
As reported in the abstract
Bias range across pressure of oxygen (Po2) (low Po2 45 mm Hg to high Po2 105 mm Hg)
5.22%
+0.72% to −4.5%
Bias at low Po2, below nominal Po2 of 75 mm Hg
+3.14%
Regression slope above nominal Po2 (>75 mm Hg); negligible impact on bias
+0.002%
Further findings
Bias under corner conditions of low (<70 mg/dL) and high (>180 mg/dL) glucose with low and high Po2
- Linear regression bias range
- +1.52% to −5.32%
- Small group of subjects
- No readings at <70 mg/dL glucose at low and high Po2
Original publication
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