Multicenter Evaluation of a New Strip-Based Blood Glucose System for Point-of-Care Testing in Critical and Non-Critical Care Settings
Authors' conclusion
BGMSA was effective for determining blood glucose in venous, arterial, neonatal arterial, neonatal heel stick, and capillary WB samples.
Study context
- Population
- Patients in non-critical and critical care settings; arterial, capillary, venous or heel stick whole blood (WB) samples; 14 US and three European sites2,678 samples
- Participants
- 1,577 patients
- Comparison
- Cobas Pulse vs Nova StatStrip, against hexokinase comparator
- Outcome
- Blood glucose measurement accuracy by FDA guidance criteria
Methodological detailsmulticenter
- Multicenter
Performance
As reported in the abstract
Accuracy vs FDA guidance criteria (first study)
- All accuracy criteria were met for arterial and venous samples considering all data combined
- BGMSA showed better accuracy than BGMSB for arterial, venous and heel stick, and similar results to BGMSB for capillary WB vs venous comparator
Further findings
Endogenous interference (pO2, hematocrit, sodium)
- No endogenous interference from pO2, hematocrit, and sodium was identified
Contrived samples over wide glucose range, alone and with extreme hematocrit
- BGMSA was also accurate
Second study: capillary fingerstick samples, one US site
- All accuracy criteria were met (117 samples, BGMSA vs comparator)
Safety
Clinical risk by Diabetes Technology Society Error Grids
- No clinically significant medical risks were observed
Original publication
Multicenter Evaluation of a New Strip-Based Blood Glucose System for Point-of-Care Testing in Critical and Non-Critical Care Settings. J Diabetes Sci Technol. Published 31 May 2025. doi:10.
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