Gestational diabetes & diabetes in pregnancy
Evaluation of the analytical and clinical accuracy of four blood glucose meters in pregnant women with hyperglycaemia
Authors' conclusion
Accuracy of meters was higher when using venous samples than when using capillary samples. Contour Next and Accu-Chek Guide meters met accuracy standards in all analyses.
Study context
- Population
- Consecutive pregnant women with diabetes in pregnancy (hyperglycaemia); GDM 57%824 paired samples analysed
- Participants
- 103 women
- Comparison
- Four blood glucose meters vs i-STAT (amperometry) and laboratory (hexokinase) glucose as reference methods
- Outcome
- Mean bias [95% limits of agreement]
Methodological detailsconsecutive women, capillary and venous samples collected concurrently
- Consecutive women
- Capillary and venous samples collected concurrently
Performance
As reported in the abstract
| Test or model | Mean bias vs i-STAT | Mean bias vs laboratory |
|---|---|---|
| Contour Next | 1.3% [−8% to 10.6%] | −0.2% [−8.1% to 7.7%] |
| Accu-Chek Guide | −3.2% [−11.4% to 5%] | −0.2% [−10.2% to 9.8%] |
| FreeStyle Optium Neo | −11.9% [−24.7% to 0.8%] | −3.8% [−17.6% to 10%] |
| LifeSmart | 6.8% [−5.8% to 19.4%] | 6.1% [−5.9% to 18.2%] |
Mean bias vs i-STAT
Contour Next1.3% [−8% to 10.6%]
Accu-Chek Guide−3.2% [−11.4% to 5%]
FreeStyle Optium Neo−11.9% [−24.7% to 0.8%]
LifeSmart6.8% [−5.8% to 19.4%]
Mean bias vs laboratory
Contour Next−0.2% [−8.1% to 7.7%]
Accu-Chek Guide−0.2% [−10.2% to 9.8%]
FreeStyle Optium Neo−3.8% [−17.6% to 10%]
LifeSmart6.1% [−5.9% to 18.2%]
- Mean capillary glucose on all meters significantly different from i-STAT
- all p < 0.001
Further findings
Pairs within surveillance error grid (SEG) no-risk zone
- Only Contour Next and Accu-Chek Guide had ≥97% of pairs within the SEG no-risk zone during both comparisons
Haematocrit influence
- Median haematocrit
- 0.36 L/L
- Meters did not show haematocrit-related bias
Original publication
Evaluation of the analytical and clinical accuracy of four blood glucose meters in pregnant women with hyperglycaemia. Diabetes Obes Metab. Published 24 January 2025. doi:10.
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