Post-Market Surveillance of a Blood Glucose Test Strip Demonstrates No Evidence of Interference on Clinical Accuracy in a Large Cohort of People with Type 1 or Type 2 Diabetes
Authors' conclusion
Clinical performance for the test strip under assessment demonstrated no evidence of interference from over 500 prescription medications, with clinical accuracy maintained across a range of polypharmacy conditions in people with diabetes.
Study context
- Population
- People with T1D or T2D attending 3 UK hospitals; OneTouch Select Plus blood glucose monitoring (BGM) test strip425 T1D, 598 T2D
- Participants
- 1,023 people
- Comparison
- BGM test-strip accuracy across polypharmacy categories vs laboratory comparator
- Outcome
- Clinical accuracy to EN ISO 15197:2015 criteria with respect to polypharmacy
Methodological detailsclinical registry dataset, multicentre
- Clinical registry dataset
- Multicentre
Performance
As reported in the abstract
Readings meeting EN ISO 15197:2015 clinical accuracy criteria, by number of individual medications
- Clinical accuracy criteria met across 15 medication classes (combined dataset)
- 97.9%; 29784/30433
Further findings
Surveillance Error Grid (SEG) analysis: readings with no clinical risk
- Readings presenting no clinical risk
- 98.7% (29959/30368)
Medication use
- Different medications recorded (48 diabetes, 490 non-diabetes)
- 538
- Mean individual medications per patient (n = 1-36)
- 6.9
- Mean unique medication classes per patient (n = 1-13)
- 4.1
Original publication
Post-Market Surveillance of a Blood Glucose Test Strip Demonstrates No Evidence of Interference on Clinical Accuracy in a Large Cohort of People with Type 1 or Type 2 Diabetes. J Diabetes Sci Technol. Published 4 September 2021. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →