Post-Market Surveillance Assessment of the Clinical Accuracy of a Blood Glucose Monitoring System with an Improved Algorithm for Enhanced Product Performance
Authors' conclusion
This post-market surveillance program demonstrates the new BGM system consistently meets measures of clinical accuracy specified by regulators. This program supports a growing demand by regulators for real-world evidence demonstrating consistent in-market product efficacy as opposed to the current largely passive approach that relies on assessment of reports filed by device users.
Study context
- Population
- Donors at 3 clinic sites; batches of Verio test strips from launch of improved-algorithm product to reporting date33 test-strip batches
- Participants
- 506 donors
- Outcome
- Accuracy per FDA guidance for blood glucose monitoring (BGM) systems, EN ISO 15197:2015 and MARD/MAD
Methodological detailsmanufacturer-led, 3 clinic sites, clinician-led, batches randomly and routinely selected
- Manufacturer-led
- 3 clinic sites
- Clinician-led
- Batches randomly and routinely selected
Performance
As reported in the abstract
Clinical accuracy vs comparator
FDA: values within ±15% of comparator
98.9%
ISO: within ±15 mg/dL or ±15% at <100 mg/dL (<5.55 mmol/L) or ≥100 mg/dL (≥5.55 mmol/L) glucose, respectively
99.0%
Overall MARD
4.19%
MARD range across all test strip batches
3.54%-5.73%
Original publication
Post-Market Surveillance Assessment of the Clinical Accuracy of a Blood Glucose Monitoring System with an Improved Algorithm for Enhanced Product Performance. J Diabetes Sci Technol. Published 31 August 2021. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →