Evidence From a Long-Term, Systematic Post-Market Surveillance Program: Clinical Performance of a Hematocrit-Insensitive Blood Glucose Test Strip
- 7 February 2019
- journal article
- research article
- Published by SAGE Publications in Journal of Diabetes Science and Technology
- Vol. 15 (1), 67-75
- https://doi.org/10.1177/1932296819826968
Abstract
Described is a manufacturer’s systematic post-market evaluation of the long-term clinical accuracy of a commercially available blood glucose monitoring (BGM) test strip product. Production batches of test strips were routinely and regularly sampled and evaluated in a clinical setting to assess product accuracy. Evaluations were performed on capillary blood samples from a minimum of 100 subjects with diabetes, by clinical staff according to instructions for use. Readings were compared against capillary blood samples collected at the same time and measured by a standard laboratory reference method. Clinical accuracy was calculated according to EN ISO 15197:2015. A total of 21 115 paired results were obtained, equating to 209 production batches over the >3-year period since test strip launch. Of the results, 97.6% met the accuracy criterion (range: 97.1-98.1% by year), with 98.1% of values presenting zero risk as defined by the surveillance error grid. At the 95th (48.3-59.4%) percentile extremes of hematocrit distribution, 97.9% and 96.4% of values were clinically accurate. The product also demonstrated clinical accuracy across all seven glucose ranges (“bins”) as defined by the standard. Under conditions of combined hematocrit and glucose (<80 mg/dL and ≥300 mg/dL) extremes, 97.7% of values were clinically accurate. Methodologies and results from a manufacturer’s self-imposed clinical accuracy surveillance program of a BGM product is presented. Given the publication of sometimes-conflicting data presented within ad hoc BGM clinical accuracy evaluations, usually of limited size, it is advocated that BGM manufacturers adopt similarly robust and systematic surveillance programs to safeguard patients.Keywords
Funding Information
- LifeScan Scotland Ltd
This publication has 21 references indexed in Scilit:
- Performance of Cleared Blood Glucose Monitor SystemsDiabetes, 2018
- Investigation of the Accuracy of 18 Marketed Blood Glucose MonitorsDiabetes Care, 2018
- Seven-Year Clinical Surveillance Program Demonstrates Consistent MARD Accuracy Performance of a Blood Glucose Test StripJournal of Diabetes Science and Technology, 2018
- Hypoglycemia: a review of definitions used in clinical trials evaluating antihyperglycemic drugs for diabetesClinical Epidemiology, 2017
- Seven-Year Surveillance of the Clinical Performance of a Blood Glucose Test Strip ProductJournal of Diabetes Science and Technology, 2017
- Surveillance of the System Accuracy of Two Systems for Self-Monitoring of Blood Glucose After Market ApprovalJournal of Diabetes Science and Technology, 2015
- Performance of Cleared Blood Glucose MonitorsJournal of Diabetes Science and Technology, 2015
- Accuracy Evaluation of Contour Next Compared with Five Blood Glucose Monitoring Systems Across a Wide Range of Blood Glucose Concentrations Occurring in a Clinical Research SettingDiabetes Technology & Therapeutics, 2015
- The Surveillance Error GridJournal of Diabetes Science and Technology, 2014
- Computing the Surveillance Error Grid AnalysisJournal of Diabetes Science and Technology, 2014