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

Abstract

Background Regulations and industry guidance relating to testing for interference in blood glucose monitoring (BGM) systems continue to focus on in vitro laboratory bench tests. Post-market surveillance (PMS) in a clinical setting allows for BGM accuracy assessments to evaluate the impact of real-world exposure to polypharmacy in people with diabetes. This study evaluated the OneTouch Select Plus® BGM test-strip accuracy with respect to polypharmacy using a clinical registry dataset. Methods Medication profiles were analysed for 1023 subjects (425 with type 1 (T1D) and 598 with type 2 diabetes (T2D)) attending 3 UK hospitals. Blood samples were analysed to determine clinical accuracy of the BGM test-strip against a laboratory comparator. Results 538 different medications (48 diabetes and 490 non-diabetes) were recorded across the 1023 subjects. Patients took on average 6.9 ( n = 1-36) individual medications and 4.1 ( n = 1-13) unique medication classes. Clinical accuracy to EN ISO 15197:2015 criteria were met irrespective of increasing average number of individual medications, categorized from 1-3, 4-6, 7-9, 10-12 and >12 taken per subject (97.7%, 97.7%, 97.8%, 97.8%, and 98.4%, respectively). Clinical accuracy criteria were met across 15 classes of medication using the combined dataset (97.9%; 29784/30433). Surveillance Error Grid (SEG) analysis showed 98.7% (29959/30368) of readings presented no clinical risk. No individual class or combination of medication classes impacted clinical accuracy of the BGM test-strip. Conclusions 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.

Drug Interference in Self-Monitoring of Blood Glucose and the Impact on Patient Safety: We Can Only Guard Against What We Are Looking for

“…Similar methods using real-world data from post-market surveillance have been used for various systems to complement data from ISO 15197 interference studies. 21,22 People with diabetes are often multimorbid and are treated with multiple drugs. The described method can detect interferences only arising out of synergistic effects caused by polypharmacy.…”

“…Similar methods using real-world data from post-market surveillance have been used for various systems to complement data from ISO 15197 interference studies. 21 , 22 …”

Traditional Interference Experiments vs. Method Comparison Interference Experiments

“…Two recent papers have evaluated interferences in glucose meters. 1,2 These are method comparisons with the added information of the medication(s) taken by the subjects. These studies called here; method comparison interference protocols (MCIP) deviate from traditional interference studies.…”