Evidence From a Long-Term, Systematic Post-Market Surveillance Program: Clinical Performance of a Hematocrit-Insensitive Blood Glucose Test Strip

Abstract

Background: 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. Methods: 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. Results: 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 <5th (21.0-33.8%) and >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. Conclusions: 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.

Post-Market Surveillance Assessment of the Clinical Accuracy of a Blood Glucose Monitoring System with an Improved Algorithm for Enhanced Product Performance

“…The distribution of clinic BG values, determined by comparator ( Table 1 ) have a similar distribution to those seen in the manufacturer’s previous clinic PMS datasets. 5 - 8 …”

“…The distribution of clinic BG values, determined by comparator (Table 1) have a similar distribution to those seen in the manufacturer's previous clinic PMS datasets. [5][6][7][8] Accuracy was assessed as per FDA and ISO 15197 accuracy definitions (Table 2), although it is to be appreciated that the methodology followed differed from current FDA and ISO 15197 accuracy assessment methodologies that require the user to perform the test. ISO 15197 has a further accuracy assessment termed "system accuracy," which permits a health care professional to perform the test but requires glucose values to be proportionally distributed within prescribed glucose ranges.…”

“…LifeScan, as legal manufacturer of BGM systems routinely conducts such PMS. [5][6][7][8] Reported here is the accumulated surveillance data, since launch, of the U.S. version of the Verio Reflect BGM system, which incorporates a next-generation algorithm delivering improved clinical accuracy.…”

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

“…20 A systematic, longitudinal PMS program based on randomly selected batches and representing the full variation of both production processes and manufacturing materials has previously been demonstrated to be an effective means to assess product performance. 21 When a glucose monitoring system PMS program engages with healthcare providers (such as the NHS in the UK), additional patient prescription data should be available to assess performance against new criteria, such as polypharmacy burden. There is reason to be optimistic that improved data collection infrastructure will allow better synchronization with patient health records and thus create more widely adopted and transparent BGM and CGM surveillance activities, with consistently robust assessments of the impact of polypharmacy.…”

Distribution of Oxygen Partial Pressures in Native Capillary Fingertip Blood Samples From a Large Diabetes Patient Population

“…Data originates from samples analyzed during routine studies at four UK clinical sites as part of an ongoing postmarket surveillance program by a manufacturer to assess clinical accuracy of its portfolio of blood glucose monitoring (BGM) devices. [4][5][6][7]…”