Postmarket Surveillance of Blood Glucose Monitor Systems Is Needed for Safety of Subjects and Accurate Determination of Effectiveness in Clinical Trials of Diabetes Drugs and Devices

Klonoff, David C.

doi:10.1177/1932296819843398

Cited by 7 publications

(11 citation statements)

References 12 publications

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“… 19 Such an approach is supported by independent commentary on the necessity for PMS for BGM devices. 20 …”

Section: Discussionmentioning

confidence: 99%

“…It should therefore be incumbent on manufacturers to provide their patients with assurances that products are effective outside of a controlled in vitro laboratory environment, using blood 19 Such an approach is supported by independent commentary on the necessity for PMS for BGM devices. 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.…”

Section: Evaluation Of Clinical Accuracy By Surveillance Error Grid (Seg)mentioning

confidence: 99%

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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

Phillips

Setford

Grady

et al. 2021

J Diabetes Sci Technol

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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.

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“… 19 Such an approach is supported by independent commentary on the necessity for PMS for BGM devices. 20 …”

Section: Discussionmentioning

confidence: 99%

Section: Evaluation Of Clinical Accuracy By Surveillance Error Grid (Seg)mentioning

confidence: 99%

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

Phillips

Setford

Grady

et al. 2021

J Diabetes Sci Technol

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“… 21 , 22 CGM-users are also encouraged to compare values to BGMs in situations where CGM values do not match symptoms. 23 Klonoff 24 has recently commented on a case where a multi-centre drug study required protocol revision due to safety concerns regarding the accuracy of an FDA-cleared BGM and has called for PMS of devices for the safety of subjects and accurate determination of the effectiveness of diabetes drugs and devices. Others also argue that current standards of BGM and indeed CGM performance are inadequate, proposing monitoring the performance of devices in the field.…”

Section: Discussionmentioning

confidence: 99%

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

Setford

Liu

McColl

et al. 2021

J Diabetes Sci Technol

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Background: On-going manufacturer-led post-market surveillance (PMS), assessing the clinical accuracy of blood glucose monitoring (BGM) systems, is critical to substantiate the performance of such products for people with diabetes. Materials and Methods: Batches of Verio test-strip product were randomly and routinely selected over the period from launch of an improved-algorithm product to reporting date and sent to 3 clinic sites for clinician-led accuracy assessment. Accuracy is reported as per recently adopted FDA guidance for BGM systems, EN ISO 15197:2015 and MARD/MAD (Mean absolute relative difference/Mean absolute difference). Results: Thirty-three individual test-strip batches were evaluated corresponding to 506 unique donors. Accuracy performance - FDA: 98.9% of values within ±15% of comparator; ISO: 99.0% within ±15 mg/dL or ±15% at <100 mg/dL (<5.55 mmol/L) or ≥100 mg/dL (≥5.55 mmol/L) glucose, respectively. Overall MARD was 4.19% with a MARD range of 3.54%-5.73% across all test strip batches. Conclusions: 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.

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“…As already mentioned, the investigators must be commended for recognising the poor performance of the glucose meter initially used in the trial. The importance of careful surveillance of blood glucose monitoring systems for safe and reliable estimates of glucose control in clinical trials has been recently emphasised [22]. However, if this is critical in a trial, unreliable glucose monitoring systems become a matter of major concern in the real-world clinical setting.…”

Section: Final Reflections On the Conclude Trialmentioning

confidence: 99%

How conclusive is the CONCLUDE trial?

Prato

2020

Diabetologia

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The development of basal insulin analogues has reduced the risk of hypoglycaemia in insulin-treated individuals with type 2 diabetes. Insulin degludec and insulin glargine 300 U/ml (glargine U300) represent an evolution of basal insulin analogues, both of them reducing the risk of hypoglycaemia as compared with that associated with glargine U100. However, whether degludec and glargine U300 are equivalent with respect to glycaemic control and risk of hypoglycaemia remains to be fully ascertained. In the CONCLUDE trial, 1609 individuals with type 2 diabetes were randomised to either degludec 200 U/ml (degludec U200) or glargine U300. In this issue of Diabetologia (

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Postmarket Surveillance of Blood Glucose Monitor Systems Is Needed for Safety of Subjects and Accurate Determination of Effectiveness in Clinical Trials of Diabetes Drugs and Devices

Cited by 7 publications

References 12 publications

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

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

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

How conclusive is the CONCLUDE trial?

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