867-P: Ongoing Manufacturer-Led Clinical Surveillance of Two Blood Glucose Monitoring Test Strip Systems

Diabetes ◽  
2020 ◽  
Vol 69 (Supplement 1) ◽  
pp. 867-P
Author(s):  
STEVEN J. SETFORD ◽  
LAURENCE B. KATZ ◽  
MIKE GRADY ◽  
KIRSTY MACLEOD ◽  
HILARY CAMERON
Keyword(s):  
Blood Glucose ◽  
Glucose Monitoring ◽  
Test Strip ◽  
Blood Glucose Monitoring ◽  
Monitoring Test ◽  
Clinical Surveillance

Performance of a New Test Strip for FreeStyle Blood Glucose Monitoring Systems

2011 ◽  
Vol 13 (1) ◽  
pp. 1-10 ◽  
Author(s):  
John Paul Lock ◽  
Ronald Brazg ◽  
Robert M. Bernstein ◽  
Elizabeth Taylor ◽  
Mona Patel ◽  
...  
Keyword(s):  
Blood Glucose ◽  
Glucose Monitoring ◽  
Test Strip ◽  
Blood Glucose Monitoring ◽  
Monitoring Systems

scholarly journals Evaluation of Analytical Performance of Three Blood Glucose Monitoring Systems: System Accuracy, Measurement Repeatability, and Intermediate Measurement Precision

2018 ◽  
Vol 13 (1) ◽  
pp. 111-117 ◽  
Author(s):  
Stefan Pleus ◽  
Nina Jendrike ◽  
Annette Baumstark ◽  
Jochen Mende ◽  
Cornelia Haug ◽  
...  
Keyword(s):  
Blood Glucose ◽  
Glucose Monitoring ◽  
Test Strip ◽  
Measurement Precision ◽  
Blood Glucose Monitoring ◽  
Monitoring Systems ◽  
Analytical Quality ◽  
Acceptance Criteria ◽  
Accuracy Measurement ◽  
Measurement Repeatability

Introduction: Blood glucose monitoring systems (BGMS) should provide sufficient analytical quality to allow adequate therapy for diabetes patients. Besides system accuracy, measurement precision is an important aspect of a BGMS’ analytical quality. Methods: Based on ISO 15197:2013/EN ISO 15197:2015, system accuracy, measurement repeatability, and intermediate measurement precision were assessed. ISO 15197:2013 system accuracy criteria require that ⩾95% of individual BGMS’ test strip lot results shall fall within ±15 mg/dl or ±15% of corresponding comparison method results (at glucose concentrations <100 mg/dl and ⩾100 mg/dl, respectively), and that ⩾99% of results fall within consensus error grid (CEG) zones A and B. Measurement repeatability was assessed using venous blood samples, whereas intermediate measurement precision was assessed using control solution samples. Standard deviation (SD) and coefficient of variation (CV) were calculated for glucose concentrations <100 mg/dl and ⩾100 mg/dl, respectively. Precision acceptance criteria are not specified by ISO 15197:2013. Results: All three BGMS fulfilled system accuracy criteria with 96% to 98% of individual test strip lot’s results falling within the acceptable accuracy limits. All measurement results fell within CEG zones A and B. For measurement repeatability, SD was ⩽3.3 mg/dl, and CV was ⩽3.9% for the investigated BGMS. Assessment of intermediate measurement precision showed SD ⩽1.3 mg/dl and CV ⩽3.0%. Conclusion: All three BGMS fulfilled system accuracy criteria of ISO 15197:2013. In absence of acceptance criteria, precision results were found to be consistent with the manufacturer’s labeling of the investigated devices.

Assessment of a New Visual Test Strip for Blood Glucose Monitoring

Diabetes Care ◽  
1983 ◽  
Vol 6 (6) ◽  
pp. 543-547 ◽  
Author(s):  
S. M. Marshall ◽  
K. G. M. M. Alberti
Keyword(s):  
Blood Glucose ◽  
Glucose Monitoring ◽  
Test Strip ◽  
Blood Glucose Monitoring ◽  
Visual Test

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

2021 ◽  
pp. 193229682110394 ◽  
Author(s):  
Steven Setford ◽  
Zuifang Liu ◽  
David McColl ◽  
Stuart Phillips ◽  
Hilary Cameron ◽  
...  
Keyword(s):  
Blood Glucose ◽  
Glucose Monitoring ◽  
Test Strip ◽  
Blood Glucose Monitoring ◽  
Absolute Difference ◽  
Market Surveillance ◽  
Post Market Surveillance ◽  
Post Market ◽  
Clinical Accuracy ◽  
Improved Algorithm

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.

Clinical evaluation of a novel test strip technology for blood glucose monitoring: Accuracy at hypoglycaemic glucose levels

2012 ◽  
Vol 98 (3) ◽  
pp. 430-435 ◽  
Author(s):  
Srikanth Bellary ◽  
Hillary Cameron ◽  
Kirsty Macleod ◽  
Michael Malecha ◽  
Krisna Koria ◽  
...  
Keyword(s):  
Blood Glucose ◽  
Clinical Evaluation ◽  
Glucose Monitoring ◽  
Test Strip ◽  
Blood Glucose Monitoring ◽  
Glucose Levels ◽  
Monitoring Accuracy

scholarly journals Accuracy and User Performance Evaluation of a New, Wireless-enabled Blood Glucose Monitoring System That Links to a Smart Mobile Device

2017 ◽  
Vol 11 (4) ◽  
pp. 736-743 ◽  
Author(s):  
Timothy S. Bailey ◽  
Jane F. Wallace ◽  
Scott Pardo ◽  
Mary Ellen Warchal-Windham ◽  
Bern Harrison ◽  
...  
Keyword(s):  
Blood Glucose ◽  
Monitoring System ◽  
Mobile Device ◽  
Glucose Monitoring ◽  
Test Strip ◽  
Blood Glucose Monitoring ◽  
Section 8 ◽  
Self Testing ◽  
Study Staff ◽  
Smart Mobile

Background: The new Contour®Plus ONE blood glucose monitoring system (BGMS) features an easy-to-use, wireless-enabled blood glucose meter that links to a smart mobile device via Bluetooth® connectivity and can sync with the Contour™ Diabetes app on a smartphone or tablet. Methods: The accuracy of the new BGMS was assessed in 2 studies according to ISO 15197:2013 criteria. In Study 1 (laboratory study), fingertip capillary blood samples from 100 subjects were tested in duplicate using 3 test strip lots. In Study 2 (clinical study), 134 subjects with type 1 or type 2 diabetes enrolled at 2 clinical sites. BGMS results and YSI analyzer (YSI) reference results were compared for fingertip blood obtained by untrained subjects’ self-testing and for study staff–obtained fingertip, subject palm, and venous results. Results: In Study 1, 99.0% (594/600) of combined results for all 3 test strip lots fulfilled ISO 15197:2013 Section 6.3 accuracy criteria. In Study 2, 99.2% (133/134) of subject-obtained capillary fingertip results, 99.2% (133/134) of study staff–obtained fingertip results, 99.2% (125/126) of subject-obtained palm results, and 100% (132/132) of study staff–obtained venous results met ISO 15197:2013 Section 8 accuracy criteria. Moreover, 95.5% (128/134) of subject-obtained fingertip self-test results were within ±10 mg/dl (±0.6 mmol/L) or ±10% of the YSI reference result. Questionnaire results showed that most subjects found the BGMS easy to use. Conclusions: The BGMS exceeded ISO 15197:2013 accuracy criteria both in the laboratory and in a clinical setting when used by untrained subjects with diabetes.

scholarly journals PMD79 A Population-Based Study on the Use of Blood Glucose Monitoring Test Strips

2012 ◽  
Vol 15 (7) ◽  
pp. A359
Author(s):  
J.P. Gregoire ◽  
M.C. Breton ◽  
L. Sauriol ◽  
J. Moisan
Keyword(s):  
Blood Glucose ◽  
Glucose Monitoring ◽  
Population Based ◽  
Blood Glucose Monitoring ◽  
Population Based Study ◽  
Test Strips ◽  
Monitoring Test

Mean Absolute Relative Difference of Blood Glucose Monitoring Systems and Relationship to ISO 15197

2021 ◽  
pp. 193229682110014
Author(s):  
Guido Freckmann ◽  
Jochen Mende ◽  
Stefan Pleus ◽  
Delia Waldenmaier ◽  
Annette Baumstark ◽  
...  
Keyword(s):  
Blood Glucose ◽  
Evaluation Studies ◽  
Glucose Monitoring ◽  
Test Strip ◽  
Relative Difference ◽  
Blood Glucose Monitoring ◽  
Limits Of Agreement ◽  
Measurement Results ◽  
The Mean

Background: The analytical quality of a blood glucose monitoring system (BGMS) is often assessed according to the requirements described in the international standard ISO 15197. However, the mean absolute relative difference (MARD) is sometimes used as well. This analysis aims at providing empirical data from BGMS evaluation studies conducted according to ISO 15197 and at providing an estimation of how MARD and percentage of measurement results within ISO accuracy limits are related. Methods: Results of 77 system accuracy evaluations conducted according to ISO 15197 were used to calculate MARD between BGMS and a laboratory comparison method’s results (glucose oxidase or hexokinase method). Additionally, bias and 95%-limits of agreement (LoA) using the Bland and Altman method were calculated. Results: MARD results ranged from 2.3% to 20.5%. The lowest MARD of a test strip lot that showed <95% of results within ISO limits was 6.1%. The distribution of MARD results shows that only 3.6% of test strip lots with a MARD equal to or below 7% showed <95% of results within ISO limits (2.2% of all test strip lots). Bias of test strip lots that showed ≥95% of results within the limits ranged from −10.3% to +7.4%. The half-width of the 95%-LoA of test strip lots that showed ≥95% of results within the limits ranged from 4.8% to 24.0%. Conclusion: There is a threshold MARD that may allow an estimate whether ISO 15197 requirements are fulfilled, but this statement cannot be made with certainty.

scholarly journals MON-181 Evaluation of the GLUCOCARD Shine Connex Bluetooth Enabled Blood Glucose Monitoring System's Ease of Use

2019 ◽  
Vol 3 (Supplement_1) ◽  
Author(s):  
Julie Walker ◽  
Taylor Thompson ◽  
Patricia Gill ◽  
Raji Shankar
Keyword(s):  
Blood Glucose ◽  
Glucose Monitoring ◽  
Test Strip ◽  
Ease Of Use ◽  
Blood Glucose Monitoring ◽  
Self Management ◽  
Blood Glucose Test ◽  
Consumer Study ◽  
Glucose Test ◽  
Self Test

Abstract Background: It is important that a Blood Glucose Monitoring System (BGMS) is easy to use since it is a critical tool used in the self-management of diabetes, including the prevention of micro and macrovascular complications. The “Ease of Use” consumer study is typically evaluated as part of the FDA 510(k) approval process for BGMS. Purpose: The objective of this study was to further verify the Ease of Use of the GLUCOCARD Shine Connex Bluetooth Enabled BGMS. Methods: A total of 20 subjects with confirmed diabetes between the ages of 40 to 89 participated in the IRB-approved study at ARKRAY in Minneapolis, MN during October 2018. 80.0% of the subjects fell between the ages of 60 to 89 years of age. The subjects were asked to perform a fingerstick self-test and answer a questionnaire directed at the Ease of Use of the device and test strip. All the subjects responded to the topics in the questionnaire which included, “Removing a Test Strip from Bottle”, “Inserting a Test Strip into the Meter”, “Removing a Test Strip from the Meter”, “Performing a Blood Glucose Test from your Fingertip” and “Reading Meter Display”. The subjects were asked to rate the topics as Very Easy, Easy, OK, Difficult, or Very Difficult. For evaluation purposes, these topics were grouped as Positive [Very Easy/Easy/OK] and Negative [Difficult/Very Difficult]. Results: From the questionnaire, “Removing a Test Strip from Bottle” and “Inserting a Test Strip into the Meter” received a 95.0% positive rating while all the remaining topics received a 100.0% positive rating, including “Removing a Test Strip from the Meter”, “Performing a Blood Glucose Test from your Fingertip” and “Reading Meter Display”. Conclusion: The GLUCOCARD Shine Connex Bluetooth Enabled BGMS scored a 98.0% positive overall average Ease of Use rating by the subjects.

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