Clinical Performance of the TRUE2go Blood Glucose Monitoring System Exceeds Minimum Criteria for Accuracy Using ISO 15197:2013

Transcription

1 linical Performance of the TRUE2go lood Glucose Monitoring System Exceeds Minimum riteria for Accuracy Using ISO 197:213

2 LINIAL STUY SUMMARY EVALUATION OJETIVES This clinical evaluation: 1. Evaluates the accuracy of the TRUE2go System utilizing international standard ISO 197: ompares the performance of the TRUE2go lood Glucose Monitoring System utilizing ISO 197:213 accuracy criteria to the performance of the TRUE2go System utilizing the EN ISO 197:23 international standard. 3. Proves that lay users of the TRUE2go lood Glucose Monitoring System can obtain accurate results consistent with those obtained by trained professionals. 4. Proves that the TRUE2go lood Glucose Monitoring System is easy to use by first-time users. 5. Proves that the TRUE2go lood Glucose Monitoring System produces precise results when measuring duplicate fingerstick samples. ISO STANAR 197:23 1 OMPARE TO ISO 197:213 2 An ISO Standard is developed in response to an identified need in the community, and that will eventually be suitable for implementation on as broad a basis as possible. ISO developed the standard for blood glucose monitoring performance based on a consensus of professionals around the world. A clinical accuracy study was conducted according to the methodology requirements of ISO 197:213. The data were assessed and compared using the accuracy bias limits of both EN ISO 197:23 and ISO 197:213. elow is a table outlining the accuracy parameters we evaluate in this study. Accuracy Parameter EN ISO 197:23 ISO 197:213 Target blood glucose level from which to base mg/dl bias or % bias 75 mg/dl 1 mg/dl Acceptable bias from reference value for lower target glucose levels Acceptable bias from reference value for higher target glucose levels Acceptable % of all results within bias limits Parkes Error Grid Not required +/- mg/dl +/- mg/dl +/- 2% +/- % 95% 95% 99% of results within Zones A and 1

3 LINIAL STUY SUMMARY The graph to the right illustrates the comparison of the EN ISO 197:23 bias limits compared to ISO 197:213 criteria for accuracy. ias from YSI (mg/dl) lood Glucose Results EN ISO 197:23 ISO 197:213 SITES AN SUJETS linical evaluations of the TRUE2go System were conducted at 2 clinical institutions across the U.S. In total, 191 subjects completed the protocol across the 2 evaluation sites. Study demographics shown below. Ethnicity ategory White African American Hispanic American Indian Asian Other Not Recorded User Study 27% 72% 1% % % % % Accuracy Study 3% 56% 4% 2% 6% 2% % Gender ategory Male Female Not Recorded User Study 46% 54% % Accuracy Study 41% 57% 2% Age (Years) ategory Average Maximum Minimum User Study Accuracy Study Years of Education ategory <12 12 >12 Not Recorded User Study 7% 56% 37% % Accuracy Study 1% 39% 39% 12% LINIAL EVALUATION METHOS linical Evaluations performed using the TRUE2go lood Glucose Monitoring System: 1. Accuracy of fingerstick results obtained by patients and healthcare professionals (HP) compared to the laboratory reference (three test strip lots used). 2. Accuracy of fingerstick results obtained by healthcare professionals compared to the laboratory reference using Parkes Error Grid analysis (three test strip lots used). 3. User performance evaluation including healthcare professional feedback on first-time user testing technique (one test strip lot used). 2

4 TRUE2go HP Finger ISO 197:213 TRUE2go HP Finger ISO 197:2 8 1 TRUE2go ias from YSI (mmol/l) TRUE2go ias fromysi (mg/dl) TOPLINE RESULTS USING ISO RITERIA In this study using fingerstick samples obtained by healthcare professionals, the TRUE2go System -1 produced 1% of results within the bias limits for EN ISO 197:23 and 99.3% within -4 the bias limits for ISO 197: TRUE2go ias fromysi (mg/dl) YSI Plasma Result (mmol) TRUE2go HP Finger ISO 197:23 TRUE2go HP Finger ISO 197: TRUE2go HP Finger ISO 197:23 TRUE2go ias from YSI (mg/dl) 1 TRUE2go ias from YSI (mmol/l) YSI Plasma Result (mmol/l) ISO 197:213 requires 3 lots of test strips to be used in the evaluation TRUE2go HP Finger ISO 197:23 TRUE2go ias from YSI (mg/dl) Summary of TRUE2go System accuracy against the YSI reference method using 1 EN ISO 197:23 and ISO 197:213. EN ISO 197:23 Samples < 75 mg/dl ± 5 mg/dl ± 1 mg/dl ± mg/dl 52/74 7.1% 74/74 1.% 74/74 1.% 5 ISO 197:213 Samples < 1 mg/dl -5 ±-1 5 mg/dl ± 1 mg/dl ± mg/dl 12/18 172/18 18/ % Samples 75 mg/dl % 1.% Samples 1 mg/dl ± 5% ± 1% ± % ± 2% ± 5% ± 1% ± % 274/ /526 52/ / % 85.7% 98.9% 1.% 223/ % 364/ % 416/42 99.% 3 5 6

5 TOPLINE RESULTS USING ISO RITERIA In this study, first-time users of the TRUE2go System obtained accurate results compared to the laboratory reference method. TRUE2go ias from YSI (mg/dl) of 1 within limits = 99% TRUE2go User Finger ISO 197: ISO 197:213 requires 1 data points from user self-testing Samples < 1 mg/dl ± 5 mg/dl ± 1 mg/dl ± mg/dl 23/26 25/26 26/ % 96.2% 1.% Samples 1 mg/dl ± 5 % ± 1 % ± % 42/74 68/74 73/ % 91.9% 98.6% TRUE2go System Accuracy Results for total glucose concentrations. Within +/- mg/dl and within +/-% 99/1 (99%) 4

6 TOPLINE RESULTS USING PARKES ERROR GRI PARKES ERROR GRI3 Parkes et al. developed an error grid to analyze the clinical significance of the bias between blood glucose system results and lab reference results. For analysis, data points are assigned into one of the five Zones (A-E) on the error grid. Results, or data points, falling into Zones A and are defined as clinically acceptable, where any observed bias from lab results would not lead to treatment decisions that may put a patient at risk. As the bias, or difference, increases (Zones,, and E), there is greater risk of undertreating or overtreating a patient based on the glucose system result. Analysis of data using the Parkes Error Grid is a requirement in ISO 197:213. The TRUE2go System, in the hands of healthcare professionals, is proven to provide accurate fingerstick results that are comparable to the YSI reference method. TRUE2go HP Finger vs Y TRUE2go HP Finger vs. YSI E A A 5 Zone 3 y = 1.2x R = # Points2 A 6 E Total % 1% % % 1 % % % Results In Zone % 5 1 YSI Plasma Result TRUE2go User Finger vs YSI 5 TRUE2go User Finger v 3 A eter Result (mg/dl) 3 5 y =.98x Meter Result (mmol/l) E 3 ZONE OUNT Meter Result (mmol/l) TRUE2go HP Finger Result (mg/dl) E

7 TOPLINE RESULTS USING M.A.R.E. 4 The TRUE2go System, in the hands of healthcare professionals, is proven to provide precise results that are comparable to the laboratory reference method. M.A.R.E. (or Mean Absolute Relative Error) is a statistical calculation that measures how close, on average, meter results compare to the laboratory reference method. M.A.R.E. is calculated by taking the average for the set of individual absolute errors relative to its reference value. Meter results are more accurate and precise with a lower M.A.R.E. value. TRUE2go M.A.R.E. Value 5.6% M.A.R.E. = n i=1 m ( i - y i ) y i X 1 Where m i is the meter result, y i is the reference value, and n is the number of data points in the population. The number is calculated by summing up the absolute value of the percent bias between all meter results and the reference values. This sum is then divided by the total number of data points in the population. n First-time users of the TRUE2go System agreed that the system was easy to use and achieved accurate and precise results. Healthcare professionals positively ranked first-time users compliance with the instructions for using the TRUE2go System. Was the system easy to use? Was the display easy to read? Were instructions clear on how to read results? id instructions adequately describe how to apply blood? Were instructions easy to understand? User Evaluation id patient follow the written instructions? id patient read result correctly? id patient apply blood correctly? id patient insert strip correctly? HP Evaluation

8 ONLUSION In this study, the TRUE2go System demonstrated accurate performance in the hands of both healthcare professionals and first-time users. linical data obtained by both first-time users and healthcare professionals exceeded the minimum accuracy criteria for EN ISO 197:23 and the more rigorous minimum accuracy criteria for ISO 197:213. First-time users of the TRUE2go System agreed that the instructions were easy to understand and the system was easy to use. The TRUE2go System produced precise results as evidenced by a mean absolute relative error value of 5.6%. 1. International Organization for Standardization. In vitro diagnostic test systems. Requirements for blood glucose monitoring system for self testing in managing diabetes mellitus. Reference number EN ISO 197:23 (E). Geneva: International Organization for Standardization; International Organization for Standardization. In vitro diagnostic test systems. Requirements for blood glucose monitoring system for self testing in managing diabetes mellitus. Reference number ISO 197:213. Geneva: International Organization for Standardization; Parkes JL, Slatin SL, Pardo S, Ginsberg H. A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose. iabetes are, 2; 23(8): Ginsberg, arry H., M.., Ph.. Factors affecting blood glucose monitoring: sources of errors in measurement. Journal of iabetes Science and Technology, Volume 3, Issue 4, July 29: pp FOR AITIONAL INFORMATION OR QUESTIONS, ARESS WRITTEN REQUESTS TO: Nipro iagnostics, Inc. 24 NW 55th t. Ft. Lauderdale, FL Nipro iagnostics, Inc. TRUE2go and the Nipro iagnostics logo are trademarks of Nipro iagnostics, Inc. MKT52 Rev. 22