Anja Schuster, C. Roth, L. Stechemesser, R. Weitgasser, Karin Schwenoha Gertie Janneke Oostingh
{"title":"从<s:1>现实生活<e:1>角度看体外诊断法规实施的挑战血糖自我监测装置的性能","authors":"Anja Schuster, C. Roth, L. Stechemesser, R. Weitgasser, Karin Schwenoha Gertie Janneke Oostingh","doi":"10.37532/1758-1907.2021.11(7).257-264","DOIUrl":null,"url":null,"abstract":"Objective: Accurate and reliable blood glucose monitoring devices (BGMDs) are required for adequate self-monitoring and management for people suffering from diabetes mellitus. To ensure a high level of safety for patients and users of in vitro diagnostic devices, an updated In Vitro Diagnostic Regulation (IVDR 2017/746) has been published, including new safety and performance prerequisites. However, BGMD accuracy may be limited by certain ‘real-life’ environmental factors, which should be respected in the performance evaluation. Methods: The temperature-and humidity-dependent performance of 4 different BGMD using up to 440 capillary blood samples was determined. BGMDs with associated test strips were stored at 15°C, 25°C and 35°C resp. at a relative humidity of 40% and 80% in order to imitate potential ‘real-life’ performance settings. Glucose measurements were compared to blood glucose values determined using standardized Laboratory equipment and were analyzed based on the ISO 15197:2013 system accuracy criteria. Results: Two out of three BGMDs provided consistent results across temperature ranges based on the medical threshold of a mean glucose change less than 15 mg/dl, although blood glucose difference of up to 96 mg/dl was found at an individual patient level after pairwise temperature comparison. For one device up to 31.2% of patients’ values were outside the defined limits when comparing 15o C to 35o C. Changes in humidity levels did not significantly influence the mean values across the BGMDs, although high deviations were observed at patients’ individual glucose levels. Conclusion: Moderate temperature and humidity changes can affect the accuracy of point-of\u0002care devices to a profound extent at an individual patient level. These ‘real-life’ environmental factors need to be included in the performance evaluation as required in the IVDR 2017/746 in order to provide a solid testing system for novel point-of-care-devices.","PeriodicalId":89355,"journal":{"name":"Diabetes management (London, England)","volume":"11 1","pages":"257-264"},"PeriodicalIF":0.0000,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Challenges for the implementation of the in-vitro diagnostics regulations in the light of â??real-lifeâ?? performance of blood glucose self-monitoring devices\",\"authors\":\"Anja Schuster, C. Roth, L. Stechemesser, R. Weitgasser, Karin Schwenoha Gertie Janneke Oostingh\",\"doi\":\"10.37532/1758-1907.2021.11(7).257-264\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Objective: Accurate and reliable blood glucose monitoring devices (BGMDs) are required for adequate self-monitoring and management for people suffering from diabetes mellitus. To ensure a high level of safety for patients and users of in vitro diagnostic devices, an updated In Vitro Diagnostic Regulation (IVDR 2017/746) has been published, including new safety and performance prerequisites. However, BGMD accuracy may be limited by certain ‘real-life’ environmental factors, which should be respected in the performance evaluation. Methods: The temperature-and humidity-dependent performance of 4 different BGMD using up to 440 capillary blood samples was determined. BGMDs with associated test strips were stored at 15°C, 25°C and 35°C resp. at a relative humidity of 40% and 80% in order to imitate potential ‘real-life’ performance settings. Glucose measurements were compared to blood glucose values determined using standardized Laboratory equipment and were analyzed based on the ISO 15197:2013 system accuracy criteria. Results: Two out of three BGMDs provided consistent results across temperature ranges based on the medical threshold of a mean glucose change less than 15 mg/dl, although blood glucose difference of up to 96 mg/dl was found at an individual patient level after pairwise temperature comparison. For one device up to 31.2% of patients’ values were outside the defined limits when comparing 15o C to 35o C. Changes in humidity levels did not significantly influence the mean values across the BGMDs, although high deviations were observed at patients’ individual glucose levels. Conclusion: Moderate temperature and humidity changes can affect the accuracy of point-of\\u0002care devices to a profound extent at an individual patient level. These ‘real-life’ environmental factors need to be included in the performance evaluation as required in the IVDR 2017/746 in order to provide a solid testing system for novel point-of-care-devices.\",\"PeriodicalId\":89355,\"journal\":{\"name\":\"Diabetes management (London, England)\",\"volume\":\"11 1\",\"pages\":\"257-264\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2021-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Diabetes management (London, England)\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.37532/1758-1907.2021.11(7).257-264\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Diabetes management (London, England)","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.37532/1758-1907.2021.11(7).257-264","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Challenges for the implementation of the in-vitro diagnostics regulations in the light of â??real-lifeâ?? performance of blood glucose self-monitoring devices
Objective: Accurate and reliable blood glucose monitoring devices (BGMDs) are required for adequate self-monitoring and management for people suffering from diabetes mellitus. To ensure a high level of safety for patients and users of in vitro diagnostic devices, an updated In Vitro Diagnostic Regulation (IVDR 2017/746) has been published, including new safety and performance prerequisites. However, BGMD accuracy may be limited by certain ‘real-life’ environmental factors, which should be respected in the performance evaluation. Methods: The temperature-and humidity-dependent performance of 4 different BGMD using up to 440 capillary blood samples was determined. BGMDs with associated test strips were stored at 15°C, 25°C and 35°C resp. at a relative humidity of 40% and 80% in order to imitate potential ‘real-life’ performance settings. Glucose measurements were compared to blood glucose values determined using standardized Laboratory equipment and were analyzed based on the ISO 15197:2013 system accuracy criteria. Results: Two out of three BGMDs provided consistent results across temperature ranges based on the medical threshold of a mean glucose change less than 15 mg/dl, although blood glucose difference of up to 96 mg/dl was found at an individual patient level after pairwise temperature comparison. For one device up to 31.2% of patients’ values were outside the defined limits when comparing 15o C to 35o C. Changes in humidity levels did not significantly influence the mean values across the BGMDs, although high deviations were observed at patients’ individual glucose levels. Conclusion: Moderate temperature and humidity changes can affect the accuracy of point-ofcare devices to a profound extent at an individual patient level. These ‘real-life’ environmental factors need to be included in the performance evaluation as required in the IVDR 2017/746 in order to provide a solid testing system for novel point-of-care-devices.