关于血糖仪

根据国际糖尿病联合会的数据,2017年全球有4.25亿人(20-79岁)(占全球人口的9%以上)患有糖尿病,另有3.52亿人患有2型糖尿病的高风险。

据估计,每6秒钟就有1人死于糖尿病,2017年死于糖尿病的人有400万人。令人担忧的是,这一流行病没有丝毫缓和的迹象,到2045年,糖尿病患者的人数预计将达到6.29亿。

血糖仪的临床准确性

血糖仪验证开发

如下所列,独立验证血糖仪的协议由美国糖尿病协会于1987年发起。一些组织,包括FDA,加拿大标准协会和美国的临床和实验室标准协会(或国家临床实验室委员会) 众所周知的标准(在2005年之前)也制定了验证标准,其中许多均已修订。 除了2013年的CLSI标准外,其中大多数已被撤回或取代。 ISO与CEN一起在2000年制定了标准草案15197,该草案于2002年完成,并于2003年和2013年进行了修订。Klonoff等人在2015年提出了新的验证程序的最新要求。[2]

错误网格

1987年,Clarke等人首先提出了误差网格分析方法,以量化血糖仪误差水平对自我测量的潜在危害(相对于参考测量),该论文在本文中进行了描述,被称为克拉克错误网格。 [3] Parkes等。 在2000年发布了另一种共识错误网格,也称为 Parkes错误网格 [4],现在它已成为ISO 15197:2013的一部分。 Klonoff等人在2014年描述了 Surveillance Error Grid [5]。

  1. International Diabetes Federation. IDF Diabetes Atlas, 6th Edition, 2014 Update [Internet]. Brussels: IDF; 2015 [Updated 2015 Mar 07; Cited 2015 Jul 03].
  2. Klonoff DC, Lias C, Beck S, Parkes JL, Kovatchev B, Vigersky RA, Arreaza-Rubin G, Burk RD, Kowalski A, Little R, Nichols J, Petersen M, Rawlings K, Sacks DB, Sampson E, Scott S, Seley JJ, Slingerland R, Vesper HW. Development of the Diabetes Technology Society Blood Glucose Monitor System Surveillance Protocol. J Diabetes Sci Technol. 2016 May 3;10(3):697-707. doi: 10.1177/1932296815614587. Epub 2015 Oct 18. PMID: 26481642.
  3. Clarke WL, Cox D, Gonder-Frederick LA, Carter W, Pohl SL. Evaluating clinical accuracy of systems for self-monitoring of blood glucose. Diabetes Care. 1987;10(5):622–8. doi: 10.2337/diacare.10.5.622. PMID: 3677983. 在这里下载.
  4. Parkes JL, Slatin SL, Pardo S, Ginsberg BH. A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose. Diabetes Care. 2000;23(8):1143-8. doi: 10.2337/diacare.23.8.1143. PMID: 10937512. 在这里下载.
  5. Klonoff DC, Lias C, Vigersky R, Clarke W, Parkes JL, Sacks DB, Kirkman MS, Kovatchev B; Error Grid Panel. The surveillance error grid. J Diabetes Sci Technol. 2014;8(4):658-72. doi: 10.1177/1932296814539589. PMID: 25562886. 在这里下载.

血糖仪的临床验证方案

ISO/IEC/CEN/DIN
 15197:2013International Organization for Standardization Technical Committees ISO/TC 212 and ISO/TC 140. ISO 15197:2013, In vitro diagnostic test systems – Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. Geneva, Switzerland: ISO; 2013. Preview available here.
 idem quod
 Comité Européen de Normalisation CEN/TC 140. EN ISO 15197:2015, In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. Geneva, Switzerland: CEN; 2015 Jun 10.
DTS
 DTS:2016Klonoff DC, Lias C, Beck S, Parkes JL, Kovatchev B, Vigersky RA, Arreaza-Rubin G, Burk RD, Kowalski A, Little R, Nichols J, Petersen M, Rawlings K, Sacks DB, Sampson E, Scott S, Seley JJ, Slingerland R, Vesper HW. Development of the Diabetes Technology Society Blood Glucose Monitor System Surveillance Protocol. J Diabetes Sci Technol. 2016 May 3;10(3):697-707. doi: 10.1177/1932296815614587. PMID: 26481642. 在这里下载
FDA
 FDA:2016PUS Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of In Vitro Diagnostic Device Evaluation and Radiological Health, Division of Chemistry and Toxicology Devices. Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use – Guidance for Industry and Food and Drug Administration Staff. Rockville, Maryland, USA: FDA; 2016. 在这里下载
 FDA:2016HUS Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of In Vitro Diagnostic Device Evaluation and Radiological Health, Division of Chemistry and Toxicology Devices. Self-Monitoring Blood Glucose Test Systems for Over-the- Counter Use – Guidance for Industry and Food and Drug Administration Staff. Rockville, Maryland, USA: FDA; 2016. 在这里下载
CLSI
 CLSI:2013Clinical and Laboratory Standards Institute. CLSI POCT12 A3 Ed. 3 (2013), Point-of-care Blood Glucose Testing in Acute and Chronic Care Facilities. Wayne, Pennsylvania, USA: CLSI; 2013.
 CLSI:2008Klonoff D, Bernhardt P, Ginsberg BH, Joseph J, Mastrototaro J, Parker DR, Vesper H, Vigersky R. CLSI POCT05-A Ed. 1 (2008), POCT05-A: Performance Metrics for Continuous Interstitial Glucose Monitoring; Approved Guideline. Wayne, Pennsylvania, USA: CLSI; 2008. 这里的信息
Chinese Medical Association
 CMA:2016中华医学会检验医学分会 [Chinese Medical Association, Laboratory Medicine Branch]. 便携式血糖仪临床操作和质量管理规范 中国专家共识 [Portable blood glucose meter clinical operation and quality management practices – Chinese expert consensus]. 中华医学杂志 [Natl Med J China] 2016 Sep 27;96(36):2864–7. 在这里下载

ISO/IEC/CEN/DIN
 15197:2011Межгосударственный совет по стандартизации, метрологии и сертификации. ГОСТ ISO 15197-2011, Системы диагностические in vitro. Требования к системам мониторного наблюдения за концентрацией глюкозы в крови для самоконтроля при лечении сахарного диабета. Москва, Россия: МГС; 2013. [EuroAsian Interstate Council for Standardization, Metrology and Certification GOST ISO 15197-2011, In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. Moscow, Russia: EASC; 2013.] 这里的信息
 15197:2003International Organization for Standardization Technical Committee ISO/TC 212. EN ISO 15197:2003, In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. Geneva, Switzerland: ISO; 2003. 这里的信息
 15197:2002International Organization for Standardization. DIN EN ISO 15197:2002, Determination of performance criteria for in vitro blood glucose monitoring systems for management of human diabetes mellitus. ISO 15197. Geneva, Switzerland: ISO; 2002.
 15197:2001International Organization for Standardization. ISO Draft International Standard 15197.2, In vitro diagnostic systems —Requirements for in vitro blood glucose monitoring systems for self-testing in managing diabetes mellitus. Geneva, Switzerland: ISO; 2001.
FDA
 FDA:1989U.S. Food and Drug Administration. Review criteria for assessment of portable invasive blood glucose monitoring in vitro diagnostic devices which use glucose oxidase, dehydrogenase, or hexokinase methodology. Silver Spring, Maryland, USA: FDA; 1989. 这里的信息
CLSI/NCCLS
 CLSI:2002Clinical and Laboratory Standards Institute. CLSI C30 A2 Ed. 2 (2002), Point-of-care Blood Glucose Testing in Acute and Chronic Care Facilities. Wayne, Pennsylvania, USA: CLSI; 2002.
 CLSI:1994National Committee for Clinical Laboratory Standards. NCCLS C30 A:1994, Ancillary (bedside) blood glucose testing in acute and chronic care facilities. Wayne, Pennsylvania, USA: CLSI; 1994.
 CLSI:1991National Committee for Clinical Laboratory Standards. NCCLS C30 T:1991, Ancillary (bedside) blood glucose testing in acute and chronic care facilities. Wayne, Pennsylvania, USA: CLSI; 1991.
ADA
 ADA:1996American Diabetes Association. Self-monitoring of blood glucose. Diabetes Care. 1996;19(Suppl 1):S62-S66. doi: 10.2337/diacare.19.1.S62. PMID: 8689936. 这里的信息
 ADA:1994American Diabetes Association. Self-monitoring of blood glucose. Diabetes Care. 1994;17(1):81-6. doi: 10.2337/diacare.17.1.81. PMID: 8112195. 这里的信息
 ADA:1987American Diabetes Association. Consensus statement on self monitoring of blood glucose. Diabetes Care. 1987;10(1):95-9. doi: 10.2337/diacare.10.1.95. PMID: 3552518. 这里的信息
CSA
 CSA:1999Canadian Standards Association. CSA Z316.4-94 (R2000), Performance Specifications for Portable Whole Blood Glucose Monitor Systems for Use in Diabetes Management. Toronto, Ontario, Canada: CSA; 1999. 这里的信息
 CSA:1994Canadian Standards Association. CSA Z316.4-94, Performance Specifications for Portable Whole Blood Glucose Monitor Systems for Use in Diabetes Management. Mississauga, Ontario, Canada: CSA; 1994