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血糖仪

根据国际糖尿病联合会的数据,2015年,全球有4.15亿人(占全球人口的9%以上)在2015年患有糖尿病,另有3.18亿人患有2型糖尿病的风险很高。

据估计,每6秒就有一人死于糖尿病,2015年有500万人死于糖尿病。令人担忧的是,这种流行病没有出现任何缓和的迹象,预计到2040年糖尿病患者人数将达到6.42亿。 。

血糖仪的准确性

开发血糖仪验证

如下所列,美国糖尿病协会于1987年启动了独立验证血糖仪的协议。一些组织,包括FDA,加拿大标准协会和美国临床和实验室标准研究所(或国家临床实验室委员会) 2005年之前已知的标准也制定了验证标准,其中许多标准已经过修订。除了2013年的CLSI标准外,其中大部分已被撤销或取代。 ISO与CEN一起制定了2000年的标准草案15197,该草案于2002年完成,并于2003年和2013年进行了修订。最近一次新的验证程序要求由Klonoff等人于2015年提出。[2]错误网格

误差网格分析,用于量化血糖仪中自测量误差水平的潜在危害,与参考测量相比,由Clarke等人于1987年首次假设,网格中描述了网格,称为Clarke误差格。 [3]帕克斯等人。在2000年发布了另一种共识误差网格,也称为帕克斯误差网格[4],现在它已成为ISO 15197:2013的一部分。 Klonoff等人在2014年描述了一个监视误差网格[5]。

血糖仪的准确性 - 参考文献

References

  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. Download here.
  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. Download here.
  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. Download here.
血糖仪的验证协议

现行议定书

ISO/IEC/CEN/DIN

15197:2013

International Organization for Standardization Technical Committees ISO/TC 212 and ISO/TC 140. EN 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.

DTS

DTS:2016

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. PMID: 26481642. Download here

FDA

FDA:2016P

US 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. Download here

FDA:2016H

US 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. Download here

CLSI

CLSI:2013

Clinical 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.

Previous Protocols

ISO/IEC/CEN/DIN

15197:2003

International 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. Information here

15197:2002

International 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 Geneva, Switzerland: ISO; 2002.

FDA

FDA:1989

U.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. Information here

CLSI/NCCLS

CLSI:2002

Clinical 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:1994

National 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:1991

National 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:1996

American Diabetes Association. Self-monitoring of blood glucose. Diabetes Care. 1996;19(Suppl 1):S62-S66. doi: 10.2337/diacare.19.1.S62. PMID: 8689936. Information here

ADA:1994

American Diabetes Association. Self-monitoring of blood glucose. Diabetes Care. 1994;17(1):81-6. doi: 10.2337/diacare.17.1.81. PMID: 8112195. Information here

ADA:1987

American 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. Information here

CSA

CSA:1999

Canadian Standards Association. CSA Z316.4-94 (R2000), Performance Specifications for Portable Whole Blood Glucose Monitor Systems for Use in Diabetes Management. Totonto, Ontario, Canada: CSA; 1999. Information here

CSA:1994

Canadian 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