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血糖仪

根据国际糖尿病联合会的统计,到2015年,全球有4.5亿人(超过9%的全球人口)在2015年患有糖尿病,另有3.18亿人患有2型糖尿病。

据估计,每六秒就有一人死于糖尿病,并且2015年有500万人死于糖尿病。令人担忧的是,该流行病并没有显示出缓解的迹象,到2040年,预计糖尿病患者人数将达到6.42亿。

血糖仪的准确性

血糖仪验证的发展

如下所列,独立验证血糖仪的方案是由美国糖尿病协会于1987年发起的。若干组织,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,其中许多标准进行了修订。除了2013 CLSI标准之外,其中大部分已经被撤销或取代。 ISO与CEN一起制定了2000年的标准草案15197,该标准于2002年完成并于2003年和2013年进行了修订。2015年,Klonoff等人最近提出了新的验证程序。 [2]错误网格

错误网格分析,量化血糖仪自我测量误差水平对参考测量的潜在危害,首先由Clarke等人于1987年提出,网格在论文中描述,被称为Clarke误差格。 [3] Parkes等人。 2000年出版了另一种共识误差网格(也称为Parkes误差网格)[4],现在它构成ISO 15197:2013的一部分。 Klonoff等人在2014年描述了监视误差网格[5]。

血糖仪的准确性 - 参考文献

参考

  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.
血糖仪验证协议

当前协议

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