Accuracy of the Contour® Next Link 2.4 blood glucose monitoring system in Japanese individuals: a single-center study

被引:0
作者
Katsuki, Takeshi [1 ]
Kondo, Yuko [2 ]
Fujita, Masataka [1 ]
Tanaka, Hajime [1 ]
Suzuki, Rina [2 ]
Takeda, Hiroko [2 ]
Kawai, Toshihide [1 ]
机构
[1] Tokyo Saiseikai Cent Hosp, Dept Internal Med, Minato Ku, 1-4-17 Mita, Tokyo 1080073, Japan
[2] Tokyo Saiseikai Cent Hosp, Dept Clin Lab, Tokyo, Japan
关键词
Contour Next Link 2.4; Continuous glucose monitoring; Japanese; Diabetes mellitus;
D O I
10.1007/s13340-022-00606-w
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Aims Self-monitoring of blood glucose is a useful method for monitoring blood glucose. It is often a key role of a management plan to reduce glycemic variability and diabetic complications. Wireless monitoring systems to connect blood glucose and insulin pumps can facilitate glycemic control. In this study, we evaluated the accuracy of Contour (R) Next Link 2.4, a blood glucose monitoring system that cooperates wirelessly with most insulin pumps, in Japanese individuals. Methods In this study, finger-stick samples from 59 individuals were collected at the Tokyo Saiseikai Central Hospital. Blood glucose concentrations were measured with the monitoring systems against an available reference. We evaluated the accuracy of the system based on the ISO 15197:2013 Section 6.3 accuracy criteria. Results In the present study, 100% of the results fulfilled the ISO 15197:2013 Section 6.3 accuracy criteria (95% within +/- 15 mg/dL or +/- 15% of reference for glucose < 100 and >= 100 mg/dL, respectively). The Parkes-Consensus Error Grid analysis showed that 100% of the results fulfilled within Zone A. Conclusions The Contour (R) Next Link 2.4 blood glucose monitoring system fulfilled the ISO 15197:2013 accuracy criteria limit and the consensus error grid criterion. Therefore, this monitoring system for observing blood glucose levels is accurate for Japanese individuals.
引用
收藏
页码:103 / 108
页数:6
相关论文
共 14 条
[1]   Diabetes Technology: Standards of Medical Care in Diabetes-2020 [J].
American Diabetes Association .
DIABETES CARE, 2020, 43 :S77-S88
[2]  
[Anonymous], 2013, ISO 15197:2013
[3]   Accuracy and user performance evaluation of the Contour® Next Link 2.4 blood glucose monitoring system [J].
Bailey, Timothy ;
Wallace, Jane F. ;
Greene, Carmine ;
Pardo, Scott ;
Brown, Daniel ;
Pflug, Brian ;
Klaff, Leslie J. .
CLINICA CHIMICA ACTA, 2015, 448 :139-145
[4]   Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range [J].
Battelino, Tadej ;
Danne, Thomas ;
Bergenstal, Richard M. ;
Amiel, Stephanie A. ;
Beck, Roy ;
Biester, Torben ;
Bosi, Emanuele ;
Buckingham, Bruce A. ;
Cefalu, William T. ;
Close, Kelly L. ;
Cobelli, Claudio ;
Dassau, Eyal ;
DeVries, J. Hans ;
Donaghue, Kim C. ;
Dovc, Klemen ;
Doyle, Francis J. ;
Garg, Satish ;
Grunberger, George ;
Heller, Simon ;
Heinemann, Lutz ;
Hirsch, Irl B. ;
Hovorka, Roman ;
Jia, Weiping ;
Kordonouri, Olga ;
Kovatchev, Boris ;
Kowalski, Aaron ;
Laffel, Lori ;
Levine, Brian ;
Mayorov, Alexander ;
Mathieu, Chantal ;
Murphy, Helen R. ;
Nimri, Revital ;
Norgaard, Kirsten ;
Parkin, Christopher G. ;
Renard, Eric ;
Rodbard, David ;
Saboo, Banshi ;
Schatz, Desmond ;
Stoner, Keaton ;
Urakami, Tatsuiko ;
Weinzimer, Stuart A. ;
Phillip, Moshe .
DIABETES CARE, 2019, 42 (08) :1593-1603
[5]   The Association of Biochemical Hypoglycemia with the Subsequent Risk of a Severe Hypoglycemic Event: Analysis of the DCCT Data Set [J].
Beck, Roy W. ;
Bergenstal, Richard M. ;
Riddlesworth, Tonya D. ;
Kollman, Craig .
DIABETES TECHNOLOGY & THERAPEUTICS, 2019, 21 (01) :1-5
[6]   Validation of Time in Range as an Outcome Measure for Diabetes Clinical Trials [J].
Beck, Roy W. ;
Bergenstal, Richard M. ;
Riddlesworth, Tonya D. ;
Kollman, Craig ;
Li, Zhaomian ;
Brown, Adam S. ;
Close, Kelly L. .
DIABETES CARE, 2019, 42 (03) :400-405
[7]  
Bedini Jose Luis, 2015, J Diabetes Sci Technol, V10, P85, DOI 10.1177/1932296815609368
[8]  
International Diabetes Federation, 2019, Diabetes Atlas, V9th
[9]   Self-monitoring of blood glucose in type 2 diabetes and long-term outcome: an epidemiological cohort study [J].
Martin, S ;
Schneider, B ;
Heinemann, L ;
Lodwig, V ;
Kurth, HJ ;
Kolb, H ;
Scherbaum, W .
DIABETOLOGIA, 2006, 49 (02) :271-278
[10]   A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose [J].
Parkes, JL ;
Slatin, SL ;
Pardo, S ;
Ginsberg, BH .
DIABETES CARE, 2000, 23 (08) :1143-1148