Advanced search
Publication Cover
Expert Review of Molecular Diagnostics Volume 19, 2019 - Issue 11
Submit an article Journal homepage
81
Views
1
CrossRef citations to date
0
Altmetric
Original research

System accuracy assessments with a blood glucose meter with combined glucose and ß-hydroxybutyrate measurement capabilities

Sylvia WeissenbacherMED TRUST, Marz, AustriaView further author information
,
Chen-Yu YangNational Yang Ming University, Taipei, TaiwanView further author information
,
Tang-Chin KuanNational Chiao-Tung University, TaiwanView further author information
,
Filiz DemircikPfützner Science & Health Institute, Mainz, GermanyView further author information
,
Mina HannaPfützner Science & Health Institute, Mainz, GermanyView further author information
&
Andreas PfütznerPfützner Science & Health Institute, Mainz, Germany;Department of Biotechnology, Technical University Bonn-Rhein-Sieg, Rheinbach, Germany;Department of Internal Medicine and Laboratory Medicine, University for Digitalized Technologies in Medicine & Dentistry, LuxembourgCorrespondence[email protected]
ORCID Iconhttps://orcid.org/0000-0003-2385-0887View further author information
ORCID Icon
Pages 1043-1048 | Received 10 Jul 2019, Accepted 28 Aug 2019, Published online: 04 Sep 2019

References

  • American Diabetes Association. Glycemic targets. Sec. 6. In Standards of Medical Care in Diabetes—2017. Diabetes Care. 2017;40(Suppl. 1):S48–S56.
  • International Organization for Standardization. In vitro diagnostic test systems: requirements for in vitro blood glucose monitoring systems for self-testing in managing diabetes mellitus. ISO15197:2015. Geneva, Switzerland: International Organization for Standardization; 2015.
  • Parkes JL, Slatin SL, Pardo S, et al. A New Consensus Error Grid to Evaluate the Clinical Significance of Inaccuracies in the Measurement of Blood Glucose. Diabetes Care. 2000;23:1143–1148.
  • Pfützner A, Klonoff DC, Pardo S, et al. Technical aspects of the Parkes error grid. J Diabetes Sci Technol. 2013;7:1275–1281.
  • Burke KR, Schumacher CA, Harpe SE. SGLT2 Inhibitors: A Systematic Review of Diabetic Ketoacidosis and Related Risk Factors in the Primary Literature. Pharmacotherapy. 2017;37:187–194.
  • Pfützner A, Klonoff D, Heinemann L, et al. Euglycemic ketosis in patients with type 2 diabetes on SGLT2-inhibitor therapy - an emerging problem and solutions offered by diabetes technology. Endocrine. 2017;56:212–216.
  • Gibb FW, Teoh WL, Graham J, et al. Risk of death following admission to a UK hospital with diabetic ketoacidosis. Diabetologia. 2016;59:2082–2087.
  • Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986;327:307–310.
  • Passing H, Bablok W. A new biometrical procedure for testing the equality of measurements from two different analytical methods. J Clin Chem Clin Biochem. 1983;21:709–720.
  • Food and Drug Administration: guidance for Industry and Food and Drug Administration staff self-monitoring blood glucose test systems for over-the-counter use. [ updated 2016 Oct 11]. Available from: https://www.fda.gov/downloads/ucm380327.pdf
  • Villena Gonzales W, Mobashsher AT, Abbosh A. The Progress of Glucose Monitoring-A Review of Invasive to Minimally and Non-Invasive Techniques, Devices and Sensors. Sensors (Basel). 2019;19:800.
  • Reiterer F, Polterauer P, Schoemaker M, et al. Significance and Reliability of MARD for the Accuracy of CGM Systems. J Diabetes Sci Technol. 2017;11:59–67.
  • King F, Ahn D, Hsiao V, et al. A Review of Blood Glucose Monitor Accuracy. Diabetes Technol Ther. 2018;20:843–856.
  • Erbach M, Freckmann G, Hinzmann R, et al. Interferences and Limitations in Blood Glucose Self-Testing: an Overview of the Current Knowledge. J Diabetes Sci Technol. 2016;10:1161–1168.
  • Demircik F, Klonoff D, Musholt PB, et al. Successful performance of laboratory investigations with blood glucose meters Employing Dynamic Electrochemistry is dependent on careful sample handling. Diabetes Technol Ther. 2016;18:650–656.
  • Freckmann G, Schmid C, Baumstark A, et al. Analytical performance requirements for systems for self-monitoring of blood glucose with focus on system accuracy: relevant differences among ISO 15197:2003, ISO 15197:2013, and Current FDA Recommendations. J Diabetes Sci Technol. 2015;9:885–894.
  • Philis-Tsimikas A, Stratton I, Nørgård Troelsen L, et al. Efficacy and Safety of Degludec Compared to Glargine 300 Units/mL in Insulin-Experienced Patients With Type 2 Diabetes: trial Protocol Amendment (NCT03078478). J Diabetes Sci Technol. 2019;13:498–506.
  • Pfützner A, Demircik F, Kirsch V, et al. System Accuracy Assessment of a Blood Glucose Meter With Wireless Internet Access Associated With Unusual Hypoglycemia Patterns in Clinical Trials. J Diabetes Sci Technol. 2019;13:507–513.
  • Demircik F, Kirsch V, Ramljak S, et al. Pfützner A Laboratory Evaluation of Linearity, Repeatability, and Hematocrit Interference With an Internet-Enabled Blood Glucose Meter. J Diabetes Sci Technol. 2019;13:514–521.
  • Klonoff DC, Lias C, Beck S, et al. Development of the Diabetes Technology Society Blood Glucose Monitor System Surveillance Protocol. J Diabetes Sci Technol. 2016;10:697–707.
  • Manelli M, Mastorilli C, Fainardi V, et al. Clinical utility of beta-hydroxybutyrate measurement in the management of physiological ketosis at home in children under 5. Acta Biomed. 2019;90:215–220.
  • Vanelli M, Chiari G, Capuano C, et al. The direct measuremenot f 3-B-hydroxybutyrate enhances the management of diabetic ketoacidosis in children and reduces time and costs of treatment. Diab Nutr Metab. 2003;16:312–316.
  • Brooke J, Stiell M, Ojo O. Evaluation of the accuracy of capillary Hydroxybutyrate Measurement Compared with other measurements in the diagnosis of diabetic ketoacidosis: a systematic review. Int J Environ Res Public Health. 2016;23:13.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Order Reprints Request Corporate Permissions

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

Request Academic Permissions

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.

Related research

People also read lists articles that other readers of this article have read.

Recommended articles lists articles that we recommend and is powered by our AI driven recommendation engine.

Cited by lists all citing articles based on Crossref citations.
Articles with the Crossref icon will open in a new tab.