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Accuracy evaluation of blood glucose monitoring systems in children on overnight closed-loop control

Daniel J DeSalvo1, Satya Shanmugham1, Trang T Ly1

  • 1Stanford University School of Medicine, Stanford, CA, USA.

Journal of Diabetes Science and Technology
|May 31, 2014
PubMed

Insights

The Bayer Contour® Next (CN) glucose meter showed superior accuracy compared to the HemoCue® (HC) system in children with type 1 diabetes during overnight studies. CN met all accuracy standards, making it ideal for future research.

Area of Science:

  • Pediatric Endocrinology
  • Medical Device Technology
  • Diabetes Management

Background:

  • Accurate glucose monitoring is crucial for managing type 1 diabetes, especially in children.
  • Overnight closed-loop studies require reliable glucose monitoring systems for safety and data integrity.
  • Evaluating the accuracy of different glucose monitoring systems is essential for clinical research.

Purpose of the Study:

  • To compare the accuracy of the Bayer Contour® Next (CN) and HemoCue® (HC) glucose monitoring systems.
  • To assess system performance against Yellow Springs Instrument (YSI) plasma reference values.
  • To determine suitability of these systems for overnight closed-loop studies in pediatric type 1 diabetes patients.

Main Methods:

  • Pilot study involving 28 children (10-18 years) with type 1 diabetes in a clinical research center.
  • Continuous glucose measurements obtained every 30 minutes overnight.
  • Comparison of whole blood glucose readings (CN, HC) with plasma reference values (YSI) using Mean Absolute Relative Difference (MARD) and International Organization for Standardization (ISO) criteria.

Main Results:

  • The CN system demonstrated significantly better accuracy than the HC system (MARD 3.13% vs. 10.73%, P < .001).
  • The CN system met ISO 2003 and 2013 accuracy standards across all glucose ranges.
  • The HC system did not meet ISO accuracy criteria within the study's limited sample size.

Conclusions:

  • The Bayer Contour® Next glucose monitoring system exhibits high accuracy and reliability in pediatric type 1 diabetes patients.
  • CN is a suitable and recommended device for use in overnight closed-loop studies, even outside of a research setting.
  • Further research may be warranted to explore HC system performance under different conditions.

Keywords:
Contour NextHemoCueYSIaccuracyblood glucoseblood glucose meterclosed-loop

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