ArticleJournal of diabetes science and technology2015
Performance and System Validation of a New Cellular-Enabled Blood Glucose Monitoring System Using a New Standard Reference Measurement Procedure of Isotope Dilution UPLC-MRM Mass Spectrometry.
Article in Journal of diabetes science and technology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
2 citing papers in PubMed.
- Commercial Translation of Electrochemical Biosensors: Supply Chain Strategy, Scale-Up Manufacturing, and Regulatory-Quality Considerations.Biosensors · 2026Review
- Development and Validation of a Rapid (13)C6-Glucose Isotope Dilution UPLC-MRM Mass Spectrometry Method for Use in Determining System Accuracy and Performance of Blood Glucose Monitoring Devices.Journal of diabetes science and technology · 2015Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundWe evaluated the accuracy, precision, and linearity of the In Touch blood glucose monitoring system (BGMS), a new color touch screen and cellular-enabled blood glucose meter, using a new rapid, highly precise and accurate (13)C6 isotope-dilution liquid chromatography-mass spectrometry method (IDLC-MS).
methodsBlood glucose measurements from the In Touch BGMS were referenced to a validated UPLC-MRM standard reference measurement procedure previously shown to be highly accurate and precise. Readings from the In Touch BGMS were taken over the blood glucose range of 24-640 mg/dL using 12 concentrations of blood glucose. Ten In Touch BGMS and 3 lots of test strips were used with 10 replicates at each concentration. A lay user study was also performed to assess the ease of use.
resultsAt blood glucose concentrations <75 mg/dL 100% of the measurements are within ±8 mg/dL from the true reference standard; at blood glucose levels >75 mg/dL 100% of the measurements are within ±15% of the true reference standard. 100% of the results are within category A of the consensus grid. Within-run precision show CV < 3.72% between 24-50 mg/dL and CV<2.22% between 500 and 600 mg/dL. The results show that the In Touch meter exceeds the minimum criteria of both the ISO 15197:2003 and ISO 15197:2013 standards. The results from a user panel show that 100% of the respondents reported that the color touch screen, with its graphic user interface (GUI), is well labeled and easy to navigate.
conclusionsTo our knowledge this is the first touch screen glucose meter and the first study where accuracy of a new BGMS has been measured against a true primary reference standard, namely IDLC-MS.
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