ArticleJournal of diabetes science and technology2020
System Accuracy Assessment of a Combined Invasive and Noninvasive Glucometer.
Article in Journal of diabetes science and technology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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Who cites it
5 citing papers in PubMed.
- Development of sensor system and data analytic framework for non-invasive blood glucose prediction.Scientific reports · 2024Article
- Patent analysis of digital sensors for continuous glucose monitoring.Frontiers in public health · 2023Review
- Technologies for Diabetes Self-Monitoring: A Scoping Review and Assessment Using the REASSURED Criteria.Journal of diabetes science and technology · 2022Article
- Products for Monitoring Glucose Levels in the Human Body With Noninvasive Optical, Noninvasive Fluid Sampling, or Minimally Invasive Technologies.Journal of diabetes science and technology · 2022Review
- Noninvasive, wearable, and tunable electromagnetic multisensing system for continuous glucose monitoring, mimicking vasculature anatomy.Science advances · 2020Article
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe pain associated with pricking the fingertip for blood glucose self-testing is considered to be a major burden in diabetes treatment. This study was performed to evaluate the system accuracy of the invasive TensorTip Combo Glucometer (CoG) device component in accordance with ISO15197:2015 requirements and to explore the accuracy of the noninvasive tissue glucose prediction component.
methodsOne hundred samples were obtained from people with type 1 and type 2 diabetes and healthy volunteers (43 females, 57 males; age: 53 ± 16 years), with glucose distribution as requested by the ISO standard. Three strip lots were tested twice by healthcare professionals in comparison to YSI 2300 Stat Plus reference method followed by a noninvasive tissue glucose reading (NI-CoG). Mean Absolute (Relative) Difference (MARD) was calculated and a consensus error grid (CEG) analysis was performed.
resultsThe ISO system accuracy criteria were met with the invasive strip technology by 586/600 of the data points (97.1%) and for each strip lot separately. All invasive results (100%) were within CEG-zone A and total MARD was calculated to be 7.1%. With the noninvasive reading, 99% of raw data points were in A + B (91.1% and 7.8%), and the total MARD was calculated to be 18.1%. DISCUSSION: The invasive component of the CoG device was shown to be in full compliance with the current ISO15197 criteria. Good results were also obtained with the NI-CoG tissue glucose prediction. This noninvasive technology would potentially be suitable for frequent pain-free glucose monitoring in many people with diabetes.
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