System Accuracy Assessment of a Combined Invasive and Noninvasive Glucometer. (May 2020)

• Record Type: Journal Article
• Authors: Pfützner, Andreas; Demircik, Filiz; Pfützner, Johannes; Kessler, Kim; Strobl, Stephanie; Spatz, Jan; Pfützner, Anke H.; Lier, Alexander
• Is Part Of: Journal of diabetes science and technology. Volume 14:Number 3(2020:May)
• Page Start: 575
• Page End: 581
• Publication Date: 2020-05
• Subjects: noninvasive glucose tissue prediction -- system accuracy -- patient blood glucose self-testing -- invasive blood glucose measurement; Diabetes -- Periodicals; Medical technology -- Periodicals; Diabetes Mellitus -- Periodicals; 616.462005
• DOI: 10.1177/1932296819883306
• Languages: English
• ISSNs: 1932-2968

Abstract

Background: The 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. Methods: One 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. Results: The 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.