Accuracy Assessment of a Blood Glucose Monitoring System for Self-Testing with Three Test Strip Lots Following ISO 15197:2013/EN ISO 15197:2015

Breitenbeck, Nancy; Brown, Amy Frances

doi:10.1177/1932296816682032

Cited by 4 publications

(2 citation statements)

References 1 publication

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“…The importance of this standard and the European version EN ISO 15197:2015 is the establishment of rules about the acceptable performance of blood glucose monitoring devices. The standard states that readings from the device shall fall within ±15 mg/dL of the average values measured with the comparison method for blood glucose concentrations <100 mg/dL and within ±15 % for blood glucose concentrations ≥100 mg/dL for at least 95% of the system's results (Breitenbeck et al, 2017).…”

Section: Validationmentioning

confidence: 99%

Experimental blood glucose estimation from photoplethysmography recordings on distal finger phalange

Campos

Sotelo-Orozco

Gamboa

et al. 2022

ICBI

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Blood glucose concentration shows the quality and health of an individual. High glucose levels in the blood flow indicate atypical behavior of the human system. Currently, there is an acceptable test method to estimate glucose level; it consists in taking out a blood sample by the finger with a pin prick. However, the blood sample test has some disadvantages because it can produce some non-desired issues, such as infections, especially a typical case in people living with diabetes. Therefore, this work is motivated by applying reflective Photoplethysmography (PPG), a non-invasive technique based on a light source and a photodetector near the human body's skin. In this case, we propose two different blood glucose sensors using the infrared diodes LTE-302 and COM-09349 with a photodetector FDS-100. It is worth noting that both designs have multiple development stages, and all of them are self-designed and validated through various test samples with three healthy volunteers, one woman and two men. The results present an error of about 14 % for the first sensor, while for the second sensor is about 7.9 %. Moreover, the sensor measurements are compared against a commercial glucometer, the One Touch Select Plus Flex, and the specifications of the NORM ISO 15197:2013 standard. Finally, the reflective PPG technique could be applied as a non-invasive method to estimate the blood glucose level in the human body.

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Section: Validationmentioning

confidence: 99%

Experimental blood glucose estimation from photoplethysmography recordings on distal finger phalange

Campos

Sotelo-Orozco

Gamboa

et al. 2022

ICBI

View full text Add to dashboard Cite

show abstract

“…Different systems for SMBG are constantly evaluated for interactions with potentially interfering substances. 2,3 Such clinically relevant interferences show up with a number of widely used drugs, to a degree that has implications for diabetes management of patients with DM. 2,[4][5][6] To ensure safety and efficacy of SMBG, interferences should be tested especially for newer classes of clinically used drugs patients with DM might be exposed to.…”

mentioning

confidence: 99%

Patients With SGLT2 Inhibitor Therapy Can Reliably Measure Their Blood Glucose Without Interference Issues When Up-to-Date Potentiometric and Amperometric Blood Glucose Measurement Systems Are Used

Mills

Roetschke²

2021

J Diabetes Sci Technol

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Accuracy of a continuous glucose monitoring system applied before, during, and after an intense leg-squat session with low- and high-carbohydrate availability in young adults without diabetes

Matzka,

Ørtenblad,

Lenk

et al. 2024

Eur J Appl Physiol

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Purpose The aim was to assess the accuracy of a continuous blood glucose monitoring (CGM) device (Abbott FreeStyle Libre 3) against capillary blood glucose measurement (BGM) before, during, and after an intense lower body strength training session in connection with high- versus low-carbohydrate breakfasts. Methods Nine adults (22 ± 2 years) completed a strength training session (10 × 10 at 60% 1RM) twice after high-carbohydrate and twice after low-carbohydrate breakfasts. CGM accuracy versus BGM was assessed across four phases: post-breakfast, pre-exercise, exercise, and post-exercise. Results Overall fed state mean BGM levels were 84.4 ± 20.6 mg/dL. Group-level Bland–Altman analysis showed acceptable agreement between CGM and BGM across all phases, with mean biases between − 7.95 and − 17.83 mg/dL; the largest discrepancy was in the post-exercise phase. Mean absolute relative difference was significantly higher post-exercise compared to pre-exercise and exercise phases, for overall data and after the high-carbohydrate breakfast (all p ≤ 0.02). Clark Error Grid analysis showed 50.5–64.3% in Zone A and 31.7–44.6% in Zone B, with an increase in treatment errors during and after exercise. Conclusion In this group of healthy participants undergoing strength training, CGM showed satisfactory accuracy in glucose monitoring but varied substantially between individuals compared to BGM and fails in meeting clinical criteria for diabetic monitoring. CGM could aid non-diabetic athletes by tracking glucose fluctuations due to diet and exercise. Although utilization of CGM shows potential in gathering, analyzing, and interpreting interstitial glucose for improving performance, the application in sports nutrition is not yet validated, and challenges in data interpretation could limit its adoption.

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Accuracy Assessment of a Blood Glucose Monitoring System for Self-Testing with Three Test Strip Lots Following ISO 15197:2013/EN ISO 15197:2015

Cited by 4 publications

References 1 publication

Experimental blood glucose estimation from photoplethysmography recordings on distal finger phalange

Experimental blood glucose estimation from photoplethysmography recordings on distal finger phalange

Patients With SGLT2 Inhibitor Therapy Can Reliably Measure Their Blood Glucose Without Interference Issues When Up-to-Date Potentiometric and Amperometric Blood Glucose Measurement Systems Are Used

Accuracy of a continuous glucose monitoring system applied before, during, and after an intense leg-squat session with low- and high-carbohydrate availability in young adults without diabetes

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