An internet-enabled blood glucose meter (MyGlucoHealth) does not meet the analytical accuracy level required by International Organization for Standardization (ISO) 15197:2015 or Food and Drug Administration (FDA) guidelines, according to study results published in the Journal of Diabetes Science and Technology.
In randomized clinical trials, researchers noted an unusual reporting pattern of glycemic data and hypoglycemic events that they believed was linked to the blood glucose data detection system. In this study, they sought to evaluate the accuracy of the MyGlucoHealth blood glucose meter and whether it met the standards established by the ISO or FDA.
The study included 10 of 3088 glucose meters and 6 of 23 strip lots used in the randomized clinical trials. The researchers used the YSI 2300 STAT Plus glucose analyzer as the standard reference method. They distributed capillary blood samples according to ISO 15197:2015 blood glucose distribution categories along with 20 samples in the hypoglycemic range (50-80 mg/dL) and tested each sample with 6 devices and 6 strip lots with double determinations.
From 121 participants with blood glucose values 26 to 423 mg/dL, the researchers collected 1452 data points to compare the MyGlucoHealth blood glucose meter to the YSI reference values. Out of these, 12.8% (n = 186) did not meet ISO acceptance criteria. When evaluated according to FDA guidelines, that percentage rose to 23.1% (n = 336).
The results indicated a clear bias toward falsely elevated values for blood glucose <100 mg/dL (mean absolute relative deviation, 11.0%).
“These observations are concerning with regards to patient safety since overestimation of [blood glucose] levels in this range may result in a false perception of the real glycemic control,” wrote the researchers. “Hence device manufacturers should be mandated to provide actualized performance data on a regular basis in order to ensure patient safety and to facilitate selection of devices for routine treatment and for clinical trials.”
Disclosure: Novo Norodisk A/S funded this study.
Pfützner A, Demircik F, Kirsch V, et al. System accuracy assessment of a blood glucose meter with wireless internet access associated with unusual hypoglycemia patterns in clinical trials [published online April 11, 2019]. J Diabetes Sci Technol. doi:10.1177/1932296819841353