Abstract

Background: egm1000™ is a Conformité Européene-mark approved non-invasive glucose monitoring device intended for home use and in-door environment. The purpose of this post marketing clinical study is to demonstrate the performance of egm1000™ in measuring glucose levels in patients with type 2 diabetes and prediabetic patients, when operated according to the manufacturer’s instructions for use, and by comparison to capillary blood glucose levels using Accu-Chek® Performa.
Methods: This is a combined, open label, prospective, comparative, single-center trial. The study was conducted at the Department of Medicine, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia. One hundred and eighty-eight paired measurements from 36 type 2 diabetes patients and 11 prediabetic ones were performed and evaluated by Consensus Error Grid Analysis. The study duration was 2 months, and was conducted between July 2018 and August 2018.
Results: Results showed that 100% of all egm1000™data points were within the clinically acceptable zones A and B. Furthermore, 100% of the performance evaluation participants’ data points were within the clinically acceptable zones of the Consensus Error Grid (A + B: 94.7% + 5.3%), respectively. Mean absolute relative difference of the egm1000™ devices was found to be 13.8%.
Conclusion: We conclude that our real-world study showed an overall accuracy, which is comparable to previously published results from more standardized regulatory experiments.

Key words: Diabetes mellitus, blood glucose monitoring, egm1000™, home monitoring