Original Article

IJMDC. 2021; 5(4): 1020-1028

Performance evaluation of egm1000™ non-invasive glucose monitoring device in patients with type 2 diabetes and subjects with prediabetes

Authors: Hala Hisham Mosli, Badr Mohammed Madani.

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.

Keywords:
Diabetes mellitus, blood glucose monitoring, egm1000™, home monitoring


View PDF
Performance evaluation of egm1000™ non-invasive glucose monitoring device in patients with type 2 diabetes and subjects with prediabetes


Authors
Hala Hisham Mosli
Department of Medicine, College of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia
PubMed articlesGoogle scholar articles

Badr Mohammed Madani
Department of Family and Community Medicine, College of Medicine, University of Jeddah, Jeddah, Saudi Arabia
PubMed articlesGoogle scholar articles


Correspondence to:
. Hala H. Mosli, Department of Medicine, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.; halamosli100@gmail.com

Publication history
Received 27 Jan 2021
Revised 12 Mar 2021
Accepted 17 Mar 2021
Published online 25 Mar 2021
Published in print 05 Apr 2021

How to cite this article?

Export to EndNote Export to refMan

Pubmed Style

Mosli HH, Madani BM. Performance evaluation of egm1000™ non-invasive glucose monitoring device in patients with type 2 diabetes and subjects with prediabetes. IJMDC. 2021; 5(4): 1020-1028. doi:10.24911/IJMDC.51-1611360395


Web Style

Mosli HH, Madani BM. Performance evaluation of egm1000™ non-invasive glucose monitoring device in patients with type 2 diabetes and subjects with prediabetes. http://www.ijmdc.com/?mno=48260 [Access: May 08, 2021]. doi:10.24911/IJMDC.51-1611360395


AMA (American Medical Association) Style

Mosli HH, Madani BM. Performance evaluation of egm1000™ non-invasive glucose monitoring device in patients with type 2 diabetes and subjects with prediabetes. IJMDC. 2021; 5(4): 1020-1028. doi:10.24911/IJMDC.51-1611360395


Vancouver/ICMJE Style

Mosli HH, Madani BM. Performance evaluation of egm1000™ non-invasive glucose monitoring device in patients with type 2 diabetes and subjects with prediabetes. IJMDC. (2021), [cited May 08, 2021]; 5(4): 1020-1028. doi:10.24911/IJMDC.51-1611360395


Harvard Style

Mosli, H. H. & Madani, . B. M. (2021) Performance evaluation of egm1000™ non-invasive glucose monitoring device in patients with type 2 diabetes and subjects with prediabetes. IJMDC, 5 (4), 1020-1028. doi:10.24911/IJMDC.51-1611360395


Turabian Style

Mosli, Hala Hisham, and Badr Mohammed Madani. 2021. Performance evaluation of egm1000™ non-invasive glucose monitoring device in patients with type 2 diabetes and subjects with prediabetes. International Journal of Medicine in Developing Countries, 5 (4), 1020-1028. doi:10.24911/IJMDC.51-1611360395


Chicago Style

Mosli, Hala Hisham, and Badr Mohammed Madani. "Performance evaluation of egm1000™ non-invasive glucose monitoring device in patients with type 2 diabetes and subjects with prediabetes." International Journal of Medicine in Developing Countries 5 (2021), 1020-1028. doi:10.24911/IJMDC.51-1611360395


MLA (The Modern Language Association) Style

Mosli, Hala Hisham, and Badr Mohammed Madani. "Performance evaluation of egm1000™ non-invasive glucose monitoring device in patients with type 2 diabetes and subjects with prediabetes." International Journal of Medicine in Developing Countries 5.4 (2021), 1020-1028. Print. doi:10.24911/IJMDC.51-1611360395


APA (American Psychological Association) Style

Mosli, H. H. & Madani, . B. M. (2021) Performance evaluation of egm1000™ non-invasive glucose monitoring device in patients with type 2 diabetes and subjects with prediabetes. International Journal of Medicine in Developing Countries, 5 (4), 1020-1028. doi:10.24911/IJMDC.51-1611360395


Share this article

Click the icon of the social media platform on which you would like to share this article.

Article Statistics

Request permissions

If you wish to reuse any part or all of this article please contact the copyright holder, contact@ijmdc.com.

Copyright ©2021 Discover STM Publishing. All Rights Reserved.