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2024, Vol: 8, Issue: 4
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Original Article

Online Publishing Date:
25 / 03 / 2021

 


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

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.

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


 
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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. https://www.ijmdc.com/?mno=48260 [Access: March 29, 2024]. 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 March 29, 2024]; 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




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