A Prospective Multicenter Clinical Performance Evaluation of the C-CGM System

Continuous glucose monitors (CGMs) have had a significant impact on the management of diabetes mellitus. We present the results of a multinational evaluation of the Cascade CGM ("C-CGM") over 14 days of in-clinic and home use. Each of the 57 enrolled type 1 diabetes mellitus and type 2 dia...

Full description

Saved in:

Bibliographic Details
Published in:	Journal of diabetes science and technology Vol. 16; no. 2; p. 390
Main Authors:	Rebec, Mihailo, Cai, Kevin, Dutt-Ballerstadt, Ralph, Anderson, Ellen
Format:	Journal Article
Language:	English
Published:	United States 01.03.2022
Subjects:	Blood Glucose - analysis Blood Glucose Self-Monitoring Diabetes Mellitus, Type 1 - drug therapy Diabetes Mellitus, Type 2 Humans Reproducibility of Results diabetes therapy continuous glucose monitoring CGMS diabetes glucose oxidase
ISSN:	1932-2968, 1932-3107
Online Access:	Get more information
Tags:	Add Tag No Tags, Be the first to tag this record!

Description
Summary:	Continuous glucose monitors (CGMs) have had a significant impact on the management of diabetes mellitus. We present the results of a multinational evaluation of the Cascade CGM ("C-CGM") over 14 days of in-clinic and home use. Each of the 57 enrolled type 1 diabetes mellitus and type 2 diabetes mellitus subjects wore 2 C-CGMs on the abdomen for 14 days. One part of the evaluation was the performance versus reference glucose values generated for 12 -hour in-clinic sessions on days 1, 4, 7, 10, and 14. Glucose blood samples were drawn every 15 minutes and analyzed with the Yellow Spring Instruments (YSI) 2300 glucose analyzer. The performance assessment on in-clinic days was based on paired YSI/CGM data points and on home-use days was based on paired fingerstick BGM (blood glucose monitoring)/CGM data points. A total of 17 823 CGM/YSI data points during in-clinic use was analyzed. The mean absolute relative difference for glucose values between 100 and 400 mg/dL (MARD) and mean absolute difference for values between 40 and 100 mg/dL (MAD) were 11.5% and 15.1 mg/dL, respectively. The system accuracy during home use was 12.7% and 15 mg/dL for MARD and MAD, respectively. There were no serious adverse events or infectious complications reported. A modified algorithm "Hybrid Algorithm" was used in a prospective analysis of the in-clinic data, resulting in a MARD of 9.9% and MAD of 14.5 mg/dL. The performance of the C-CGM device over 14 days meets the safety and efficacy standards of CGM systems for managing blood glucose levels in people with diabetes. This was further confirmed when the C-CGM system was given approval for CE Mark in October 2019.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	1932-2968 1932-3107
DOI:	10.1177/1932296820964574