Clinical Performance of a Novel 15.5-Day Factory-Calibrated Continuous Glucose Monitoring System in Adults With Diabetes

Abstract

Background:

Performance of the uCGM 100 continuous glucose monitoring (CGM) system, featuring a 15.5-day, real-time, and factory-calibrated glucose sensor, is evaluated against venous plasma reference for adult participants (≥18 years) in a multicenter, prospective clinical study.

Methods:

A total number of 60 participants were enrolled at three clinical sites in China, and each participant wore sensors on the back of each upper arm for 15.5 days. Three in-clinic visits, lasting eight hours during each visit, were conducted by each participant to perform multiple venous plasma glucose measurements using Biosen C-Line GP+ (EKF Diagnostics) Glucose/Lactate Measuring System. Venous plasma blood glucose sample tests covered the start, middle, and end wear of the sensor (day 1, days 3-5, days 7-9, days 11-13, or the last 24 hours). Analytic performance included accuracy such as ±20% or ±20 mg/dL (%20/20) agreement rate with reference values, and mean absolute relative difference (MARD) between CGM and reference values.

Results:

A total of 11 576 matched data pairs (120 sensors) were analyzed. The overall MARD and %20/20 agreement rate for the CGM system was 7.6% and 95.5%, respectively, compared with venous blood reference. The %20/20 agreement remained consistently above 93% across wear days and glucose ranges. No serious adverse events were recorded. Usability survey showed 99.8% positive feedback, demonstrating good usability.

Conclusions:

The novel CGM system was proven to provide accurate and reliable glucose readings in adults with diabetes.