Performance Evaluation of the Glunovo® Continuous Blood Glucose Monitoring System in Chinese Participants with Diabetes: A Multicenter, Self-Controlled Trial

Abstract

Introduction The present study was aimed to evaluate the performance and safety of the Glunovo® real-time continuous glucose monitoring system (CGMS) in monitoring interstitial fluid glucose in adult participants with diabetes (at least 18 years old) using venous blood glucose as control. Methods This was a multicenter, self-controlled clinical trial, conducted in participants with diabetes from China, between March 2019 to October 2019. The CGMS was used by all the participants for a 14-day wear-in period. The real-time glucose values measured by Glunovo® CGMS were compared with venous blood glucose values measured by the Entwicklung, Konstruktion und Fertigung (EKF) blood glucose detector. The primary outcomes were the consistency rate of CGMS readings and venous blood glucose values (20/20% standard). Results A total of 78 participants (41 men, 37 women) and 156 CGMS sensors were included in the study. Among the included participants, 25 and 53 participants had type 1 and type 2 diabetes, respectively, with median age of 52.50 years (range 32–62 years). The overall agreement rate (20/20%) was 89.71% (95% CI 89.18–90.24%). It was observed that 99.08% (95% CI 98.91–99.24%) and 99.82% (95% CI 99.74–99.89%) of the measuring points fell within the A + B zones of the Clarke error grid analysis and Parkes/consensus error grid analysis, respectively. The mean absolute relative difference was 10.30% ± 4.86%. The probability of a glucose measurement falling within a range, when stratified by venous glucose measurements, ranged from 7.14% for 19.44–22.22 mmol/L to 79.21% for 4.44–6.67 mmol/L. There were 73 (41.24%) and 27 (57.45%) successful CGMS alarms for hypoglycemic and hyperglycemic events, respectively. Conclusion From the results, Glunovo® CGMS had excellent accuracy and limited clinical risk compared with venous blood glucose in the range of 2.2–22.2 mmol/L over 14 days. Supplementary Information The online version contains supplementary material available at 10.1007/s13300-021-01171-2.

Accuracy of a novel real-time continuous glucose monitoring system: a prospective self-controlled study in thirty hospitalized patients with type 2 diabetes

“…It generates electrical signals, which are transmitted to the mobile application for display of blood glucose readings. While previous studies have indicated the stability and repeatability of Glunovo ® , there remains a lack of head-to-head research to evaluate its accuracy ( 7 ). To address this gap, we conducted a head-to-head study to assess the accuracy of Glunovo ® .…”

A Critical Discussion of Alert Evaluations in the Context of Continuous Glucose Monitoring System Performance

“…In total, 34 articles identified in the review1 addressed alert evaluation (Supplemental Table), 12-45 and 29 of these reported how alerts were assessed: In 15 of these 29 articles, the alert evaluation was based on individual values, 12-26 6 articles assessed episodes, 27-32 2 articles assessed both episodes and values, 33,34 and 6 seemed to use actually recorded alerts with a value-based approach. 35-40 Especially in the latter case, the language was often not sufficiently clear to make a definitive statement.…”

“…In total, 34 articles identified in the review1 addressed alert evaluation (Supplemental Table), 12-45 and 29 of these reported how alerts were assessed: In 15 of these 29 articles, the alert evaluation was based on individual values, 12-26 6 articles assessed episodes, 27-32 2 articles assessed both episodes and values, 33,34 and 6 seemed to use actually recorded alerts with a value-based approach. 35-40 Especially in the latter case, the language was often not sufficiently clear to make a definitive statement. Notably, there were articles, where the wording “events” was used, while the reported dat...…”

Professional continuous glucose monitoring in patients with diabetes mellitus: A systematic review and meta‐analysis

“…Three alternative p‐CGM systems are currently available on the market, each with slightly different technical characteristics (Table S1). 8,9 Of note, the patient is blinded to sensor glucose readings and does not receive any glucose‐related alert or notification while wearing a p‐CGM device, therefore, the HCP can view results that have not been influenced by a patient's decisions in real time 10 . The availability of unbiased glucose data is expected to improve the HCP's understanding of the diverse factors possibly affecting the patient's glycaemic control and guide more appropriate therapeutic intervention, including changes in diet, physical activity (PA), and medications 6 .…”