ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2021
Performance Evaluation of the Glunovo® Continuous Blood Glucose Monitoring System in Chinese Participants with Diabetes: A Multicenter, Self-Controlled Trial.
Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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Who cites it
6 citing papers in PubMed, 11 citations in OpenAlex.
- International clinical opinion on transparency, standardisation, and calibration alignment in the performance evaluation of systems for continuous glucose monitoring.Diabetes, obesity & metabolism · 2026Review
- A new glucose monitoring system for the intermittent monitoring of interstitial glucose values in patients with diabetes mellitus.Journal of diabetes and metabolic disorders · 2024Article
- A Critical Discussion of Alert Evaluations in the Context of Continuous Glucose Monitoring System Performance.Journal of diabetes science and technology · 2024Review
- Evaluating the precision and reliability of real-time continuous glucose monitoring systems in ambulatory settings: a systematic review.Therapeutic advances in endocrinology and metabolism · 2024Review
- Accuracy of a novel real-time continuous glucose monitoring system: a prospective self-controlled study in thirty hospitalized patients with type 2 diabetes.Frontiers in endocrinology · 2024Article
- Clinical Performance Evaluation of Continuous Glucose Monitoring Systems: A Scoping Review and Recommendations for Reporting.Journal of diabetes science and technology · 2023Article
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Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThe 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.
methodsThis 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).
resultsA 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.
conclusionFrom 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.
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