A post-marketing clinical study of the Sibionics continuous glucose monitoring (CGM) system has been launched at the clinical base of Bogomolets National Medical University. The study focuses on patients with prediabetes and newly diagnosed type 2 diabetes mellitus.
The aim of the study is to evaluate systems effectiveness by comparing it with traditional blood glucose meters, as well as to assess its impact on patients’ daily lives. The research team is analyzing how continuous access to glucose data influences nutrition, physical activity levels, and self-monitoring. The study also examines whether continuous monitoring contributes to more stable glycemic control at the early stages of carbohydrate metabolism disorders. The project has already entered its practical phase: participants are undergoing monitoring, and specialists are analyzing the first data collected.
A total of 160 participants are planned to be enrolled in the study. Some of them use the Sibionics CGM system for 28 days, while others rely on conventional glucometers. The observation period lasts three months and includes laboratory tests and comparison of key indicators — glycated hemoglobin (HbA1c), fructosamine, C-peptide — as well as changes in body composition assessed by bioimpedance analysis and daily physical activity levels.
The Sibionics CGM system measures glucose levels in interstitial fluid in real time and transmits the data to a mobile application. This format enables the creation of a continuous glycemic profile without the need for repeated finger pricks, making glucose control more comfortable and more informed.
Special attention within the project is given to post-marketing surveillance — the collection of data on the device’s performance in real-world conditions and its impact on glycemic control. This allows researchers to assess not only clinical outcomes but also practical aspects of system use and to analyze user experience among participants of different ages with carbohydrate metabolism disorders.
Participation in the study is free of charge for patients. The results will be published after data collection and analysis are complete. They may also serve as a basis for broader implementation of continuous glucose monitoring systems in patients with early-stage carbohydrate metabolism disorders.
In Ukraine, the Sibionics continuous glucose monitoring system is officially represented by COR-Medical, which provides service support and informational assistance to users. To learn more about how real-time glucose monitoring via smartphone works, read the article “Sibionics Glucose Monitoring System”.
