Randomized, Open-Label, Parallel Group Study to Evaluate the Effect of Internet-Based Glucose Management System on Subjects with Diabetes in China

Abstract

Objective: Large amounts of time and effort are needed to implement an Internet-based glucose monitoring system (IBGMS) in the clinical setting. This study was designed using research experience that was developed while implementing an IBGMS in Korea, and the research platform was modified to evaluate the efficacy of an IBGMS in controlling blood sugar in the Chinese population.

Methods: A randomized, open-label, parallel group design was used to evaluate the efficacy of an IBGMS among Chinese subjects with type 2 diabetes. Over a 6-month period, 182 subjects were evaluated in the IBGMS (n = 92) or control (n = 90) groups.

Results: After 3 months, the control group's HbA1c levels were reduced from 8.0% ± 0.8% to 7.3% ± 1.2% (p < 0.001) and the IBGMS group experienced a reduction from 7.9% ± 0.8% to 6.9% ± 0.7% (p < 0.001); the IBGMS group's end value was significantly lower (p = 0.014). The intragroup changes in the control and IBGMS groups were significant at the 3-month (p = 0.002) and 6-month (p < 0.01) follow-ups. Over this period, the HbA1c levels in the control group increased slightly (7.3% ± 1.1% to 7.4% ± 1.3%, p = 0.605), and the HbA1c levels in the IBGMS group decreased slightly (6.9% ± 0.7% to 6.7% ± 0.7%, p = 0.081).

Conclusions: The IBGMS was effective in improving blood sugar levels among patients with diabetes. Therefore, IBGMS experience can be effectively transferred between institutions and countries.

Keywords: Diabetes mellitus; Internet-based glucose monitoring system (IBGMS); mobile health; telehealth.