Clinical effectiveness of telehealth remote patient monitoring on glycemic control in type 1 and type 2 diabetes: a prospective multicenter study

BACKGROUND: There has been an increasing focus on the use of digital systems for remote monitoring (RM) of patient health recently. AIM: To evaluate the clinical effectiveness of the RM system in patients with type 1 and type 2 diabetes (T1D and T2D) compared to traditional outpatient care. MATERIALS AND METHODS: a non-randomized prospective open comparative multicenter study with parallel groups was conducted in 7 regions of the Russian Federation from March to September 2024. The study included patients with T1D, T2D on non-insulin therapy, and T2D on insulin therapy. The intervention group used a glycaemia RM system, which included a glucometer with a data transmission set, a mobile application that received data from the glucometer via Bluetooth technology, and a data transmission system for the doctor. In the control group, glycemia was assessed as part of routine clinical practice (in-person visits with a self-monitoring diary). RESULTS: A total of 1,572 patients were included in the study. After a 180-day follow-up, the overall completion rate was 48% (754 patients). The primary endpoint, HbA1c levels, decreased comparably in the RM and control groups in patients with T1DM and in both cohorts of patients with T2DM. The proportion of individuals who achieved HbA1c target values was higher in the RM group compared to the control group in patients with T1DM (26.06% vs. 10.91%, respectively, p=0.023) and T2DM on non-insulin therapy (51.5% vs. 33%, respectively, p=0.003). RM use was associated with a reduction in unscheduled medical interventions. CONCLUSION: RM has shown clinical efficacy in increasing the proportion of patients achieving HbA1c target values in the group of patients with T1D and T2D on non-insulin antidiabetic therapy.