ABSTRACT
Background and Aims: There is still a high number of inadequately controlled T2DM patients. Therefore, it is essential to develop innovative solutions to improve patient's empowerment by increasing patient-physician communication and their selfmanagement. The aim of this study was to analyze the effect of a home digital patient empowerment tool (Figure 1), on metabolic control in T2DM patients. Methods: Multicentric, randomized prospective clinical trial including adult T2DM patients without adequate glycemic control treated according to usual clinical practice across Spain. Figure 2 summarizes the study design and study population. The primary endpoint was the comparison of the proportion of patients who did not achieve the study glycemic target (defined as HbA1c levels ≤7.5% with a reduction in HbA1c ≥0.5 from baseline) at week 24 between groups 1 and 2. It was also performed a comparison of mean HbA1c changes from baseline to week 24 between groups 1 and 2. Results: The COVID-19 pandemic led to a premature study closure since patient's enrollment and follow-up were active during the 2020 lockdown. In total, 50 patients completed week 24 visit. Figure 3 shows the main study results. 46% patients from group 1 achieved study glycemic target vs 18% in group 2 (p = 0.067), whereas the difference in the HbA1c reduction between group 1 and 2 was -0.66% (p < 0.05). Conclusions: Our results suggest the patient empowerment through a home digital tool might allow an improvement in metabolic control and consequently a more effective management of T2DM.