The Effect of a Smartphone-Based, Patient-Centered Diabetes Care System in Patients With Type 2 Diabetes: A Randomized, Controlled Trial for 24 Weeks.

Abstract

This study evaluated the efficacy of a smartphone-based, patient-centered diabetes care system (mDiabetes) for type 2 diabetes that contains comprehensive modules for glucose monitoring, diet, physical activity, and a clinical decision support system. We conducted a 24-week, multicenter, randomized controlled trial with adult patients with inadequately controlled type 2 diabetes. The patients were randomly assigned to the mDiabetes group or the paper logbook (pLogbook) group. The primary end point was the difference of the change in HbA_1c from baseline between the two groups. HbA_1c reduction from baseline was greater in the mDiabetes group (-0.40 ± 0.09%, <i>n</i> = 90) than in the pLogbook group (-0.06 ± 0.10%, <i>n</i> = 82). The difference of adjusted mean changes was 0.35% (95% CI 0.14-0.55, <i>P</i> = 0.001). The proportion of patients whose HbA_1c fell below 7.0% (53 mmol/mol) was 41.1% for the mDiabetes group and 20.7% for the pLogbook group (odds ratio [OR] 2.01, 95% CI 1.24-3.25, <i>P</i> = 0.003). The percentage of patients who attained HbA_1c levels below 7.0% (53 mmol/mol) without hypoglycemia was 31.1% in the mDiabetes group and 17.1% in the pLogbook group (OR 1.82, 95% CI 1.03-3.21, <i>P</i> = 0.024). There was no difference in the event numbers of severe hyperglycemia and hypoglycemia between the two groups. The implementation of the mDiabetes for patients with inadequately controlled type 2 diabetes resulted in a significant reduction in HbA_1c levels, with tolerable safety profiles.