Feasibility of a Patient-Centered, Smartphone-Based, Diabetes Care System: A Pilot Study

Background: We developed a patient-centered, smartphone-based, diabetes care system (PSDCS). This study aims to test the feasibility of glycosylated hemoglobin (HbA1c) reduction with the PSDCS. Methods: This study was a single-arm pilot study. The participants with type 2 diabetes mellitus were instructed to use the PSDCS, which integrates a Bluetooth-connected glucometer, digital food diary, and wearable physical activity monitoring device. The primary end point was the change in HbA1c from baseline after a 12-week intervention. Results: Twenty-nine patients aged 53.9+/-9.1 years completed the study. HbA1c and fasting plasma glucose levels decreased significantly from baseline (7.7%+/-0.7% to 7.1%+/-0.6%, P< 0.0001; 140.9+/-39.1 to 120.1+/-31.0 mg/dL, P=0.0088, respectively). The frequency of glucose monitoring correlated with the magnitude of HbA1c reduction (r=-0.57, P=0.0013). The components of the diabetes self-care activities, including diet, exercise, and glucose monitoring, were significantly improved, particularly in the upper tertile of HbA1c reduction. There were no severe adverse events during the intervention. Conclusion: A 12-week application of the PSDCS to patients with inadequately controlled type 2 diabetes resulted in a significant HbA1c reduction with tolerable safety profiles; these findings require confirmation in a future randomized controlled trial.