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

Abstract

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.

Keywords: Delivery of health care; Diabetes mellitus; Smartphone.

Fig. 1. Change in glycosylated hemoglobin (HbA1c) and fasting plasma glucose after 12 weeks of intervention. (A, C) Mean values of HbA1c and fasting plasma glucose levels, respectively. (B, D) Individual data of HbA1c and fasting plasma glucose levels, respectively. ^aP<0.001, ^bP<0.01.

Fig. 2. Factors correlated with glycosylated hemoglobin (HbA1c) reduction. Baseline HbA1c and the average number of daily glucometer input showed linear correlation to HbA1c reduction (A, B). HbA1c significantly decreased in the patients whose glucometer input frequency was minimal once a day (C) but did not decrease in the patients whose glucometer input frequency was less than once a day (D). ^aP<0.001.

Fig. 3. Changes in the summary of diabetes self-care activities (SDSCA) score after 12 weeks of intervention. (A) Overall change and (B, C) change in the SDSCA scores according to the average number of daily glucometer inputs (upper tertile vs. lower tertile, respectively). (D, E) Change in the SDSCA scores according to the magnitude of glycosylated hemoglobin reduction (upper tertile vs. lower tertile, respectively). ^aP<0.001, ^bP<0.01, ^cP<0.05.