Effect of a Mobile Phone–Based Glucose-Monitoring and Feedback System for Type 2 Diabetes Management in Multiple Primary Care Clinic Settings: Cluster Randomized Controlled Trial

Background Recent evidence of the effectiveness of mobile phone–based diabetes management systems is generally based on studies conducted in tertiary hospitals or professional diabetes clinics. Objective This study aimed to evaluate the clinical efficacy and applicability of a mobile phone–based glucose-monitoring and feedback system for the management of type 2 diabetes mellitus (T2DM) in multiple primary care clinic settings. Methods In this multicenter, cluster-randomized controlled, open trial, 13 primary care clinics in Seoul and other large cities in South Korea were voluntarily recruited. Overall, 150 (9 clinics) and 97 (4 clinics) participants with T2DM were assigned to the intervention and control groups, respectively (2:1 allocation). Every month, participants in both groups attended face-to-face physicians’ consultation for the management of diabetes in the clinic. For the intervention group, participants were required to upload their daily self-monitoring of blood glucose (SMBG) results using the mobile phone app in addition to outpatient care for 3 months. The results were automatically transmitted to the main server. Physicians had to check their patients’ SMBG results through an administrator’s website and send a short feedback message at least once a week. At baseline and 3 months, both groups had anthropometry and blood tests, including hemoglobin A1c (HbA1c), and responded to questionnaires about treatment satisfaction and compliance. Results At 3 months, participants in the intervention group showed significantly more improvement in HbA1c (adjusted mean difference to control −0.30%, 95% CI −0.50 to −0.11; P=.003) and fasting plasma glucose (−17.29 mg/dL, 95% CI −29.33 to −5.26; P=.005) than those in the control group. In addition, there was significantly more reduction in blood pressure, and the score regarding treatment satisfaction and motivation for medication adherence increased more in the intervention group than in the control group. In the subgroup analyses, the effect on glycemic control was more significant among younger patients and higher baseline HbA1c levels. Conclusions The mobile phone–based glucose-monitoring and feedback system was effective in glycemic control when applied in primary care clinic settings. This system could be utilized effectively with diverse institutions and patients. Trial Registration Clinical Research Information Service (CRIS) https://tinyurl.com/tgqawbz