Accepted for/Published in: JMIR mHealth and uHealth
Date Submitted: Sep 14, 2019
Date Accepted: Jan 24, 2020
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Effect of a Smartphone-based Glucose Monitoring and Feedback System for Type 2 Diabetes Management in Multiple Primary Care Clinic Settings: A Cluster Randomized Controlled Study
ABSTRACT
Background:
Recent evidence of the effectiveness of smartphone-based diabetes management systems is generally based in tertiary hospitals or professional diabetes clinics.
Objective:
To evaluate the clinical efficacy and applicability of a smartphone-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 (nine clinics) and 97 (four clinics) participants with T2DM were assigned to the intervention and control groups, respectively (2:1 allocation). Every month, participants in both groups attended a 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 blood glucose (SMBG) results using the smartphone app in addition to outpatient care. 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 per week. At baseline and 3-month follow-up, both groups had anthropometry and blood test, including hemoglobin A1c (HbA1c), as well as questionnaires about treatment satisfaction and compliance.
Results:
At 3-month follow-up, participants in the intervention group showed significantly more improvement in HbA1c (adjusted mean difference to control [95% confidence interval]: -0.30% [0.50 to -0.11], P =.003) and fasting plasma glucose (-17.29 mg/dL [-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 increased more regarding treatment satisfaction and motivation for medication adherence in the intervention group than in the control group. In the subgroup analysis, the effect on glycemic control was more significant among patients with younger age and higher baseline HbA1c level.
Conclusions:
The smartphone-based glucose monitoring and feedback system was effective on glycemic control when applied in primary clinic settings. This system could be utilized effectively with diverse institutions and patients. Clinical Trial: CRIS, KCT0002554; http://cris.nih.go.kr/cris/search/search_result_st01_en.jsp?seq=8832
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