Mobile App for Improved Self-Management of Type 2 Diabetes: Multicenter Pragmatic Randomized Controlled Trial

Abstract

BackgroundAs the increasing prevalence of type 2 diabetes mellitus has put pressure on health systems to appropriately manage these patients, there have been a growing number of mobile apps designed to improve the self-management of diabetes. One such app, BlueStar, has been shown to significantly reduce hemoglobin A1c (HbA1c) levels in small studies and is the first app in the United States to receive Food and Drug Administration approval as a mobile prescription therapy. However, the impact of the app across real-world population among different clinical sites and health systems remains unclear.ObjectiveThe primary objective of this study was to conduct a pragmatic randomized controlled trial of the BlueStar mobile app to determine if app usage leads to improved HbA1c levels among diverse participants in real-life clinical contexts. We hypothesized that this mobile app would improve self-management and HbA1c levels compared with controls.MethodsThe study consisted of a multicenter pragmatic randomized controlled trial. Overall, 110 participants randomized to the immediate treatment group (ITG) received the intervention for 6 months, and 113 participants randomized to the wait-list control (WLC) group received usual care for the first 3 months and then received the intervention for 3 months. The primary outcome was glucose control measured by HbA1c levels at 3 months. Secondary outcomes assessed intervention impact on patient self-management, experience of care, and self-reported health utilization using validated scales, including the Problem Areas in Diabetes, the Summary of Diabetes Self-Care Activities, and the EuroQol-5D. Intervention usage data were collected directly from the app.ResultsThe results of an analysis of covariance controlling for baseline HbA1c levels did not show evidence of intervention impact on HbA1c levels at 3 months (mean difference [ITG−WLC] −0.42, 95% CI −1.05 to 0.21; P=.19). Similarly, there was no intervention effect on secondary outcomes measuring diabetes self-efficacy, quality of life, and health care utilization behaviors. An exploratory analysis of 57 ITG participants investigating the impact of app usage on HbA1c levels showed that each additional day of app use corresponded with a 0.016-point decrease in participants’ 3-month HbA1c levels (95% CI −0.03 to −0.003). App usage varied significantly by site, as participants from 1 site logged in to the app a median of 36 days over 14 weeks (interquartile range [IQR] 10.5-124); those at another site used the app significantly less (median 9; IQR 6-51).ConclusionsThe results showed no difference between intervention and control arms for the primary clinical outcome of glycemic control measured by HbA1c levels. Although there was low usage of the app among participants, results indicate contextual factors, particularly site, had a significant impact on overall usage. Future research into the patient and site-specific factors that increase app utilization are needed.Trial RegistrationClinicaltrials.gov NCT02813343; https://clinicaltr...

Smartphone-Based Technology in Diabetes Management

“…BlueStar is an in-app diabetes coach available for Android and iOS devices. This was the first mobile app in the USA to be given FDA approval as a mobile prescription therapy [30]. In the BlueStar app, patients can enter their blood glucose levels (wirelessly or manually) and receive real-time coaching.…”

“…In a randomized multicenter controlled trial with 110 participants in the immediate treatment group (ITG), who used the app for 6 months, and with 113 in the wait-list control (WLC) group, who received usual care for the first 3 months and then used the app for the last 3 months of the study, HbA1c levels did not show evidence of reduction at 3 months (mean difference [ITG -WLC] -0.42, 95% CI -1.05 to 0.21; p = 0.19). Additionally, no effect was proven on diabetes self-management, quality of life, and healthcare utilization behaviors [30]. Older studies had shown significant HbA1c reduction [32] and improvement in self-efficacy [31].…”

The effectiveness of a mobile phone education-based on self-efficacy and DASH diet among patient with high blood pressure: a randomized controlled trial

“…All recommendations were delivered through smart phone apps. In recent years using mobile apps for improving health-related problems has grown signi cantly [53][54][55]. In essence using these apps for HTN patients also is not an exception.…”

Efficacy and Acceptability of My Care Hub Mobile App to Support Self-Management in Australians with Type 1 or Type 2 Diabetes

“…Few short-term research studies have reported on the preliminary efficacy of mobile phone apps either in relation to overall DSM activities or for single self-management activity change (e.g., dietary or physical activity only). Agarwal et al [50] and Faridi et al [51] tested the effect of a mobile technology on overall DSM, while others have monitored diet [52] or physical activity [52] as part of program evaluation for diabetes support. Preliminary efficacy results of these apps vary from none [50] to moderate [51,52] among participants in the intervention settings.…”

“…Agarwal et al [50] and Faridi et al [51] tested the effect of a mobile technology on overall DSM, while others have monitored diet [52] or physical activity [52] as part of program evaluation for diabetes support. Preliminary efficacy results of these apps vary from none [50] to moderate [51,52] among participants in the intervention settings. Therefore, the significant improvements in DSM observed in our study are unique and they could be termed to have clinical significance when viewed in the context of impact on diabetes management.…”