The Impact of Digital Self-Monitoring of Weight on Improving Diabetes Clinical Outcomes: Quasi-Randomized Study.

BACKGROUND: The management of type 2 diabetes (T2D) and obesity, particularly in the context of self-monitoring, remains a critical challenge in health care. As nearly 80% to 90% of patients with T2D have overweight or obesity, there is a compelling need for interventions that can effectively manage both conditions simultaneously. One of the goals in managing chronic conditions is to increase awareness and generate behavioral change to improve outcomes in diabetes and related comorbidities, such as overweight or obesity. There is a lack of real-life evidence to test the impact of self-monitoring of weight on glycemic outcomes and its underlying mechanisms. OBJECTIVE: This study aims to assess the efficacy of digital self-monitoring of weight on blood glucose (BG) levels during diabetes management, investigating whether the weight changes may drive glucose fluctuations. METHODS: In this retrospective, real-world quasi-randomized study, 50% of the individuals who regularly used the weight monitoring (WM) feature were propensity score matched with 50% of the users who did not use the weight monitoring feature (NWM) based on demographic and clinical characteristics. All the patients were diagnosed with T2D and tracked their BG levels. We analyzed monthly aggregated data 6 months before and after starting their weight monitoring. A piecewise mixed model was used for analyzing the time trajectories of BG and weight as well as exploring the disaggregation effect of between- and within-patient lagged effects of weight on BG. RESULTS: The WM group exhibited a significant reduction in BG levels post intervention (P<.001), whereas the nonmonitoring group showed no significant changes (P=.59), and both groups showed no differences in BG pattern before the intervention (P=.59). Furthermore, the WM group achieved a meaningful decrease in BMI (P<.001). Finally, both within-patient (P<.001) and between-patient (P=.008) weight variability was positively associated with BG levels. However, 1-month lagged back BMI was not associated with BG levels (P=.36). CONCLUSIONS: This study highlights the substantial benefits of self-monitoring of weight in managing BG levels in patients with diabetes, facilitated by a digital health platform, and advocates for the integration of digital self-monitoring tools in chronic disease management. We also provide initial evidence of testing the underlying mechanisms associated with BG management, underscoring the potential role of patient empowerment.

Association of Digital Engagement With Relaxation Tools and Stress Level Reduction: Retrospective Cohort Study.

BACKGROUND: Stress is an emotional response caused by external triggers and is a high-prevalence global problem affecting mental and physical health. Several different digital therapeutic solutions are effective for stress management. However, there is limited understanding of the association between relaxation components and stress levels when using a digital app. OBJECTIVE: This study investigated the contribution of relaxation tools to stress levels over time. We hypothesized that participation in breathing exercises and cognitive behavioral therapy-based video sessions would be associated with a reduction in stress levels. We also hypothesized a significant reduction specifically in participants' perceived sense of burden and lack of productivity when engaged with breathing exercises and video sessions. METHODS: Stress levels were evaluated in a real-world data cohort using a behavioral health app for digital intervention and monitoring change. This retrospective real-world analysis of users on a mobile platform-based treatment followed users (N=490) who started with moderate and above levels of stress and completed at least 2 stress assessments. The levels of stress were tracked throughout the first 10 weeks. A piecewise mixed effects model was applied to model the trajectories of weekly stress mean scores in 2 time segments (1-6 weeks and 6-10 weeks). Next, a simple slope analysis was used for interpreting interactions probing the moderators: breathing exercises and video sessions. Piecewise mixed-effects models were also used to model the trajectories of specific perceived stress item rates in the stress questionnaire in the 2 segments (1-6 weeks and 6-10 weeks) and whether they are moderated by the relaxation engagements. Simple slope analysis was also used here for the interpretation of the interactions. RESULTS: Analysis revealed a significant decrease in stress symptoms (ß=-.25; 95% CI -0.32 to -0.17; P<.001) during the period of 1-6 weeks of app use that was maintained during the period of 6-10 weeks. Breathing exercises significantly moderated the reduction in stress symptoms during the period of 1-6 weeks (ß=-.07; 95% CI -0.13 to -0.01; P=.03), while engagement in digital video sessions did not moderate stress scores. Engagement in digital video sessions, as well as breathing exercises, significantly moderated the reduction in perceived sense of burden and lack of productivity during weeks 1-6 and remained stable during weeks 6-10 on both items. CONCLUSIONS: This study sheds light on the association between stress level reduction and specific components of engagement in a digital health app, breathing exercises, and cognitive behavioral therapy-based video sessions. Our findings provide a basis for further investigation of current and moderating factors that contribute to the personalization of digital intervention. In addition, results may aid in developing a more comprehensive understanding of how digital intervention tools work for mental health and for whom they are most effective.

Specifying the Efficacy of Digital Therapeutic Tools for Depression and Anxiety: Retrospective, 2-Cohort, Real-World Analysis.

BACKGROUND: Depression and anxiety are the main sources of work and social disabilities as well as health-related problems around the world. Digital therapeutic solutions using cognitive behavioral therapy have demonstrated efficacy in depression and anxiety. A common goal of digital health apps is to increase user digital engagement to improve outcomes. However, there is a limited understanding of the association between digital platform components and clinical outcomes. OBJECTIVE: The aim of the study is to investigate the contribution of specific digital engagement tools to mental health conditions. We hypothesized that participation in coaching sessions and breathing exercises would be associated with a reduction in depression and anxiety. METHODS: Depression and general anxiety symptoms were evaluated in real-world data cohorts using the digital health platform for digital intervention and monitoring change. This retrospective real-world analysis of users on a mobile platform-based treatment followed two cohorts of people: (1) users who started with moderate levels of depression and completed at least 2 depression assessments (n=519) and (2) users who started with moderate levels of anxiety and completed at least 2 anxiety assessments (n=474). Levels of depression (Patient Health Questionnaire-9) and anxiety (Generalized Anxiety Disorder-7) were tracked throughout the first 16 weeks. A piecewise mixed-effects model was applied to model the trajectories of the Patient Health Questionnaire-9 and the Generalized Anxiety Disorder-7 mean scores in 2 segments (1-6 weeks and 7-16 weeks). Finally, simple slope analysis was used for the interpretation of the interactions probing the moderators: coaching sessions and breathing exercises in both depression and anxiety cohorts. RESULTS: Analysis revealed a significant decrease in depression symptoms (ß=-.37, 95% CI -0.46 to 0.28; P≤.001) during the period of weeks 1-6 of app use, which was maintained during the period of 7-16 weeks. Coach interaction significantly moderated the reduction in depression symptoms during the period of weeks 1-6 (ß=-.03, 95% CI -0.05 to -0.001; P=.02). A significant decrease in anxiety symptoms (ß=-.41, 95% CI -0.50 to -0.33; P≤.001) was revealed during the period of 1-6 weeks, which was maintained during the period of 7-16 weeks. Breathing exercises significantly moderated the reduction in anxiety symptoms during the period of 1-6 weeks (ß=-.07, 95% CI -0.14 to -0.01; P=.04). CONCLUSIONS: This study demonstrated general improvement followed by a period of stability of depression and anxiety symptoms associated with cognitive behavioral therapy-based digital intervention. Interestingly, engagement with a coaching session but not a breathing exercise was associated with a reduction in depression symptoms. Moreover, breathing exercise but not engagement with a coaching session was associated with a reduction of anxiety symptoms. These findings emphasize the importance of using a personalized approach to behavioral health during digital health interventions.

Blood Pressure Monitoring as a Digital Health Tool for Improving Diabetes Clinical Outcomes: Retrospective Real-world Study.

BACKGROUND: Remote data capture for blood glucose (BG) or blood pressure (BP) monitoring and the use of a supportive digital app are becoming the model in diabetes and hypertension chronic care. One of the goals in chronic condition management is to increase awareness and generate behavioral change in order to improve outcomes in diabetes and related comorbidities, such as hypertension. In addition, there is a lack of understanding of the association between BG and BP levels when using digital health tools. OBJECTIVE: By applying a rigorous study framework to digital health data, this study investigated the relationship between BP monitoring and BG and BP levels, as well as a lagged association between BP and BG. We hypothesized that during the first 6 months of BP monitoring, BG and BP levels would decrease. Finally, we suggested a positive association between BP levels and the following month's BG levels. METHODS: In this retrospective, real-world case-control study, we extracted the data of 269 people with type 2 diabetes (T2D) who tracked their BG levels using the Dario digital platform for a chronic condition. We analyzed the digital data of the users who, in addition to BG, monitored their BP using the same app (BP-monitoring [BPM] group, n=137) 6 months before and after starting their BP monitoring. Propensity score matching established a control group, no blood pressure monitoring (NBPM, n=132), matched on demographic and baseline clinical measures to the BPM group. A piecewise mixed model was used for analyzing the time trajectories of BG, BP, and their lagged association. RESULTS: Analysis revealed a significant difference in BG time trajectories associated with BP monitoring in BPM and NBPM groups (t=-2.12, P=.03). The BPM group demonstrated BG reduction improvement in the monthly average BG levels during the first 6 months (t=-3.57, P<.001), while BG did not change for the NBPM group (t=0.39, P=.70). Both groups showed similarly stable BG time trajectories (B=0.98, t=1.16, P=.25) before starting the use of the BP-monitoring system. In addition, the BPM group showed a significant reduction in systolic (t=-6.42, P<.001) and diastolic (t=-4.80, P<.001) BP during the first 6 months of BP monitoring. Finally, BG levels were positively associated with systolic (B=0.24, t=2.77, P=.001) and diastolic (B=0.30, t=2.41, P=.02) BP. CONCLUSIONS: The results of this study shed light on the association between BG and BP levels and on the role of BP self-monitoring in diabetes management. Our findings also underscore the need and provide a basis for a comprehensive approach to understanding the mechanism of BP regulation associated with BG.