Abstract

BackgroundDiabetes is a complex, demanding disease that requires the constant attention of patients. The burden of self-management, including different medication regimens, routine self-care activities, and provider visits, has an impact on patients’ emotional well-being. Diabetes distress and depression are two important components of emotional well-being that may negatively affect diabetes outcomes.ObjectiveThe aim was to determine the impact of the 1-year Mobile Diabetes Intervention Study cluster randomized clinical trial on emotional well-being measured by diabetes distress and depression among adults with type 2 diabetes (T2D).MethodsA total of 163 adults with not-well-managed T2D were enrolled from community primary care practices. Primary care practices were cluster randomized into either a usual care control group or intervention group. Intervention participants were given a mobile phone with coaching software including a Web portal to communicate with providers. A priori established secondary outcomes included distress measured by the Diabetes Distress Scale (DDS), with subscales measuring emotional burden, interpersonal distress, physician-related distress, and regimen-related distress, as well as depression measured by the Patient Health Questionnaire (PHQ-9). Linear mixed models were used to calculate the effect of the intervention on diabetes distress levels over time, both overall and separately by sex, and to determine if the intervention affected distress or depression. The impact of total DDS on changes in HbA1c was also studied.ResultsThere were no significant treatment group effects for DDS total (baseline: P=.07; differences over time: P=.38) or for depression (P=.06 over time). Significant declines in total DDS were observed over the 12-month intervention period (P=.01). Regimen-related distress significantly decreased for all study participants (P<.001), but no significant change over time was observed for emotional burden (P=.83), interpersonal distress (P=.64), or physician-related distress (P=.73). Women in both the usual care and intervention groups were more likely to have higher overall DDS, emotional burden, physician-related distress, and regimen-related distress, but not interpersonal distress. Women also reported higher baseline depression compared to men (P=.006). Overall, depression decreased over the treatment period (P=.007), but remained unaffected by group assignment (P=.06) or by sex (P=.97). Diabetes distress had no effect on the change in HbA1c (P=.91) over the treatment period.ConclusionsAlthough we found no definitive overall or sex-specific effect of the intervention on diabetes distress or depression, this study makes an important contribution to the understanding of mobile health interventions and the impact on emotional health. Our study verified previous work that although diabetes distress and depression are highly correlated, these measures are not evaluating the same construct. Design of future mobile technology provides an opportunity to personalize, contextualize, and intervene in the emotional well-being of persons with diabetes.Trial RegistrationClinicaltrials.gov NCT01107015; https://clinicaltrials.gov/ct2/show/NCT01107015 (Archived by WebCite at http://www.webcitation.org/6vVgRCLAF)

Highlights

  • The National Diabetes Statistics Report, a periodic publication of the Centers for Disease Control and Prevention (CDC), provides information on the prevalence and incidence of diabetes and prediabetes, risk factors for complications, acute and long-term complications, deaths, and costs

  • Estimated percentages and total number of people with diabetes and prediabetes were derived from the National Health and Nutrition Examination Survey (NHANES), National Health Interview Survey (NHIS), Indian Health Service (IHS) National Data Warehouse (NDW), Behavioral Risk Factor Surveillance System (BRFSS), United States Diabetes Surveillance System (USDSS), and US resident population estimates

  • To estimate the number of adults with diagnosed and undiagnosed diabetes, the age, sex, race/ ethnicity-specific percentages from three-way cross-tabulations were applied to the corresponding July 1, 2018 US resident population estimates from the US Census Bureau

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Summary

INTRODUCTION

The National Diabetes Statistics Report, a periodic publication of the Centers for Disease Control and Prevention (CDC), provides information on the prevalence and incidence of diabetes and prediabetes, risk factors for complications, acute and long-term complications, deaths, and costs. These data can help focus efforts to prevent and control diabetes across the United States. This document is an update of the 2017 National Diabetes Statistics Report and is intended for a scientific audience

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