Abstract

BackgroundBy 2034, the number of US individuals with diabetes is predicted to increase from 23.7 to 44.1 million, and annual diabetes-related spending is expected to grow from $113 to $336 billion. Up to 55% of US Hispanics born in the year 2000 are expected to develop diabetes during their lifetime. Poor healthcare access and cultural barriers prevent optimal care, adherence, and clinical benefit, placing Hispanics at disproportionate risk for costly diabetes complications. Mobile technology is increasingly prevalent in all populations and can circumvent such barriers. Our group developed Dulce Digital, an educational text messaging program that improved glycemic control relative to usual care. Dulce Digital-Me (DD-Me) has been tailored to a participant’s individual needs with a greater focus on health behavior change.MethodsThis is a three-arm, parallel group, randomized trial with equal allocation ratio enrolling Hispanic adults with low income and poorly managed type 2 diabetes (N = 414) from a San Diego County Federally Qualified Health Center. Participants are randomized to receive Dulce Digital, Dulce Digital-Me-Automated, or Dulce Digital-Me-Telephonic. The DD-Me groups include Dulce Digital components plus personalized goal-setting and feedback delivered via algorithm-driven automated text messaging (DD-Me-Automated) or by the care team health coach (DD-Me-Telephonic) over a 12-month follow-up period. The study will examine the comparative effectiveness of the three groups in improving diabetes clinical control [HbA1c, primary outcome; low-density lipoprotein cholesterol (LDL-C), and systolic blood pressure (SBP)] and patient-provider communication and patient adherence (i.e., medication, self-management tasks) over 12 months and will examine cost-effectiveness of the three interventions.DiscussionOur comparative evaluation of three mHealth approaches will elucidate how technology can be integrated most effectively and efficiently within primary care-based chronic care model approaches to reduce diabetes disparities in Hispanics and will assess two modes of personalized messaging delivery (i.e., automated messaging vs. telephonic by health coach) to inform cost and acceptability.Trial registrationNCT03130699-All items from the WHO Trial Registration data set are available in https://clinicaltrials.gov/ct2/show/study/NCT03130699.

Highlights

  • By 2034, the number of United States (US) individuals with diabetes is predicted to increase from 23.7 to 44.1 million, and annual diabetes-related spending is expected to grow from $113 to $336 billion

  • In addition to greater prevalence, Hispanics exhibit poorer clinical management and outcomes once diagnosed with type 2 diabetes (T2D) compared to nonHispanic whites [15,16,17]

  • Maintaining good risk factor control reduces the risk of micro- and macrovascular diabetes complications [18,19,20,21], and lowers short- and long-term medical costs [22, 23]

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Summary

Introduction

By 2034, the number of US individuals with diabetes is predicted to increase from 23.7 to 44.1 million, and annual diabetes-related spending is expected to grow from $113 to $336 billion. In the USA, care for people with diagnosed diabetes accounts for one in four health care dollars with an estimated total economic cost of $327 billion in 2017—26% higher than the previous estimate in 2012 [7]. Prevalence of diagnosed diabetes is substantially higher among people of Hispanic ethnicity (12.5%) compared to non-Hispanic whites (7.5%) [11,12,13,14]. In addition to greater prevalence, Hispanics exhibit poorer clinical management and outcomes once diagnosed with type 2 diabetes (T2D) compared to nonHispanic whites [15,16,17]. Risk factor control was poorer in Hispanics compared with non-Hispanic whites [15, 25], a finding consistent with substantial prior research [15]. Many primary care physicians—especially those who care for medically under-resourced populations—are challenged to meet these goals, as clinical endpoints can be affected by social determinants and behavioral factors unrelated to the treatment provided [26]

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