Dulce Digital-Me: results of a randomized comparative trial of static versus adaptive digital interventions for Latine adults with diabetes

Objective: To compare the effectiveness of a static, text-based diabetes education and support intervention (Dulce Digital, DD) versus a dynamic approach with personalized feedback and goal setting (Dulce Digital-Me, DD-Me) in improving diabetes outcomes. Design and methods: Comparative effectiveness trial in 310 Latine adults with poorly managed type 2 diabetes in a Federally Qualified Health Center in Southern California, randomized to DD, DD-Me-Auto (algorithm-driven text-based personalized feedback), or DD-Me-Tel (coach delivered personalized feedback). Changes in HbA1c (primary outcome), low-density lipoprotein-cholesterol, systolic blood pressure, and patient-reported outcomes were examined across 6 and 12 months, with the primary comparison being DD versus DD-Me (combined automated and telephonic). Results: Participants were 52.1 (+/- 10.2) years old, 69.7% female, with HbA1c 9.3% (+/- 1.6) at baseline. Across groups, there was a statistically significant improvement in HbA1c at 6 months (mean triangle per month = -0.17, 95% CI -0.20, -0.14; P < .001) and 12 months (mean triangle per month = -0.07, 95% CI -0.09, -0.05; P < .001). However, there were no time-by-group interaction effects indicating group differences in clinical outcomes across 6 or 12 months. The DD-Me groups showed greater improvements across time than the DD group for diabetes self-management behaviors. Conclusions: Static and adaptive digital interventions for Latine adults with type 2 diabetes had similar and clinically significant effects on HbA1c across 12 months. Simple digital approaches can be integrated within primary care-based chronic care models to reduce diabetes disparities. ClinicalTrials.gov registration: NCT03130699, Initial Release 04/24/2017, https://clinicaltrials.gov/ct2/show/NCT03130699?term=NCT03130699&draw=2&rank=1.