Digital Health and Community Health Worker Support for Diabetes Management: a Randomized Controlled Trial.

OBJECTIVE: The aim of this study was to evaluate the effectiveness of a digital health intervention plus community health worker (CHW) support on self-monitoring of blood glucose and glycosylated hemoglobin (HbA1c) among adult Medicaid beneficiaries with diabetes. DESIGN: Randomized controlled trial. SETTING: Urban outpatient clinic. PARTICIPANTS: Adult Medicaid beneficiaries living with diabetes and treated with insulin and who had a HbA1c ≥ 9%. INTERVENTION: Participants were randomly assigned to one of three arms. Participants in the usual-care arm received a wireless glucometer if needed. Those in the digital arm received a lottery incentive for daily glucose monitoring. Those in the hybrid arm received the lottery plus support from a CHW if they had low adherence or high blood glucose levels. MAIN MEASURES: The primary outcome was the difference in adherence to daily glucose self-monitoring at 3 months between the hybrid and usual-care arms. The secondary outcome was difference in HbA1c from baseline at 6 months. KEY RESULTS: A total of 150 participants were enrolled in the study. A total of 102 participants (68%) completed the study. At 3 months, glucose self-monitoring rates in the hybrid versus usual-care arms were 0.72 vs 0.65, p = 0.23. At 6 months, change in HbA1c in the hybrid versus usual-care arms was - 0.74% vs - 0.49%, p = 0.69. CONCLUSION: There were no statistically significant differences between the hybrid and usual care in glucose self-monitoring adherence or improvements in HbA1C. TRIAL REGISTRATION: This trial is registered with clinicaltrials.gov identifier: NCT03939793.

Design of a randomized controlled trial of digital health and community health worker support for diabetes management among low-income patients.

BACKGROUND: Insulin-dependent diabetes is a challenging disease to manage and involves complex behaviors, such as self-monitoring of blood glucose. This can be especially challenging in the face of socioeconomic barriers and in the wake of the COVID-19 pandemic. Digital health self-monitoring interventions and community health worker support are promising and complementary best practices for improving diabetes-related health behaviors and outcomes. Yet, these strategies have not been tested in combination. This protocol paper describes the rationale and design of a trial that measures the combined effect of digital health and community health worker support on glucose self-monitoring and glycosylated hemoglobin. METHODS: The study population was uninsured or publicly insured; lived in high-poverty, urban neighborhoods; and had poorly controlled diabetes mellitus with insulin dependence. The study consisted of three arms: usual diabetes care; digital health self-monitoring; or combined digital health and community health worker support. The primary outcome was adherence to blood glucose self-monitoring. The exploratory outcome was change in glycosylated hemoglobin. CONCLUSION: The design of this trial was grounded in social justice and community engagement. The study protocols were designed in collaboration with frontline community health workers, the study aim was explicit about furthering knowledge useful for advancing health equity, and the population was focused on low-income people. This trial will advance knowledge of whether combining digital health and community health worker interventions can improve glucose self-monitoring and diabetes-related outcomes in a high-risk population.