• Elizabeth M Vaughan, David J Hyman, Aanand D Naik, Susan L Samson, Javad Razjouyan, and John P Foreyt.
• Division of General Internal Medicine, Department of Medicine , Baylor College of Medicine, Houston, TX, USA. elizabeth.vaughan@bcm.edu.
• J Gen Intern Med. 2021 Feb 1; 36 (2): 455463455-463.

BackgroundMany individuals with diabetes live in low- or middle-income settings. Glycemic control is challenging, particularly in resource-limited areas that face numerous healthcare barriers.ObjectiveTo compare HbA1c outcomes for individuals randomized to TIME, a Telehealth-supported, Integrated care with CHWs (Community Health Workers), and MEdication-access program (intervention) versus usual care (wait-list control).DesignRandomized clinical trial.ParticipantsLow-income Latino(a) adults with type 2 diabetes.InterventionsTIME consisted of (1) CHW-participant telehealth communication via mobile health (mHealth) for 12 months, (2) CHW-led monthly group visits for 6 months, and (3) weekly CHW-physician diabetes training and support via telehealth (video conferencing).Main MeasuresInvestigators compared TIME versus control participant baseline to month 6 changes of HbA1c (primary outcome), blood pressure, body mass index (BMI), weight, and adherence to seven American Diabetes Association (ADA) standards of care. CHW assistance in identifying barriers to healthcare in the intervention group were measured at the end of mHealth communication (12 months).Key ResultsA total of 89 individuals participated. TIME individuals compared to control participants had significant HbA1c decreases (9.02 to 7.59% (- 1.43%) vs. 8.71 to 8.26% (- 0.45%), respectively, p = 0.002), blood pressure changes (systolic: - 6.89 mmHg vs. 0.03 mmHg, p = 0.023; diastolic: - 3.36 mmHg vs. 0.2 mmHg, respectively, p = 0.046), and ADA guideline adherence (p < 0.001) from baseline to month 6. At month 6, more TIME than control participants achieved > 0.50% HbA1c reductions (88.57% vs. 43.75%, p < 0.001). BMI and weight changes were not significant between groups. Many (54.6%) TIME participants experienced > 1 barrier to care, of whom 91.7% had medication issues. CHWs identified the majority (87.5%) of barriers.ConclusionsTIME participants resulted in improved outcomes including HbA1c. CHWs are uniquely positioned to identify barriers to care particularly related to medications that may have gone unrecognized otherwise. Larger trials are needed to determine the scalability and sustainability of the intervention.Clinical TrialNCT03394456, accessed at https://clinicaltrials.gov/ct2/show/NCT03394456.

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