Mobile Health Intervention in Patients With Type 2 Diabetes: A Randomized Clinical Trial

IMPORTANCE: Clinical pharmacists and health coaches using mobile health (mHealth) tools, such as telehealth and text messaging, may improve blood glucose levels in African American and Latinx populations with type 2 diabetes. OBJECTIVE: To determine whether clinical pharmacists and health coaches using mHealth tools can improve hemoglobin A(1c) (HbA(1c)) levels. DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial included 221 African American or Latinx patients with type 2 diabetes and elevated HbA(1c) (≥8%) from an academic medical center in Chicago. Adult patients aged 21 to 75 years were enrolled and randomized from March 23, 2017, through January 8, 2020. Patients randomized to the intervention group received mHealth diabetes support for 1 year followed by monitored usual diabetes care during a second year (follow-up duration, 24 months). Those randomized to the waiting list control group received usual diabetes care for 1 year followed by the mHealth diabetes intervention during a second year. INTERVENTIONS: The mHealth diabetes intervention included remote support (eg, review of glucose levels and medication intensification) from clinical pharmacists via a video telehealth platform. Health coach activities (eg, addressing barriers to medication use and assisting pharmacists in medication reconciliation and telehealth) occurred in person at participant homes and via phone calls and text messaging. Usual diabetes care comprised routine health care from patients’ primary care physicians, including medication reconciliation and adjustment. MAIN OUTCOMES AND MEASURES: Outcomes included HbA(1c) (primary outcome), blood pressure, cholesterol, body mass index, health-related quality of life, diabetes distress, diabetes self-efficacy, depressive symptoms, social support, medication-taking behavior, and diabetes self-care measured every 6 months. RESULTS: Among the 221 participants (mean [SD] age, 55.2 [9.5] years; 154 women [69.7%], 148 African American adults [67.0%], and 73 Latinx adults [33.0%]), the baseline mean (SD) HbA(1c) level was 9.23% (1.53%). Over the initial 12 months, HbA(1c) improved by a mean of −0.79 percentage points in the intervention group compared with −0.24 percentage points in the waiting list control group (treatment effect, −0.62; 95% CI, −1.04 to −0.19; P = .005). Over the subsequent 12 months, a significant change in HbA(1c) was observed in the waiting list control group after they received the same intervention (mean change, −0.57 percentage points; P = .002), while the intervention group maintained benefit (mean change, 0.17 percentage points; P = .35). No between-group differences were found in adjusted models for secondary outcomes. CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, HbA(1c) levels improved among African American and Latinx adults with type 2 diabetes. These findings suggest that a clinical pharmacist and health coach–delivered mobile health intervention can improve blood glucose levels in African American and Latinx populations and may help reduce racial and ethnic disparities. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02990299