mHealth Social Support Versus Standard Support for Diabetes Management in Safety-Net Emergency Department Patients: Randomized Phase-III Trial.

Background: Mobile health (mHealth) is a low-cost method to improve health for patients with diabetes seeking care in safety-net emergency departments, resulting in improved medication adherence and self-management. Additions of social support to mHealth interventions could further enhance diabetes self-management by increasing the gains and the postintervention maintenance.

Objective: We assessed outcomes of an unblinded, parallel, equal-allocation randomized phase-III trial that tested a social support mHealth intervention to improve emergency department patients' diabetes self-management.

Methods: Patients with glycated hemoglobin (HbA_1c) levels of ≥8.5% mg/dL and a text-capable phone were recruited during their emergency department visit for any reason (diabetes related or not) at a US public hospital along with a friend or family member as a supporter. Patients received 6 months of the Trial to Examine Text Messaging in Emergency Department Patients With Diabetes self-management mHealth program. Supporters were randomized to receive either (1) an mHealth social support program (Family and Friends Network Support)-daily SMS text messages guiding supporters to provide diabetes-related social support-or (2) a non-mHealth social support program as an active control-pamphlet-augmented social support with Family and Friends Network Support content. Point-of-care HbA_1c level, self-reported diabetes self-care activities, medication adherence, and safety events were collected. Mixed-effects linear regression models analyzed group differences at the end of the intervention (6 months) and the postintervention phase (12 months) for HbA_1c level and behavioral outcomes.

Results: A total of 166 patients were randomized. In total, 8.4% (n=14) reported type 1 diabetes, 66.9% (n=111) reported type 2 diabetes, and 24.7% (n=41) did not know their diabetes type; 50% (n=83) reported using insulin for diabetes management. Trial follow-up was completed with 58.4% (n=97) of the patients at 6 months and 63.9% (n=106) of the patients at 12 months. Both groups showed significant HbA_1c level improvements (combined group change=1.36%, SD 2.42% mg/dL; 95% CI 0.87-1.83; P<.001), with no group difference (group mean difference=0.14%, SD 4.88% mg/dL; 95% CI -1.11 to 0.83; P=.87) at 6 months. At 12 months, both groups maintained their improved HbA_1c levels, with a combined mean change from 6 months of 0.06% (SD 1.89% mg/dL; 95% CI -0.34 to 0.47; P=.76) and no clinically meaningful difference between groups. No differences were observed in safety events. In subgroup analyses, patients recently diagnosed with diabetes in the mHealth social support group improved their glycemic control compared to the standard social support group (between-group difference of 1.96%, SD 9.59% mg/dL; 95% CI -3.81 to -0.125; P=.04).

Conclusions: A 6-month change in HbA_1c level did not differ by mode of social support in persons using an existing patient-focused mHealth diabetes self-management program, but both groups improved in self-management and glycemic control. Newly diagnosed patients with diabetes benefited most from mHealth-augmented social support.

Trial registration: ClinicalTrials.gov NCT03178773; https://clinicaltrials.gov/study/NCT03178773.

International registered report identifier (irrid): RR2-10.1016/j.cct.2019.03.003.