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Accepted for/Published in: JMIR Diabetes

Date Submitted: Jan 30, 2024
Date Accepted: Dec 16, 2024

The final, peer-reviewed published version of this preprint can be found here:

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

Burner E, Hazime D, Menchine M, Mack W, Mercado J, Aleman A, Hernandez Saenz A, Arora S, Wu S

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

JMIR Diabetes 2025;10:e56934

DOI: 10.2196/56934

PMID: 40266665

PMCID: 12059508

Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.

Outcomes of TExT-MED+FANS: a Phase III Randomized Unblinded Trial of mHealth Augmented Social Support vs Standard Social Support in Combination with a mHealth Curriculum for Safety-Net ED Patients with Diabetes

  • Elizabeth Burner; 
  • Danielle Hazime; 
  • Michael Menchine; 
  • Wendy Mack; 
  • Janisse Mercado; 
  • Adriana Aleman; 
  • Antonio Hernandez Saenz; 
  • Sanjay Arora; 
  • Shinyi Wu

ABSTRACT

Background:

: Mobile health (mHealth) is a low-cost method to improve health for patients with diabetes seeking care in safety-net emergency departments (EDs). Additions of social support to mHealth interventions could further enhance diabetes self-management.

Objective:

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

Methods:

Patients with A1C≥8.5%mg/dL and a text-capable phone were recruited during their ED visit. They received 6 months of the TExT-MED diabetes self-management mHealth program. Supporters were randomized to receive either 1) Family and Friends Network Support (FANS) intervention: daily text messages guiding supporters to provide diabetes-related social support or 2) an active control: pamphlet-augmented social support with FANS content. A1C, self-reported diabetes self-care activities, medication adherence, and safety events were measured. Mixed effects linear regression models analyzed group differences at the end of the intervention (6 months) and post intervention phase (12 months).

Results:

166 patients were randomized, with 97 (58%) followed at 6 months and 106 (64%) at 12 months. Both intervention groups showed significant A1C improvements (combined group change 1.36%mg/dl, (95% CI 0.87 to 1.83)), with no group difference (group mean difference = 0.14%mg/dl (95% CI 0.83 to -1.11)). No differences were observed in safety events.

Conclusions:

Six-month change in A1C did not differ by mode of social support in persons using an existing patient-focused mHealth diabetes self-management program. Newly diagnosed diabetes patients benefiting most from mHealth augmented social support. Clinical Trial: ClinicalTrials.gov (NCT03178773)


 Citation

Please cite as:

Burner E, Hazime D, Menchine M, Mack W, Mercado J, Aleman A, Hernandez Saenz A, Arora S, Wu S

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

JMIR Diabetes 2025;10:e56934

DOI: 10.2196/56934

PMID: 40266665

PMCID: 12059508

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