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NCT04334109

Comparative Effectiveness of Family DSMES and Standard DSMES Among Diverse Populations

Completed NA Last updated 3 August 2025
What this trial tests

NA trial testing Family Diabetes Self-Management Education and Support in Diabetes Mellitus, Type 2 in 550 participants. Completed in 17 September 2024.

Timeline
4 January 2021
Primary endpoint
17 May 2023
17 September 2024

Quick facts

Lead sponsorUniversity of Arkansas
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeother
Enrollment550
Start date4 January 2021
Primary completion17 May 2023
Estimated completion17 September 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Arkansas

Who can join

18 and older, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The investigators will conduct a fully-powered, comparative effectiveness randomized controlled trial that includes up to 600 patients with type 2 diabetes (T2D) and 600 of their family members. Patients with T2D will be randomly assigned to either the Family-DSMES arm or the Standard-DSMES arm, with 300 patients in each arm. In the Family-DSMES arm, one of each patient's family members will take part in the educational sessions (family members defined below). Baseline and follow-up data (immediate post-intervention, 6 months post-intervention, and 12 months post-intervention) will be collected from patients and family members in both study arms. In the Standard-DSMES arm, data will be collected from family members, but they will not participate in educational sessions. In both arms, the investigators will obtain a medical records release to abstract outcomes at 18 months post-intervention.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Effectiveness-implementation trial comparing a family model of diabetes self-management education and support with a standard model.
    Mayberry LS, Felix HC, Hudson J, Curran GM, et al · · 2022 · cited 5× · PMID 36096282 · DOI 10.1016/j.cct.2022.106921
  2. Comparative effectiveness of telehealth-delivered family and standard models of diabetes self-management education and support for persons with type 2 diabetes mellitus.
    Andersen JA, McElfish PA, Selig JP, Li J, et al · · 2026 · PMID 41429275 · DOI 10.1016/j.diabres.2025.113063

Verify or expand the search:

Other recruiting trials for Diabetes Mellitus, Type 2

Currently open trials in the same condition.

Other University of Arkansas trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04334109.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing