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NCT04334109
Comparative Effectiveness of Family DSMES and Standard DSMES Among Diverse Populations
NA trial testing Family Diabetes Self-Management Education and Support in Diabetes Mellitus, Type 2 in 550 participants. Completed in 17 September 2024.
17 May 2023
Quick facts
| Lead sponsor | University of Arkansas |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 550 |
| Start date | 4 January 2021 |
| Primary completion | 17 May 2023 |
| Estimated completion | 17 September 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Family Diabetes Self-Management Education and Support
- Standard Diabetes Self-Management Education and Support
Conditions studied
- Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
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):
-
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 -
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:
- PubMed search for NCT04334109
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University of Arkansas trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04334109 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Arkansas
- Last refreshed: 3 August 2025
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