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NCT03940209
Addressing Basic Needs to Improve Diabetes Outcomes in Medicaid Beneficiaries
Phase 2 trial testing Basic needs navigation in Diabetes Mellitus, Type 2 in 473 participants. Status unknown.
30 June 2024
Quick facts
| Lead sponsor | Washington University School of Medicine |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | supportive care |
| Enrollment | 473 |
| Start date | 1 November 2019 |
| Primary completion | 30 June 2024 |
| Estimated completion | 30 June 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Basic needs navigation
Conditions studied
- Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
Sponsor
Washington University School of Medicine
Who can join
Adults 18 to 75, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This pragmatic randomized trial will test the effectiveness of a basic needs navigation intervention compared to usual care among 500 adults (ages 18-75) with Medicaid, type 2 diabetes, and 1 or more unmet basic needs. Basic needs includes having such things as adequate food, housing, personal safety, and money for necessities. The primary study hypothesis is that participants who receive navigation to address unmet basic needs will have a greater reduction (M=0.5%) in HbA1c pre-post compared with participants receiving usual care. Consistent with the study's conceptual model, the effects of unmet basic needs on barriers to self-care (e.g., attention, stress, sleep), health behaviors (e.g., glucose monitoring, diet, clinical screenings) and health outcomes (e.g., emergency department utilization, hospitalization, quality of life) will be examined.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
A Randomized Controlled Trial Testing the Effects of a Social Needs Navigation Intervention on Health Outcomes and Healthcare Utilization among Medicaid Members with Type 2 Diabetes.
McQueen A, von Nordheim D, Caburnay C, Li L, et al · · 2024 · cited 1× · PMID 39063512 · DOI 10.3390/ijerph21070936 -
Correlates of Self-Reported Executive Function Impairment Among Medicaid Beneficiaries With Type 2 Diabetes.
Von Nordheim D, Herrick C, Verdecias N, Garg R, et al · · 2024 · PMID 39649689 · DOI 10.2337/ds23-0067
Verify or expand the search:
- PubMed search for NCT03940209
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT07242469 — A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006) · Phase 1 · recruiting
- NCT07444203 — Transformative Research in Diabetic Nephropathy 2.0 · recruiting
Other Washington University School of Medicine trials
Trials by the same sponsor.
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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 NCT03940209 (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 Washington University School of Medicine
- Last refreshed: 28 March 2024
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/NCT03940209.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing