Phase 2
N=473
Addressing Basic Needs to Improve Diabetes Outcomes in Medicaid Beneficiaries
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT03940209 ↗Enrolled (actual)
473
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: HbA1c — 8.21; 8.16 HbA1c percentage — p=.855
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Basic needs navigation (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HbA1c |
8.21; 8.16 | .855 |
| SECONDARY Health-related Quality of Life |
36.03; 36.52; 45.14; 45.32 | .71 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Medicaid beneficiary
- Member of Louisiana Healthcare Connections
- Age 18-75 years old
- Diagnosed with type 2 diabetes
- Had a HbA1c test in the 3-4 months prior to baseline assessment
Exclusion Criteria
- HbA1c <7.0 in the 3-4 months prior to baseline assessment
- Enrolled in case management at Louisiana Healthcare Connections in the 3 months prior to baseline assessment
- Are currently pregnant or have only been diagnosed with gestational diabetes at baseline
- Have cognitive or hearing impairments that significantly impede participation in telephone-based survey and intervention protocols.
- Individuals not living independently (e.g., nursing homes, rehab or correctional facilities)
Data sourced from ClinicalTrials.gov (NCT03940209). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.