Trial results for a basic needs navigation intervention in Type 2 Diabetes patients were posted on ClinicalTrials.gov on 2026-05-04. The study found no significant difference in HbA1c levels between the intervention and usual care groups, with a p-value of 0.855.
Background
Type 2 Diabetes is a chronic condition characterized by high blood sugar levels. Effective management often requires consistent access to healthcare, healthy food, and a stable living environment. Unmet basic needs, such as inadequate food, housing, personal safety, or financial resources, can significantly impede a patient's ability to manage their diabetes effectively, potentially leading to poorer health outcomes. Interventions addressing these social determinants of health are explored as a way to improve diabetes management.
Trial design
The completed Phase 2 pragmatic randomized trial (NCT03940209) enrolled 473 adults with Type 2 Diabetes who were Medicaid beneficiaries and reported one or more unmet basic needs. The study aimed to test the effectiveness of a basic needs navigation intervention compared to usual care. The primary study hypothesis was that participants receiving navigation to address unmet basic needs would have a greater reduction (mean of 0.5%) in HbA1c pre-post compared with participants receiving usual care.
Key results
For the primary outcome of HbA1c, the mean value in the Usual Care group was 8.21% (Standard Deviation: 1.84), while in the Basic Needs Navigation group, it was 8.16% (Standard Deviation: 1.74). A two-sided t-test comparing these groups yielded a p-value of 0.855, indicating no statistically significant difference in HbA1c levels between the intervention and usual care groups.
Regarding Health-related Quality of Life, one measurement showed a mean of 36.03 (Standard Deviation: 11.84) for Usual Care and 36.52 (Standard Deviation: 11.53) for Basic Needs Navigation. Another measurement reported a mean of 45.14 (Standard Deviation: 8.04) for Usual Care and 45.32 (Standard Deviation: 9.02) for Basic Needs Navigation. Analyses for the 12-month Physical Health aggregate subscale resulted in a p-value of 0.71, and for the 12-month Mental Health aggregate subscale, a p-value of 0.86. These p-values suggest no significant differences in health-related quality of life outcomes between the groups.
What this means
The results suggest that the basic needs navigation intervention, as tested in this trial, did not lead to a statistically significant improvement in HbA1c levels or health-related quality of life for Medicaid beneficiaries with Type 2 Diabetes and unmet basic needs. The lack of a significant difference (p-value of 0.855 for HbA1c) indicates that the intervention did not meet its primary hypothesis of a greater reduction in HbA1c compared to usual care. This outcome may prompt further investigation into the design and implementation of such interventions or the specific populations they target.
Source
The information for this condition update was obtained from ClinicalTrials.gov, a public database of clinical studies. The trial results for NCT03940209, titled "Addressing Basic Needs to Improve Diabetes Outcomes in Medicaid Beneficiaries," were posted on 2026-05-04 on clinicaltrials.gov.