Results from a pilot randomized controlled trial investigating a nutrition-supported diabetes education program for Type 2 Diabetes were posted on ClinicalTrials.gov on 2025-07-29. The study, which enrolled 36 participants, did not demonstrate significant improvements in glycemic control or food security compared to standard care.
Background
Type 2 Diabetes is a chronic condition requiring ongoing management, often involving lifestyle modifications, dietary changes, and self-management education. For Medicaid-enrolled patients within safety-net health systems, factors like food insecurity can significantly complicate effective diabetes management. Programs that integrate diabetes education with tailored food support aim to address these barriers, potentially improving glycemic control and overall well-being. This pilot trial sought to evaluate the feasibility and preliminary impact of such an integrated approach.
Trial design
This completed study, designated as Phase NA, enrolled 36 participants with Diabetes Mellitus, Type 2. The trial was a pragmatic, pilot randomized controlled trial of the Nutrition-Supported Diabetes Education Program (NU-DSMP). It aimed to test the feasibility and preliminary impact of providing diabetes-tailored food support and individualized case-management on glycemic control and other intermediate outcomes, including food security, diet, mental health, and healthcare behaviors.
Participants were randomized into two arms: one receiving Standard of Care and Diabetes Self-management Education, and the other receiving Diabetes-tailored Food Support Plus Diabetes Self-management Education.
Key results
The trial reported several key measurements over twelve weeks:
- Change in Hemoglobin A1c (HbA1c) From Baseline to Twelve Weeks (Percentage of glycated hemoglobin):
- For the Standard of Care arm, the mean change was -0.023 (Standard Deviation 1.63).
- For the Diabetes-tailored Food Support Plus Diabetes Self-management Education arm, the mean change was 0.131 (Standard Deviation 2.14).
- Change in Food Security Severity From Baseline to Twelve Weeks (score on a scale):
- For the Standard of Care arm, the mean change was -1.31 (Standard Deviation 3.17).
- For the Diabetes-tailored Food Support Plus Diabetes Self-management Education arm, the mean change was 0.067 (Standard Deviation 1.71).
- Change in the Percentage of Participants With Glucose Control From Baseline to Twelve Weeks (Percentage of participants):
- For the Standard of Care arm, the change was 7.70%.
- For the Diabetes-tailored Food Support Plus Diabetes Self-management Education arm, the change was -7.70%.
- Change in the Percentage of Participants With Low and Very Low Food Security From Baseline to Twelve Weeks (Percentage of participants):
- For the Standard of Care arm, the change was -15.4%.
- For the Diabetes-tailored Food Support Plus Diabetes Self-management Education arm, the change was 20%.
- Change in Health-related Quality of Life (Healthy Days) From Baseline to Twelve Weeks (days):
- For the Standard of Care arm, the mean change was -1.38 (Standard Deviation 9.39).
- For the Diabetes-tailored Food Support Plus Diabetes Self-management Education arm, the mean change was 0.800 (Standard Deviation 16.2).
- Change in Consumption of Fruits and Vegetables From Baseline to Twelve Weeks (cup equivalents):
- For the Standard of Care arm, the mean change was 0.294 (Standard Deviation 0.962).
- For the Diabetes-tailored Food Support Plus Diabetes Self-management Education arm, the mean change was 0.317 (Standard Deviation 0.973).
Key analyses indicated no statistically significant differences between the study arms for the measured outcomes:
- For HbA1c, an ANCOVA analysis yielded a p-value of 0.9, with a slope of -0.092 (95.0% CI: -1.59 to 1.4).
- For Food Security Severity, a Mixed Models Analysis yielded a p-value of 0.146, with a slope of 1.37 (95.0% CI: -0.478 to 3.23).
- For the Percentage of Participants With Glucose Control, an ANCOVA analysis yielded a p-value of 0.281, with a Risk Difference (RD) of 0.235 (95.0% CI: -0.207 to 0.677).
- For the Percentage of Participants With Low and Very Low Food Security, a Mixed Models Analysis yielded a p-value of 0.094, with a Risk Difference (RD) of 0.354 (95.0% CI: -0.06 to 0.768).
- For Health-related Quality of Life (Healthy Days), a Mixed Models Analysis yielded a p-value of 0.669, with a slope of 2.18 (95.0% CI: -7.83 to 12.2).
- For Consumption of Fruits and Vegetables, a Mixed Models Analysis yielded a p-value of 0.949, with a slope of -0.024 (95.0% CI: -0.695 to 0.743).
What this means
The pilot trial results indicate that the Nutrition-Supported Diabetes Education Program, as implemented in this study, did not lead to statistically significant improvements in glycemic control, food security severity, or other measured health outcomes over twelve weeks when compared to standard care and diabetes self-management education alone. In some instances, such as the percentage of participants with glucose control and low/very low food security, the intervention arm showed less favorable changes than the control arm. These findings suggest that further investigation or refinement of such programs may be needed to demonstrate a measurable benefit for patients with Type 2 Diabetes.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05067452, titled "Pilot Trial of the Nutrition-Supported Diabetes Education Program", were posted on 2025-07-29 on clinicaltrials.gov.