Trial results for a study investigating personalized care interventions for Type 2 Diabetes were posted on ClinicalTrials.gov on 2025-12-17, with 512 participants enrolled. The study explored the impact of scalable interventions on personalized goal setting and self-care, observing mean A1C reductions across all study groups, with the attention control group showing a mean change of -1.1%.
Background
Type 2 Diabetes is a chronic condition characterized by high blood sugar levels, often leading to serious health complications if not effectively managed. Older adults with diabetes represent a particularly vulnerable population, experiencing higher rates of cardiovascular and microvascular complications, as well as adverse drug events like hypoglycemia. Current treatment approaches often benefit from personalized strategies that support self-care and goal setting. This trial aimed to evaluate the effectiveness of remote delivery of clinical and socioeconomic risk assessment, telephonic care management, and community resource linkage to improve quality of life for these patients.
Trial design
This completed study, designated as Phase NA, enrolled 512 participants diagnosed with Type 2 Diabetes. The trial investigated the impact of scalable interventions designed to support personalized goal setting and self-care. Interventions included remote delivery of clinical and socioeconomic risk assessment, telephonic care management, and community resource linkage. The study compared three groups: an "Attention Control" group, a "My Diabetes Goal" group focusing on personalized goal setting, and a "My Diabetes Goal + Community Rx" group which added community resource linkage.
Key results
The trial reported several key measurements related to glycemic control and goal documentation:
- Mean Change in Percent of Hemoglobin A1C:
- The "Attention Control" group showed a mean change of -1.1% (Standard Deviation 1.79).
- The "My Diabetes Goal" group showed a mean change of -0.8% (Standard Deviation 2.1).
- The "My Diabetes Goal + Community Rx" group showed a mean change of -0.8% (Standard Deviation 1.5).
- Number of Participants With Documentation of Diabetes Goal at Baseline and Month 12:
- At baseline, 52 participants in the "Attention Control" group, 60 in the "My Diabetes Goal" group, and 43 in the "My Diabetes Goal + Community Rx" group had documented goals.
- After baseline (at Month 12), 43 participants in the "Attention Control" group, 165 in the "My Diabetes Goal" group, and 156 in the "My Diabetes Goal + Community Rx" group had documented goals.
- Personalized A1C Goals:
- For the "My Diabetes Goal" group, mean personalized A1C goals were 6.6% (Standard Deviation 0.9) and 7.1% (Standard Deviation 0.8).
- For the "My Diabetes Goal + Community Rx" group, mean personalized A1C goals were 6.7% (Standard Deviation 0.7).
Key analyses included:
- Mixed Models Analysis for outcomes, yielding p-values of 0.8, 0.3, and 0.5.
- Chi-squared analysis for documented goals at baseline across all three arms, yielding a p-value of 0.2.
- Chi-squared analysis for documented goals after baseline in all three arms, yielding a p-value of 0.001.
- Chi-squared analysis for initial goal at baseline, yielding a p-value of 0.7.
What this means
The results indicate that personalized care interventions, including remote support and community resource linkage, were associated with reductions in mean A1C levels across all study groups in older adults with Type 2 Diabetes. While the attention control group showed the largest mean A1C reduction, the statistical analyses for A1C changes (Mixed Models Analysis) did not yield statistically significant p-values, suggesting no significant difference between the intervention groups and control in this regard. However, the significant p-value of 0.001 from the Chi-squared analysis for documented goals after baseline suggests that the interventions may have significantly impacted the rate of goal documentation among participants. These findings contribute to understanding the potential of personalized, remotely delivered care models in supporting self-management in this vulnerable population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study "My Diabetes, My Community" were posted on 2025-12-17 on clinicaltrials.gov.