Trial results for a study investigating differing completion rates of diabetes education on patient-reported outcomes in Type 2 Diabetes were posted on ClinicalTrials.gov on 2025-09-22, with one group showing a mean decrease of 6.5 in diabetes distress.
Background
Type 2 Diabetes is a chronic condition that often requires comprehensive self-management strategies. Diabetes self-management education (DSME) programs are designed to equip patients with the knowledge and skills needed to manage their condition effectively. However, the impact of varying completion rates of these programs on patient-reported outcomes, such as diabetes distress and quality of life, is an important area of study. Understanding how different levels of engagement with educational programs affect these outcomes can help optimize patient support and improve overall well-being for individuals living with Type 2 Diabetes.
Trial design
This completed study, identified as Phase NA, enrolled 120 participants diagnosed with Diabetes Mellitus, Type 2, and focused on Patient Education as Topic. The trial aimed to test the impact of differing completion rates of a face-to-face diabetes self-management education programme on patient-reported outcomes, including self-care, diabetes distress, and quality of life. Participants were compared across four study groups.
Key results
The trial results detail changes in diabetes distress and quality of life across the four study groups:
- For "Change in Diabetes Distress (Pre and Post Intervention) Using the Problem Areas in Diabetes (PAID) Tool":
- Group 1 showed a mean adjusted change score of 8.14 (Standard Error: 2.44).
- Group 2 showed a mean adjusted change score of 7.14 (Standard Error: 2.53).
- Group 3 showed a mean adjusted change score of 2.54 (Standard Error: 2.52).
- Group 4 showed a mean adjusted change score of -6.5 (Standard Error: 2.48).
- For "• Mental Health Quality of Life Outcome Measures (Pre and Post Intervention) Using the PROMIS-Global Health V1.2 Scale":
- Group 1 showed a mean change score of 3.0 (Standard Deviation: 6.18).
- Group 2 showed a mean change score of 1.07 (Standard Deviation: 4.77).
- Group 3 showed a mean change score of -0.88 (Standard Deviation: 7.67).
- Group 4 showed a mean change score of -0.61 (Standard Deviation: 8.22).
- For "Physical Health Quality of Life Outcome Measures (Pre and Post Intervention) Using the PROMIS-Global Health V1.2 Scale":
- Group 1 showed a mean change score of 2.27 (Standard Deviation: 6.95).
- Group 2 showed a mean change score of 2.58 (Standard Deviation: 4.92).
- Group 3 showed a mean change score of -0.67 (Standard Deviation: 6.56).
- Group 4 showed a mean change score of 0.48 (Standard Deviation: 7.15).
What this means
The results suggest that differing completion rates of diabetes self-management education programs can have varied impacts on patient-reported outcomes for individuals with Type 2 Diabetes. Notably, Group 4 experienced a mean decrease of 6.5 in diabetes distress, indicating an improvement in this area. For mental health quality of life, Group 1 and Group 2 showed slight positive changes, while Group 3 and Group 4 showed slight negative changes. In terms of physical health quality of life, Group 1 and Group 2 also showed positive changes, with Group 3 showing a slight negative change and Group 4 a slight positive change. These findings highlight the complex relationship between educational program engagement and patient well-being, suggesting that the extent of program completion may influence specific aspects of patient experience differently.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT06419907, titled "Differing Completion Rates of DIABETES Education on Patient Reported Outcomes", were posted on 2025-09-22 on clinicaltrials.gov.