Trial results for the TARDIS study, investigating photo elicitation and intervention in Type 2 Diabetes, were posted on ClinicalTrials.gov on 2025-10-08, with a total enrollment of 34 participants.
Background
Veterans with type 2 diabetes (T2D) may become overwhelmed with the self-management behaviors needed to maintain optimal health. They may experience diabetes distress (DD), which is distinct from depression, due to the frequency and amount of these behaviors. Diabetes distress negatively influences a Veteran's engagement in self-management and subsequent glycosylated hemoglobin (HbA1c) levels. Previous interventions aimed at improving T2D self-management and reducing DD have not always tailored information to a Veteran's specific diabetes distress, which may contribute to their ineffectiveness.
Trial design
This completed study, identified as Phase NA, enrolled 34 participants. The trial focused on veterans with conditions including Diabetes Mellitus, Type II, Type 2 Diabetes, Diabetes Distress, and issues related to Self Management. The study explored photo elicitation and an intervention approach to address diabetes distress and self-management in this population.
Key results
The trial results included measurements for Diabetes Distress Scale Score and HbA1c Value across two main aims: Photo Elicitation (Aim 3a) and TARDIS Intervention (Aim 3b).
- For the Diabetes Distress Scale Score in the 'Aim 3a - TARDIS Photo Elicitation' group, the mean score was 1.979 with a Standard Deviation of 0.781.
- For the Diabetes Distress Scale Score in the 'Aim 3b - TARDIS Intervention' group, mean scores were reported as 1.824 with a Standard Deviation of 0.784, and also 1.781 with a Standard Deviation of 0.653.
- Regarding HbA1c Value, the 'Aim 3a - TARDIS Photo Elicitation' group had a mean of 8.464 percent with a Standard Deviation of 2.367.
- The 'Aim 3b - TARDIS Intervention' group reported a mean HbA1c Value of 9.705 percent with a Standard Deviation of 1.508.
- Additionally, the study reported on the completion of interviews and calls: For 'Photo Elicitation (Aim 3a) Semi-Structured Interviews', counts of calls completed were 14, 13, 5, and 3.
- For 'Health Coaching Calls (Aim 3b - TARDIS Intervention)', counts of calls completed were 20, 20, and 19.
What this means
The posted results provide specific mean scores for diabetes distress and HbA1c levels observed in veterans with Type 2 Diabetes participating in the TARDIS study's photo elicitation and intervention approaches. The Diabetes Distress Scale scores ranged from approximately 1.781 to 1.979 across the different aims, while mean HbA1c values were observed at 8.464 percent and 9.705 percent. These figures represent the measured outcomes within the study's framework, offering insight into the levels of diabetes distress and glycemic control among the enrolled veteran population under these investigative conditions.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT06972251, titled "TARDIS - Photo Elicitation and Intervention", were posted on 2025-10-08 on clinicaltrials.gov.