Trial results for an online intervention study aimed at decreasing stress in diabetes were posted on ClinicalTrials.gov on 2025-10-02, involving 309 participants. Both Mindfulness-based stress reduction (MBSR) and Stress Management Education (SME) interventions demonstrated similar reductions in HbA1c levels.
Background
Type 1 and Type 2 Diabetes are chronic conditions requiring careful management, and stress can significantly impact glucose control. For adults living with uncontrolled diabetes, interventions that help manage stress may offer a pathway to improved health outcomes. This study specifically investigated the effects of online stress reduction programs on glucose control, aiming to provide accessible support for individuals managing their diabetes.
Trial design
This completed study, designated as Phase NA, enrolled 309 participants with conditions including Stress, Diabetes Mellitus, Type 2, and Diabetes Mellitus, Type 1. The trial was a randomized controlled study designed to compare a 6-month Mindfulness-based stress reduction (MBSR) intervention against an active control Stress Management Education (SME) program. Both interventions were delivered online through a live interactive virtual classroom using videoconferencing, by experienced instructors. The primary objective was to determine the effects of these interventions on glucose control in adults with uncontrolled type 1 or type 2 diabetes.
Key results
The trial reported key measurements for the change in HbA1c values from baseline, assessed using A1CNow® Self-Check Hemoglobin A1c (HbA1c) Home Kits:
- Change in HbA1c from Baseline to 6-Months (6MO):
- For the Mindfulness Based Stress Reduction group, the least squares mean HbA1c value was 8.50% at baseline and 8.15% at 6 months, representing a change of -0.35 percentage of glycated hemoglobin.
- For the Stress Management Education group, the least squares mean HbA1c value was 8.60% at baseline and 8.24% at 6 months, representing a change of -0.36 percentage of glycated hemoglobin.
- A Mixed Models Analysis comparing the two groups for this outcome reported a Mean Difference (Net) of -0.01 (95% Confidence Interval: -0.36 to 0.34), with a p-value of 0.96.
- Change in HbA1c from Baseline to 2-Months (2MO):
- For the Mindfulness Based Stress Reduction group, the least squares mean HbA1c value was 8.50% at baseline and 8.27% at 2 months, representing a change of -0.23 percentage of glycated hemoglobin.
- For the Stress Management Education group, the least squares mean HbA1c value was 8.60% at baseline and 8.30% at 2 months, representing a change of -0.30 percentage of glycated hemoglobin.
- A Mixed Models Analysis comparing the two groups for this outcome reported a Mean Difference (Net) of -0.07 (95% Confidence Interval: -0.38 to 0.25), with a p-value of 0.68.
What this means
The results indicate that both online Mindfulness-based stress reduction (MBSR) and Stress Management Education (SME) interventions led to similar, modest reductions in HbA1c levels in adults with uncontrolled type 1 or type 2 diabetes. The statistical analyses showed no significant difference between the two intervention groups in terms of HbA1c change at either the 2-month or 6-month mark. This suggests that both online approaches may offer comparable benefits for improving glucose control in this patient population, providing accessible options for stress management in diabetes care.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04016415, titled "Decreasing Stress in Diabetes", were posted on 2025-10-02 on clinicaltrials.gov.