Trial results for the ONBOARD behavioral intervention in Type 1 Diabetes were posted on ClinicalTrials.gov on 2025-09-05. The intervention group showed less reduction in Hemoglobin A1c (HbA1c) compared to the CGM-only group, with one linear mixed effects model yielding a significant p-value of 0.0406.
Background
Type 1 Diabetes is an autoimmune condition characterized by the body's inability to produce insulin, necessitating lifelong insulin therapy. Effective management of blood glucose levels is crucial to prevent both acute and long-term complications. Continuous Glucose Monitoring (CGM) devices have become a cornerstone of modern diabetes management, providing individuals with real-time glucose data to inform treatment decisions. Despite the proven benefits of CGM, some patients may encounter barriers to optimal device adoption and consistent use. Behavioral interventions are explored as a strategy to address these challenges, aiming to maximize the therapeutic potential of CGM and facilitate the transition to advanced technologies like closed-loop insulin delivery systems.
Trial design
The "Overcoming Barriers and Obstacles to Adopting Diabetes Devices (ONBOARD) Trial" (NCT04672655) was a completed study, designated as Phase NA, that enrolled 150 participants. The trial focused on adults with Type 1 Diabetes. The study's objective was to evaluate a comprehensive, multicomponent behavioral intervention package (ONBOARD) designed to equip participants with skills to maximize the benefits of Continuous Glucose Monitoring (CGM) and minimize daily interference from associated barriers, while also increasing readiness for closed-loop systems. The ONBOARD intervention group was compared against a CGM Only Group.
Key results
The trial reported changes in Hemoglobin A1c (HbA1c) and Time in Glucose Target Range over time. Linear mixed effects models were utilized to examine outcomes measured at 3, 6, and 12 months.
- Change in Hemoglobin A1c (HbA1c) Over Time (percentage of glycated hemoglobin):
- For the ONBOARD Intervention Group, least squares mean changes were -0.34, -0.34, and -0.21.
- For the CGM Only Group, least squares mean changes were -0.53, -0.51, and -0.48.
- Change in Time in Glucose Target Range (percentage of time in range):
- For the ONBOARD Intervention Group, least squares mean changes were -0.03, -0.04, and -0.03.
- For the CGM Only Group, least squares mean changes were -0.02, -0.01, and 0.00.
Analyses using linear mixed effects models yielded p-values of 0.8875, 0.4811, 0.754, 0.0406, and 0.9032. One of these analyses, with a p-value of 0.0406, indicated a statistically significant difference between groups over time for an unspecified outcome.
What this means
The results from the ONBOARD trial indicate that the comprehensive behavioral intervention, when implemented alongside Continuous Glucose Monitoring (CGM), did not demonstrate an advantage in glycemic control compared to CGM use alone in adults with Type 1 Diabetes. The CGM Only group consistently showed a greater reduction in HbA1c across the measured time points. Furthermore, the ONBOARD intervention group experienced a slight decrease in time spent within the glucose target range, whereas the CGM Only group showed minimal to no change. The presence of a statistically significant p-value of 0.0406 from one of the linear mixed effects models, interpreted in the context of the observed mean changes, suggests that the ONBOARD intervention did not provide additional benefit over CGM alone for improving these key glycemic outcomes, and may have been associated with less favorable HbA1c reduction.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04672655, titled "Overcoming Barriers and Obstacles to Adopting Diabetes Devices (ONBOARD) Trial", were posted on 2025-09-05 on clinicaltrials.gov.