A clinical trial investigating a novel mHealth physical activity intervention for youth with Type 1 Diabetes was terminated on 2025-08-19, having enrolled only 1 participant.
Background
Type 1 Diabetes (T1D) is a chronic autoimmune condition requiring lifelong insulin management. For youth living with T1D, maintaining a healthy lifestyle, including regular physical activity, is crucial for managing blood glucose levels, improving cardiovascular health, and enhancing overall well-being. However, adherence to physical activity recommendations can be challenging due to the complexities of T1D management, such as the need to monitor blood sugar and adjust insulin doses around exercise. Mobile health (mHealth) interventions, utilizing smartphones and text messaging, offer a promising avenue to deliver personalized support and encouragement for physical activity, potentially improving health outcomes in this population.
Trial design
This terminated longitudinal cohort study, identified as NCT06018844, aimed to explore a mHealth intervention for youth with Type 1 Diabetes. The study enrolled 1 participant. The intervention involved participants receiving text messages from the Nudge software and reporting physical activity goals via these messages. The main questions the study aimed to answer included whether the intervention increased text message interaction, if these messages increased moderate to vigorous physical activity (MVPA), and if increased MVPA improved participants' HbA1c levels.
Key results
The trial, NCT06018844, was officially terminated. Only 1 participant was enrolled in the study before its termination. Consequently, no efficacy or safety data related to the mHealth intervention could be collected or analyzed as originally intended by the study's objectives, including its impact on text message interaction, physical activity levels, or HbA1c.
What this means
The early termination of this trial and its minimal enrollment of 1 participant mean that no conclusions can be drawn regarding the effectiveness or safety of the novel mHealth physical activity intervention for youth with Type 1 Diabetes. The study's original goals, which included assessing the impact of the Nudge software on physical activity and HbA1c levels, could not be evaluated. This outcome highlights the challenges that can arise in clinical research, preventing the collection of data necessary to inform patient care or future intervention development in this population.
Source
The information regarding this clinical trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT06018844, titled "Novel mHealth Physical Activity Intervention for Youth With Type 1 Diabetes Mellitus", were posted on 2025-08-19 on clinicaltrials.gov.