Clinical Trial

Development of Artificial Intelligence Tools for the Detection of Stress Markers and Consideration of Stress States in the Monitoring of Subjects With Type 1 Diabetes

Study acronym: SMART-T1D
Suspended
View on ClinicalTrials.gov →
Why the trial stopped
The sponsor has temporarily suspended participant enrollment due to operational constraints impacting study implementation. This decision is not related to safety concerns. The study is expected to resume once the identified issues are addressed.
Summary
Stress refers to all the reactions of an organism subjected to exogenous or endogenous stress. In the context of diabetes, stress plays a critical role. There are two forms of stress: acute and chronic, both of which can have a significant impact on patients' glycaemic control. Acute stress, if repeated, can cause rapid increases in blood glucose levels, while chronic stress can lead to insulin resistance. It is therefore essential to develop tools for recognising and quantifying stress states specific to patients with diabetes. These tools would provide a better understanding of the role of stress in diabetes management, paving the way for more targeted therapeutic interventions and improving patients' quality of life. We are currently training algorithms using advanced machine learning and artificial intelligence techniques to recognise and quantify stress states using existing databases, including voice and physiological data. These technological advances will make it possible to identify moments of stress more accurately and provide appropriate responses, thereby contributing to better diabetes management. The SMART-T1D study is an ancillary study of the EVASTRESS study.
Protocol Amendment History 4 changes
critical Recruitment suspended 2026-05-09
critical Reason stopped changed: — → The sponsor has temporarily suspended participant enrollment due to operational constraints impacting study implementation. This decision is not related to safety concerns. The study is expected to resume once the identified issues are addressed. 2026-05-09
notable Primary completion pushed: 2026-02 -> 2026-12 2026-05-09
minor Completion pushed: 2026-02 -> 2026-12 2026-05-09
Trial Details
NCT Number NCT06985862
Lead Sponsor Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Conditions Diabetes Type 1
Enrollment 35 participants
Start Date 2025-09-03
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-05-08