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
SMART-T1D
1 other identifier
interventional
35
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2025
Shorter than P25 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2025
CompletedFirst Posted
Study publicly available on registry
May 22, 2025
CompletedStudy Start
First participant enrolled
September 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2026
CompletedFebruary 18, 2026
September 1, 2025
5 months
March 31, 2025
February 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Voice recording of participants
Daily voice recordings
14 days
Secondary Outcomes (1)
Diabetes-related distress in the test population
at inclusion and after 14 days
Study Arms (1)
Voice recording 4 days a day
EXPERIMENTAL* Morning (first recording): Text reading (article 25.1 of the Declaration of Human Rights). * Noon (second recording): Counting from 1 to 20 at normal speed * Evening (third recording): Prolonged phonation of the vowel 'a' without catching your breath. * Bedtime (fourth recording): Free expression describing stressful moments of the day and their impact on diabetes management, for at least 30 seconds.
Interventions
* Morning (first recording): Text reading (article 25.1 of the Declaration of Human Rights). * Noon (second recording): Counting from 1 to 20 at normal speed * Evening (third recording): Prolonged phonation of the vowel 'a' without catching your breath. * Bedtime (fourth recording): Free expression describing stressful moments of the day and their impact on diabetes management, for at least 30 seconds.
Eligibility Criteria
You may qualify if:
- Patient who has signed the SMART-T1D free and informed consent form
- Patient able to speak and read French
You may not qualify if:
- Mute patient.
- Patient with severe speech problems that may prevent voice recordings from being made.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Rennes University Hospital
Rennes, France, 35200, France
Strasbourg University Hospital
Strasbourg, France, 67091, France
Angers University Hospital
Angers, Site Principal Investigator, 49100, France
CERITD (Centre d'Etudes et de Recherches pour l'Intensification du Traitement du Diabète)
Évry, 91058, France
Grenoble University Hospital
Grenoble, 38043, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre-Yves Benhamou, Pr
University Hospital, Grenoble
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2025
First Posted
May 22, 2025
Study Start
September 3, 2025
Primary Completion
February 1, 2026
Study Completion
February 1, 2026
Last Updated
February 18, 2026
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share