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

NCT06985862 | Suspended

• 1 other identifier: 2024-A02431-46
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 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.

Conditions

Diabetes Type 1

Keywords

stress; voice markers; glycemic control

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.

Other: Voice recording 4 times a day

Interventions

Voice recording 4 times a day OTHER

* 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.

Voice recording 4 days a day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète: lead

Study Sites (5)

Rennes University Hospital

Rennes, France, 35200, France

Location

Strasbourg University Hospital

Strasbourg, France, 67091, France

Location

Angers University Hospital

Angers, Site Principal Investigator, 49100, France

Location

CERITD (Centre d'Etudes et de Recherches pour l'Intensification du Traitement du Diabète)

Évry, 91058, France

Location

Grenoble University Hospital

Grenoble, 38043, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Pierre-Yves Benhamou, Pr

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

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 (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)