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

NCT ID: NCT06985862

Last Updated: 2025-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-03

Study Completion Date

2026-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Type 1

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Voice recording 4 days a day

* 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.

Group Type EXPERIMENTAL

Voice recording 4 times a day

Intervention Type 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.

Interventions

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Voice recording 4 times a day

* 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient who has signed the SMART-T1D free and informed consent form
* Patient able to speak and read French

Exclusion Criteria

* Mute patient.
* Patient with severe speech problems that may prevent voice recordings from being made.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre-Yves Benhamou, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

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

Évry, , France

Site Status RECRUITING

Grenoble University Hospital

Grenoble, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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France Pasturel

Role: CONTACT

+331 81 85 01 27

Sylvia Franc, MD

Role: CONTACT

+33161697072

Facility Contacts

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Sylvia Franc, MD

Role: primary

+33161697072

Pierre-Yves Benhamou, Pr

Role: primary

+33 4 76765509

Other Identifiers

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2024-A02431-46

Identifier Type: -

Identifier Source: org_study_id

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