---
title: 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
overall_status: SUSPENDED
phase: NA
sponsor: "Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète"
study_type: INTERVENTIONAL
primary_condition: Diabetes Type 1
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06985862.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06985862"
ct_last_update_post_date: 2026-05-08
last_seen_at: "2026-05-12T06:14:15.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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](https://clinicaltrials.gov/study/NCT06985862)

## Key Facts

- **Status:** SUSPENDED
- **Why 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.
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 35
- **Lead Sponsor:** Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
- **Conditions:** Diabetes Type 1
- **Start Date:** 2025-09-03
- **Completion Date:** 2026-12
- **CT.gov Last Update:** 2026-05-08

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **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

- **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.

## Primary Outcomes

- **Voice recording of participants** _(time frame: 14 days)_ — Daily voice recordings

## Secondary Outcomes

- **Diabetes-related distress in the test population** _(time frame: at inclusion and after 14 days)_

## Locations (5)

- Rennes University Hospital, Rennes, France, France
- Strasbourg University Hospital, Strasbourg, France, France
- Angers University Hospital, Angers, Site Principal Investigator, France
- CERITD (Centre d'Etudes et de Recherches pour l'Intensification du Traitement du Diabète), Évry, France
- Grenoble University Hospital, Grenoble, France

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.rennes university hospital|rennes|france|france` — added _(2026-05-12)_
- `locations.strasbourg university hospital|strasbourg|france|france` — added _(2026-05-12)_
- `locations.angers university hospital|angers|site principal investigator|france` — added _(2026-05-12)_
- `locations.ceritd (centre d'etudes et de recherches pour l'intensification du traitement du diabète)|évry||france` — added _(2026-05-12)_
- `locations.grenoble university hospital|grenoble||france` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT06985862*  
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