Diabetes Type 1SMART-T1DNCT06985862
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
A study testing Voice recording 4 times a day in people with Diabetes Type 1, run by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Type 1
- What is being tested?
- Voice recording 4 times a day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 5 sitesFrance
- Study dates
- 3 Sep 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who has signed the SMART-T1D free and informed consent form
- Patient able to speak and read French
Who cannot join
- Mute patient.
- Patient with severe speech problems that may prevent voice recordings from being made.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Angers University Hospital
Angers, Site Principal Investigator, 49100
CERITD (Centre d'Etudes et de Recherches pour l'Intensification du Traitement du Diabète)
Évry, 91058
Grenoble University Hospital
Grenoble, 38043
Rennes University Hospital
Rennes, France, 35200
Strasbourg University Hospital
Strasbourg, France, 67091
About this study
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
- Being tested
- Voice recording 4 times a day
- Keywords
- stress, voice markers, glycemic control
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voice recording 4 times a dayOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Voice recording 4 times a day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voice recording of participants
Daily voice recordings
Measured: 14 days
Secondary outcomes (1)
Diabetes-related distress in the test population
DDS T1 is an indicator of overall diabetes distress (average of 17 items, rated 1 to 6 on a scale).
A higher score indicates higher distress.
Measured: at inclusion and after 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start3 Sep 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-Yves Benhamou, Pr, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06985862
- Sponsor's protocol ID
- 2024-A02431-46
- Acronym
- SMART-T1D
- Status last verified
- May 2026
- First submitted
- 31 Mar 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06985862
- Acronym / sponsor ID
- SMART-T1D / 2024-A02431-46
- Conditions
- Diabetes Type 1
- Keywords
- stress, voice markers, glycemic control
- Study type
- Interventional
- Recruitment status
- SuspendedReason 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.
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Centre d'Etudes et de Recherche pour l'Intensification du Traitement du DiabèteUniversity, hospital or other
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Voice recording 4 days a day | Experimental | Other: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient who has signed the SMART-T1D free and informed consent form
- Patient able to speak and read French
Key exclusion criteria (2 listed)
- Mute patient.
- Patient with severe speech problems that may prevent voice recordings from being made.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Voice recording 4 days a day |
Primary outcome
Voice recording of participants
Time frame: 14 days
Daily voice recordings
1 secondary outcome
Diabetes-related distress in the test population
Time frame: at inclusion and after 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre-Yves Benhamou, Pr principal investigator
University Hospital, Grenoble
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Voice recording 4 times a day in people with Diabetes Type 1, run by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Voice recording of participants (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.