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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.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Voice recording 4 days a day | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Voice recording 4 times a day | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Voice recording of participants | Daily voice recordings | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at inclusion and after 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre-Yves Benhamou, Pr | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rennes University Hospital | Rennes | France | 35200 | France | ||
| Strasbourg University Hospital |
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|
| 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 |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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