Status:
RECRUITING
Multicenter Study Evaluating the Relationship Between Perceived Daily Stress Level and Glycemic Level in Subjects With Type 1 Diabetes
Lead Sponsor:
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Conditions:
Diabetes Type 1
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Type 1 diabetes (T1D) affects around 200,000 people in France. The only treatment is insulin, administered either by multiple injections, by pump alone or, more recently, by automated insulin delivery...
Eligibility Criteria
Inclusion
- Patient with a clinical diagnosis of type 1 diabetes of at least 1 year, as determined by the medical record;
- Patient aged at least 18 years;
- Patient treated with an external insulin pump for at least 2 months or with multi-injections;
- Patient with a smartphone compatible with iOS 15.0 or higher or Android 12.0 or higher;
- Patient with a smartphone with Bluetooth 5.0 or higher;
- Patient with HbA1c ≤ 10% with measurement ≤3 months;
- Patient with no psychiatric pathology that could interfere with the study;
- Patient having signed the free and informed consent form to participate in the study;
- Patient affiliated to the French Social Security system;
- Patient agreeing not to eat between meals for the duration of the study (except for hypoglycaemia and/or snacks during physical activity);
- Patient agrees to wear an Empatica EmbracePlus watch for the duration of the study and to charge it according to the device's requirements for recording data;
- Patient agreed to wear an OURA ring for the duration of the study and to recharge it as required by the device to enable data recording (patients at the CERITD centre only).
Exclusion
- Type 2 diabetic patient;
- Patient fitted with a closed loop (or artificial pancreas);
- Patient with any characteristic pathology that could interfere with the study (renal failure, unstabilised diabetic retinopathy, heart failure, heart attack within 6 months prior to inclusion, severe neuropathy, particularly autonomic neuropathy);
- Patients with a tendency to snack;
- Patients undergoing treatment with drugs known to significantly interfere with blood sugar levels or the adrenergic system, such as corticosteroids and beta-blockers;
- Patients undergoing atropine treatment (Hydroxyzine Chlorhydrate or Atarax®...), likely to modify the EDA (Electrodermal Activity) ;
- Patients with a known allergy to latex (watch EmbracePlus);
- Pregnant woman;
- Nursing woman;
- Persons deprived of their liberty by judicial or administrative decision, persons under psychiatric care;
- Persons under guardianship or trusteeship or subject to a legal protection measure
- Persons who are not affiliated to a social security scheme or are beneficiaries of such a scheme.
Key Trial Info
Start Date :
April 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 5 2026
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT06896045
Start Date
April 22 2025
End Date
February 5 2026
Last Update
September 29 2025
Active Locations (14)
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1
Angers University Hospital
Angers, France, 49100
2
Avignon Hospital
Avignon, France, 84000
3
Bordeaux University Hospital
Bordeaux, France, 33075
4
Brest University Hospital
Brest, France, 29200