Multicenter Study Evaluating the Relationship Between Perceived Daily Stress Level and Glycemic Level in Subjects With Type 1 Diabetes
EVASTRESS
1 other identifier
interventional
125
1 country
14
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 systems (AIDs), which have resulted in a very significant improvement in glycaemic control and quality of life. These closed-loop (CL) devices are capable of effectively regulating the conventional factors associated with glycaemic disturbance, namely dietary intake and physical activity. However, they do not account of stress, which some subjects with T1D perceive as a major disrupter of their blood sugar levels. One of the reasons for this is undoubtedly that stress, unlike diet or physical activity, cannot be anticipated. Since stress is difficult to predict, it is also more difficult to study. Its onset, intensity, duration and progression are linked to the subject's experience, psychological state and environment. Not all patients respond to stress triggers in the same way. Some patients appear to be more reactive than others to these agents, particularly when they are exposed to them chronically or repeatedly, in an anxiety-provoking environment. This is known as chronic psychosocial stress, and it is this type of stress that seems to be most closely associated with glycaemic disturbance in subjects with T1D, most often in the form of hyperglycaemia and, more rarely, hypoglycaemia. However, there are no solid epidemiological or experimental data to support these observations. The study we propose is a prospective multicentre clinical trial in 125 subjects with T1D treated with insulin pumps or multi-injections at 14 French university centres. Our aim is to evaluate the relationship between interstitial glucose levels measured by CGM and perceived stress, assessed 4 times a day, away from mealtimes in order to avoid the impact of dietary glycaemia, using a "stressometer". This stressometer is an application designed by CERITD that can be downloaded to the patient's smartphone and consists of an electronic visual analogue scale (VAS) on which the level of stress felt is evaluated quantitatively (continuous value between 0 and 10).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2025
Shorter than P25 for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2025
CompletedFirst Posted
Study publicly available on registry
March 26, 2025
CompletedStudy Start
First participant enrolled
April 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 5, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 5, 2026
CompletedSeptember 29, 2025
September 1, 2025
10 months
February 28, 2025
September 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Correlation between perceived daily stress, self-assessed on a multi-daily basis using a mobile subjective stress assessment application called a "stress meter", and blood glucose levels measured by continuous glucose monitoring (CGM)
Visual analogue scale to assess stress levels: 0: I feel absolutely no stress 10: I feel extremely stressed
14 days
Secondary Outcomes (41)
HbA1c measurement
At Inclusion
Characterization of 4 patient profiles according to the impact of daily stress on glycemic control
At inclusion
Number of days the Continuous subcutaneous Glucose Monitoring (CGM) worn
14 days
Percentage of time the CGM is active (recommended at least 70% of the time)
14 days
Percentage of sensor time in glucose level measured by the Dexcom One+ CGM time
14 days
- +36 more secondary outcomes
Study Arms (1)
Visual analog scale to measure stress levels
EXPERIMENTALInterventions
In addition to stress assessment with the stress meter, patients will be fitted with a Continious Glucose Monitoring
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- Type 2 diabetic patient;
- Patient fitted with a closed loop (or artificial pancreas);
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Angers University Hospital
Angers, 49100, France
Avignon Hospital
Avignon, 84000, France
Bordeaux University Hospital
Bordeaux, 33075, France
Brest University Hospital
Brest, 29200, France
Dijon University Hospital
Dijon, 21079, France
CERITD (Centre d'Etudes et de Recherches pour l'Intensification du Traitement du Diabète)
Évry, 91058, France
Grenoble University Hospital
Grenoble, 38043, France
St Louis Hospital
La Rochelle, 17000, France
Lille University Hospital
Lille, 59037, France
DiabeCare diabetes centre
Lyon, 69008, France
European Hospital
Marseille, 13003, France
Private practice in endocrinology and metabolic diseases
Mérignac, 33700, France
Rennes University Hospital
Rennes, 35200, France
Strasbourg University Hospital
Strasbourg, 67091, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sylvia Franc, MD
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2025
First Posted
March 26, 2025
Study Start
April 22, 2025
Primary Completion
February 5, 2026
Study Completion
February 5, 2026
Last Updated
September 29, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share