Clinical trial NCT06896045: Multicenter Study Evaluating the Relationship Between Perceived Daily Stress Level and Glycemic Level in Subjects With Type 1 Diabetes
Official title: Multicenter Study Evaluating the Relationship Between Perceived Daily Stress Level and Glycemic Level in Subjects With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes Type 1
Keywords: stress
glycemic control
Lead sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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).


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: 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)
timeFrame: 14 days
Secondary outcomes:
measure: HbA1c measurement
timeFrame: At Inclusion
measure: Characterization of 4 patient profiles according to the impact of daily stress on glycemic control
timeFrame: At inclusion
measure: Number of days the Continuous subcutaneous Glucose Monitoring (CGM) worn
timeFrame: 14 days
measure: Percentage of time the CGM is active (recommended at least 70% of the time)
timeFrame: 14 days
measure: Percentage of sensor time in glucose level measured by the Dexcom One+ CGM time
timeFrame: 14 days
measure: Variability of the CGM glucose level
timeFrame: 14 days
measure: Glucose management Indicator (GMI)
timeFrame: 14 days
measure: Average CGM glucose level
timeFrame: 14 days
measure: Glycaemic evolution over a period during which stress is measured.
timeFrame: 14 days
measure: Glycaemic evolution over a period during which stress is measured.
timeFrame: 14 days
measure: Glycaemic evolution over a period during which stress is measured.
timeFrame: 14 days
measure: Glycaemic evolution over a period during which stress is measured.
timeFrame: 14 days
measure: Measuring heart rate with the Empatica EmbracePlus watch
timeFrame: 14 days
measure: Measuring heart rate variability with the Empatica EmbracePlus watch
timeFrame: 14 days
measure: Measuring electrodermal activity with the Empatica EmbracePlus watch
timeFrame: 14 days
measure: Measuring heart rate with the Oura ring
timeFrame: 14 days
measure: Measuring heart rate variability with the Oura ring
timeFrame: 14 days
measure: Measuring accelerometry parameters with the Empatica EmbracePlus watch
timeFrame: 14 days
measure: Measuring accelerometry parameters with the Oura ring
timeFrame: 14 days
measure: Measuring the amount of sleep you get with the Empatica EmbracePlus watch
timeFrame: 14 days
measure: Measuring the amount of sleep you get with the Oura ring
timeFrame: 14 days
measure: Measuring total sleep time with the Oura ring
timeFrame: 14 days
measure: Assessment of sleep quality
timeFrame: 14 days
measure: Measurement of sleep characteristics with the Oura ring
timeFrame: 14 days
measure: Measurement of inflammatory biomarkers
timeFrame: at inclusion and after 14 days
measure: Capillary cortisol measurement
timeFrame: After 14 days
measure: Assessment of diabetes-related distress in the test population .
timeFrame: at inclusion
measure: Assessment of stress levels using the STAI questionnaire
timeFrame: At inclusion and after 14 days
measure: Assessment of stress levels using the STAI questionnaire
timeFrame: After 14 days
measure: Assessment of diabetes-related distress in the test population .
timeFrame: at inclusion and after 14 days
measure: Evaluation of the perception of hypoglycaemia in the population tested with Clarke score
timeFrame: at inclusion
measure: Evaluation of the perception of hypoglycaemia in the population tested with Gold score
timeFrame: at inclusion
measure: Assessment of stress levels using the PSS-14 questionnaire (Perceived Stress Scale 14)
timeFrame: at inclusion and after 14 days
measure: Assessment of stress levels : depression score
timeFrame: After 7 days
measure: Assessment of stress levels : anxiety score
timeFrame: After 7 days
measure: Assessment of stress levels : stress score
timeFrame: After 7 days
measure: Diagnosis and measurement of the severity of depression: Patient Health Questionnaire (PHQ-9)
timeFrame: After 7 days
measure: Personality traits : Big Five Inventory 10 (BFI-10)
timeFrame: After 7 days
measure: Bortner scale
timeFrame: After 7 days
measure: Quality of life assessment: Short Form 36 questionnaire (SF-36)
timeFrame: After 14 days
measure: Assessment of sleep quality: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: After 14 days
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospital
city: Avignon
country: France
facility: Avignon Hospital
city: Bordeaux
country: France
facility: Bordeaux University Hospital
city: Brest
country: France
facility: Brest University Hospital
city: Dijon
country: France
facility: Dijon University Hospital
city: Evry
country: France
facility: CERITD (Centre d'Etudes et de Recherches pour l'Intensification du Traitement du Diabète)
city: Grenoble
country: France
facility: Grenoble University Hospital
city: La Rochelle
country: France
facility: St Louis Hospital
city: Lille
country: France
facility: Lille University Hospital
city: Lyon
country: France
facility: DiabeCare diabetes centre
city: Marseille
country: France
facility: European Hospital
city: Mérignac
country: France
facility: Private practice in endocrinology and metabolic diseases
city: Rennes
country: France
facility: Rennes University Hospital
city: Strasbourg
country: France
facility: Strasbourg University Hospital
Study officials:
affiliation: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
name: Sylvia Franc, MD
role: PRINCIPAL_INVESTIGATOR
References: