Multicenter Study Evaluating the Relationship Between Perceived Daily Stress Level and Glycemic Level in Subjects With Type 1 Diabetes (EVASTRESS)

Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

Status

Enrolling

Conditions

Diabetes Type 1

Treatments

Behavioral: Assess stress levels 4 times a day before meals (morning, noon and evening and at bedtime) using a visual analogue scale

Study type

Interventional

Funder types

Other

Identifiers

NCT06896045

2024-A02296-41

Details and patient eligibility

About

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).

Enrollment

125 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.