National Epidemiological Study of the Possible Impact of Stress on Glycaemic Control in Patients With Type 1 Diabetes

Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète1,344 enrolled

Overview

The EPISTRESS2 study is a one-off cross-sectional epidemiological survey, carried out via an online form in patients with type 1 diabetes followed up by participating investigating centres. In type 1 diabetes (T1DM), studies on stress and its impact on glycaemia have led to ambiguous results, mainly because there are no solid epidemiological or experimental data in the literature. The aim of this study was to assess the impact of perceived stress on blood glucose levels in a population of subjects with T1DM at 10 national centres.

Study Type

OBSERVATIONAL

Enrollment

1,344

Conditions

Diabetes Type 1

Interventions

questionnairesOTHER

filling in questionnaires

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with type 1 diabetes; * Do not have a psychiatric pathology; * At least 18 years old; * Affiliated to the Social Security; * Having read the non-opposition form and not objecting to it. Exclusion Criteria: * Patient who has declared his opposition using the electronic non-opposition form * Patient with type 2 diabetes

Locations (11)

Angers University Hospital

Angers, France

Avignon Hospital

Avignon, France

St André Hospital

Bordeaux, France

Brest University Hospital

Brest, France

Dijon University Hospital

Dijon, France

CERITD

Évry, France

Grenoble University Hospital

Grenoble, France

Lille University Hospital

Lille, France

APHM- La Conception Hospital

Marseille, France

Private practice in endocrinology and metabolic diseases

Mérignac, France

...and 1 more locations

Outcomes

Primary Outcomes

The primary endpoint is the characterisation of 4 profiles of patients with type 1 diabetes on insulin pumps.

Questionnaire for Assessing the Impact of Stress on Blood Sugar Levels. This questionnaire was designed and developed by CERITD to assess the impact of perceived stress on blood glucose levels in T1DM patients.

Time frame: 30 minutes

Secondary Outcomes

Identify sub-populations of patients who feel stressed

* Identify and profile a sub-population of patients whose blood glucose levels rise in response to stress * Identify and profile a sub-population of patients whose blood glucose levels decrease in response to stress Questionnaire for Assessing the Impact of Stress on Blood Sugar Levels

Time frame: 30 minutes

Establish and categorise the different stress factors

Cungi brief stress evaluation scales The Cungi 1 scale is composed of 8 items. This questionnaire assesses patient stressors. The maximum score is 48, the minimum score is 8. A high score reflects a large number of stressors The Cungi 2 scale is composed of 11 items. This questionnaire assesses the patient's sensitivity to stress. The maximum score is 66, the minimum score is 11. A high score reflects a high senstivity of stress.

Time frame: 30 minutes

Establishing a relationship between personality type and the impact of stress

State-Trait Anxiety Inventory (STAI) questionnaire. The STAI-Y1 is composed of 20 items. This questionnaire assesses how the patient feels at the present moment. Patients are asked to score each question on a four-point scale (from 1 - corresponding to "not at all" to 4 - "much") The STAI-Y2 is composed of 20 items. This questionnaire assesses how the patient feels in general. Patients are asked to answer each question on a four-point scale (from 1 - corresponding to "almost never" to 4 - "almost always").

Time frame: 30 minutes

Evaluation of the quality of life score obtained according to the 4 profiles and/or personalities

EQ-5D-5L (European Quality of Life 5 Dimensions) questionnaire The EQ-5D-5L assesses five health dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is rated on five levels of severity. The levels of severity for each dimension ranges from no problems (1) to extreme problems/unable to perform (5)

Time frame: 30 minutes