Diabetes Type 1
Conditions
Keywords
Stress, Glycemic control
Brief summary
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.
Interventions
OTHERquestionnaires
filling in questionnaires
Sponsors
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary endpoint is the characterisation of 4 profiles of patients with type 1 diabetes on insulin pumps. | 30 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identify sub-populations of patients who feel stressed | 30 minutes | * 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 |
| Establish and categorise the different stress factors | 30 minutes | 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. |
| Establishing a relationship between personality type and the impact of stress | 30 minutes | 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). |
| Evaluation of the quality of life score obtained according to the 4 profiles and/or personalities | 30 minutes | 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) |
Countries
France
Outcome results
None listed