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

Completed

• Conditions: Diabetes Type 1

• Registration Number: NCT06365255
• Lead Sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-17
• Primary Completion: 2024-02-28
• Study Completion: 2024-02-28
• Status Verified: 2024-04
• Study First Submitted: 2024-04-08
• Study First Submitted QC: 2024-04-12
• Study First Posted: 2024-04-15
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1344

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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)
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
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").

Trial Locations

Locations (11)

CERITD; 🇫🇷 Evry, France

Angers University Hospital; 🇫🇷 Angers, France

Avignon Hospital; 🇫🇷 Avignon, France

St André Hospital; 🇫🇷 Bordeaux, France

Brest University Hospital; 🇫🇷 Brest, France

Dijon University Hospital; 🇫🇷 Dijon, France

Grenoble University Hospital; 🇫🇷 Grenoble, France

Lille University Hospital; 🇫🇷 Lille, France

APHM- La Conception Hospital; 🇫🇷 Marseille, France

Srasbourg University Hospital; 🇫🇷 Strasbourg, France

Private practice in endocrinology and metabolic diseases; 🇫🇷 Mérignac, France