National Epidemiological Study of the Possible Impact of Stress on Glycaemic Control in Patients With Type 1 Diabetes (EPISTRESS2)

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 Overview

• Status: Completed
• Conditions: Diabetes Type 1
• Intervention / Treatment: Other: questionnaires

• Study Type: Observational
• Enrollment (Actual): 1344

Contacts and Locations

Study Locations

• France
  • Angers, France, 49100
    • Angers University Hospital
  • Avignon, France, 84000
    • Avignon Hospital
  • Bordeaux, France, 33076
    • St André Hospital
  • Brest, France, 29200
    • Brest University Hospital
  • Dijon, France, 21079
    • Dijon University Hospital
  • Evry, France, 91058
    • CERITD
  • Grenoble, France, 38043
    • Grenoble University Hospital
  • Lille, France, 59037
    • Lille University Hospital
  • Marseille, France, 13000
    • APHM- La Conception Hospital
  • Mérignac, France, 33700
    • Private practice in endocrinology and metabolic diseases
  • Strasbourg, France, 67091
    • Srasbourg University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

To study the impact of stress on glycaemia, we chose to conduct an epidemiological study in France on a population of type 1 diabetic patients (T1DM).

Many patients frequently and systematically cite stress as a frequent cause, or even the main cause, of the deterioration in their glycaemic control.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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").	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)	30 minutes

Collaborators and Investigators

• Sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
• Investigators: Principal Investigator: Sylvia Franc, MD, Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2023
• Primary Completion (Actual): February 28, 2024
• Study Completion (Actual): February 28, 2024

Study Registration Dates

• First Submitted: April 8, 2024
• First Submitted That Met QC Criteria: April 12, 2024
• First Posted (Actual): April 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Stress; Glycemic control
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 2022-A01453-40

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No