NCT06365255

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,344

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 8, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 15, 2024

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

1.1 years

First QC Date

April 8, 2024

Last Update Submit

April 15, 2024

Conditions

Diabetes Type 1

Keywords

StressGlycemic control

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Identify sub-populations of patients who feel stressed

    30 minutes

  • Establish and categorise the different stress factors

    30 minutes

  • Establishing a relationship between personality type and the impact of stress

    30 minutes

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

    30 minutes

Interventions

questionnairesOTHER

filling in questionnaires

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Patient who has declared his opposition using the electronic non-opposition form
  • Patient with type 2 diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Angers University Hospital

Angers, 49100, France

Location

Avignon Hospital

Avignon, 84000, France

Location

St André Hospital

Bordeaux, 33076, France

Location

Brest University Hospital

Brest, 29200, France

Location

Dijon University Hospital

Dijon, 21079, France

Location

CERITD

Évry, 91058, France

Location

Grenoble University Hospital

Grenoble, 38043, France

Location

Lille University Hospital

Lille, 59037, France

Location

APHM- La Conception Hospital

Marseille, 13000, France

Location

Private practice in endocrinology and metabolic diseases

Mérignac, 33700, France

Location

Srasbourg University Hospital

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Sylvia Franc, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2024

First Posted

April 15, 2024

Study Start

January 17, 2023

Primary Completion

February 28, 2024

Study Completion

February 28, 2024

Last Updated

April 17, 2024

Record last verified: 2024-04

Locations

FR(11)