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NCT Number: NCT06365255

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

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.

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Key information

Conditions

Diabetes Type 1 Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Angers University Hospital, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

questionnaires

Other

filling in questionnaires

Primary outcomes

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

    Time frame: 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 outcomes

  1. Identify sub-populations of patients who feel stressed

    Time frame: 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

  2. Establish and categorise the different stress factors

    Time frame: 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.

  3. Establishing a relationship between personality type and the impact of stress

    Time frame: 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").

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

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: EPISTRESS2

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 15, 2024
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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