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NCT Number: NCT05662657

Prevalence of Post Traumatic Stress Disorder Related to Diabetes Diagnosis or Severe Hypoglycaemia in Adult With Type 1 Diabetes

In France, the adult population living with diabetes in 2016 is estimated at more than 3.3 million patients treated. Type 1 diabetes (T1DM) represents 5.6% of diabetic patients (approximately 185,000 patients).

Numerous studies show that patients fear hypoglycemia, with an impact on their quality of life, sleep disorders and depressive symptoms. In addition, there is a metabolic impact with a problem of therapeutic compliance and an alteration of glycemic control.

This study examine the relation between Post Traumatic Stress disorder (PTSD) and diabetes diagnosis or severe hypoglycaemia in adults with Type 1 Diabetes.

The aim of this study is to evaluate the prevalence of PTSD in this population.

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Key information

Conditions

Type 1 Diabetes 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

Hopital Saint Joseph, Marseille, 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

  • 18 years of age or older,
  • With type 1 diabetes,
  • Willing and able to complete all the questionnaires in French,
  • Who have given oral consent,
  • being affiliated to a social security scheme or being a beneficiary of such a scheme.

Exclusion criteria

  • Non-diabetic type 1,
  • With an unstable psychiatric pathology,
  • Pregnant or breastfeeding women,
  • Subject to a measure for the protection of justice,
  • Having opposed the research.

Treatment and study plan

Diagnostic Test: PCL-S Questionnaire

Diagnostic Test

PCL-S and HADS questionnaires

Other names: Diagnostic Test: HADS Questionnaire

Primary outcomes

  1. To evaluate the prevalence of post-traumatic stress disorder (PTSD) in adult with Type 1 Diabetes

    Time frame: baseline

    Score (>44) measured on the Posttraumatic Stress Disorder Checklist Scale (PCL-S) for severe hypoglycemia

Secondary outcomes

  1. To evaluate the prevalence of post-traumatic stress disorder (PTSD). This PTSD is related to diabetes diagnosis and its initial management.

    Time frame: baseline

    Score (>44) measured on the Posttraumatic Stress Disorder Checklist Scale (PCL-S).

    The patient will complete the questionnaire once to evaluate PTSD related to both diabete diagnosis and its initial management.

  2. To evaluate the prevalence of post-traumatic stress disorder (PTSD) related to severe hypoglycemia.

    Time frame: baseline

    Score (>44) measured on the Posttraumatic Stress Disorder Checklist Scale (PCL-S) for severe hypoglycemia

  3. To evaluate the prevalence of post-traumatic stress disorder (PTSD). This PTSD is related to at least one of the following reasons : - severe hypoglycemia - diabetes diagnosis and its initial management.

    Time frame: baseline

    Score (>44) measured on the Posttraumatic Stress Disorder Checklist Scale (PCL-S).

    The patient will complete the questionnaire once to evaluate PTSD related to severe hypoglycemia and/or diabetes diagnosis and its initial management

  4. To evaluate the prevalence of anxiety-depressive disorder in adults with type 1 diabetes

    Time frame: baseline

    Score (from 0 to 42 ) measured on the Hospital Anxiety and Depression Scale (HADS)

    Total scores can be categorized into five levels:

    • HADS score of 7 or less = no symptoms,
    • HADS score of 8 to 10 = doubtful symptomatology,
    • HADS score of 11 or more = definite symptomatology.

  5. To demonstrate the presence of anxiety-depressive disorder related to PTSD

    Time frame: baseline

    Rate of patients with anxiety depressive disorder associated with PTSD

  6. To evaluate whether there is a correlation between PTSD and the patient participation to a therapeutic education program

    Time frame: baseline

    Percentage of patients with PTSD (PCL-S > 44) between groups of patients participating or not in a therapeutic education program (Functional Insulin Therapy or multidisciplinary education in day hospital or hospitalization)

Sponsors and collaborators

Lead sponsor

Hospital St. Joseph, Marseille, France

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 22, 2022
Registry last updated
Jan 9, 2026

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

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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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