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

Recruiting

• Conditions: Type 1 Diabetes

• Registration Number: NCT05662657
• Lead Sponsor: Hospital St. Joseph, Marseille, France

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-30
• Study First Submitted: 2022-12-02
• Study First Submitted QC: 2022-12-14
• Study First Posted: 2022-12-22
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-14
• Last Update Posted: 2024-02-15
• Primary Completion: 2024-02-29
• Study Completion: 2024-02-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the prevalence of post-traumatic stress disorder (PTSD) in adult with Type 1 Diabetes	baseline	Score (\>44) measured on the Posttraumatic Stress Disorder Checklist Scale (PCL-S) for severe hypoglycemia

Secondary Outcome Measures

Name	Time	Method
To evaluate the prevalence of post-traumatic stress disorder (PTSD). This PTSD is related to diabetes diagnosis and its initial management.	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.
To evaluate the prevalence of anxiety-depressive disorder in adults with type 1 diabetes	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.
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.	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
To demonstrate the presence of anxiety-depressive disorder related to PTSD	baseline	Rate of patients with anxiety depressive disorder associated with PTSD
To evaluate the prevalence of post-traumatic stress disorder (PTSD) related to severe hypoglycemia.	baseline	Score (\>44) measured on the Posttraumatic Stress Disorder Checklist Scale (PCL-S) for severe hypoglycemia
To evaluate whether there is a correlation between PTSD and the patient participation to a therapeutic education program	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)

Trial Locations

Locations (2)

Centre Hospitalier de Martigues; 🇫🇷 Martigues, France

Hopital Saint Joseph; 🇫🇷 Marseille, France