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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05662657
• Other study ID #: DIASPOT
• Status: Recruiting
• Start date: November 30, 2022
• Est. completion date: February 29, 2024

Study information

• Verified date: February 2024
• Source: Hospital St. Joseph, Marseille, France
• Contact: Rahamia AHAMADA
• Phone: 0488731071
• Email: rahamada[@]hopital-saint-joseph.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: February 29, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Hypoglycemia
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Type 1 Diabetes

Intervention

Diagnostic Test:
• Diagnostic Test: PCL-S Questionnaire
PCL-S and HADS questionnaires

Locations

Country	Name	City	State
France	Hopital Saint Joseph	Marseille
France	Centre Hospitalier de Martigues	Martigues

Sponsors (1)

Lead Sponsor	Collaborator
Hospital St. Joseph, Marseille, France

Country where clinical trial is conducted

France, 

Outcome

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