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

• Sponsor: Hospital St. Joseph, Marseille, France (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05662657
• Collaborator: (none)
• Enrollment: 300
• Locations: 2
• Anticipated Duration (Months): 12
• Patients Per Site: 150
• Patients Per Site Per Month: 12.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes	Diagnostic Test: Diagnostic Test: PCL-S Questionnaire

Study Design

• Study Type: Observational
• Anticipated Enrollment: 300 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Prevalence of Post Traumatic Stress Disorder Related to Diabetes Diagnosis or Severe Hypoglycaemia in Adult With Type 1 Diabetes
• Actual Study Start Date: Nov 30, 2022
• Anticipated Primary Completion Date: Nov 30, 2023
• Anticipated Study Completion Date: Nov 30, 2023

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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

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. [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 [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 [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 [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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hopital Saint Joseph	Marseille		France	13008
2	Centre Hospitalier de Martigues	Martigues		France	13500

Sponsors and Collaborators

• Hospital St. Joseph, Marseille, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospital St. Joseph, Marseille, France
• ClinicalTrials.gov Identifier: NCT05662657
• Other Study ID Numbers: DIASPOT
• First Posted: Dec 22, 2022
• Last Update Posted: Dec 22, 2022
• Last Verified: Dec 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic

Study Results

No Results Posted as of Dec 22, 2022