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

NCT05662657 | Completed

• 1 other identifier: DIASPOT
• Study Type: observational
• Target: 297
• Locations: 1 country
• Sites: 2

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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

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

  baseline

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

  baseline

• 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

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

  baseline

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

  baseline

Interventions

Diagnostic Test: PCL-S Questionnaire DIAGNOSTIC_TEST

PCL-S and HADS questionnaires

Also known as: Diagnostic Test: HADS Questionnaire

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

population of insulin-treated type 1 diabetic patients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital St. Joseph, Marseille, France: lead

Study Sites (2)

Hopital Saint Joseph

Marseille, 13008, France

Location

Centre Hospitalier de Martigues

Martigues, 13500, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 22, 2022
• Study Start: November 30, 2022
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)