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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Diagnostic test: Diagnostic Test: PCL-S Questionnaire

• Study Type: Observational
• Enrollment (Actual): 297

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13008
    • Hôpital Saint Joseph
  • Martigues, France, 13500
    • Centre Hospitalier de Martigues

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

population of insulin-treated type 1 diabetic patients

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
To demonstrate the presence of anxiety-depressive disorder related to PTSD	Rate of patients with anxiety depressive disorder associated with PTSD	baseline
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

Collaborators and Investigators

• Sponsor: Hospital St. Joseph, Marseille, France

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2022
• Primary Completion (Actual): February 29, 2024
• Study Completion (Actual): February 29, 2024

Study Registration Dates

• First Submitted: December 2, 2022
• First Submitted That Met QC Criteria: December 14, 2022
• First Posted (Actual): December 22, 2022

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1
• Other Study ID Numbers: DIASPOT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The participants of this study did not give written consent for their data to be shared publicly, so due to the sensitive nature of the research supporting data is not available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No