Clinical trial NCT05662657: Prevalence of Post Traumatic Stress Disorder Related to Diabetes Diagnosis or Severe Hypoglycaemia in Adult With Type 1 Diabetes
Official title: Prevalence of Post Traumatic Stress Disorder Related to Diabetes Diagnosis or Severe Hypoglycaemia in Adult With Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 1 Diabetes
Lead sponsor: Hospital St. Joseph, Marseille, France
Sponsor class: OTHER
First posted: 2022-12-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: population of insulin-treated type 1 diabetic patients

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.


Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate the prevalence of post-traumatic stress disorder (PTSD) in adult with Type 1 Diabetes
timeFrame: baseline
Secondary outcomes:
measure: To evaluate the prevalence of post-traumatic stress disorder (PTSD). This PTSD is related to diabetes diagnosis and its initial management.
timeFrame: baseline
measure: To evaluate the prevalence of post-traumatic stress disorder (PTSD) related to severe hypoglycemia.
timeFrame: baseline
measure: 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.
timeFrame: baseline
measure: To evaluate the prevalence of anxiety-depressive disorder in adults with type 1 diabetes
timeFrame: baseline
measure: To demonstrate the presence of anxiety-depressive disorder related to PTSD
timeFrame: baseline
measure: To evaluate whether there is a correlation between PTSD and the patient participation to a therapeutic education program
timeFrame: baseline
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hopital Saint Joseph
city: Martigues
country: France
facility: Centre Hospitalier de Martigues
Study officials:
References: