Type 1 DiabetesNCT05662657
Prevalence of Post Traumatic Stress Disorder Related to Diabetes Diagnosis or Severe Hypoglycaemia in Adult With Type 1 Diabetes
An observational study of Type 1 Diabetes, run by Hospital St. Joseph, Marseille, France at 2 sites in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Diagnostic Test: PCL-S Questionnaire
- How many people
- 297 participants
- Where
- 2 sitesFrance
- Study dates
- 30 Nov 2022to 29 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: population of insulin-treated type 1 diabetic patients
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hopital Saint Joseph
Marseille, 13008
Centre Hospitalier de Martigues
Martigues, 13500
About this study
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.
Read more
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
- Being tested
- Diagnostic Test: PCL-S Questionnaire
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Test: PCL-S QuestionnaireDiagnostic test
Also called Diagnostic Test: HADS Questionnaire
PCL-S and HADS questionnaires
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: baseline
To demonstrate the presence of anxiety-depressive disorder related to PTSD
Rate of patients with anxiety depressive disorder associated with PTSD
Measured: 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)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start30 Nov 2022
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 297 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital St. Joseph, Marseille, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05662657
- Sponsor's protocol ID
- DIASPOT
- Status last verified
- Jan 2026
- First submitted
- 2 Dec 2022
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Post Traumatic Stress Disorder Related to Diabetes Diagnosis or Severe Hypoglycaemia in Adult With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05662657
- Acronym / sponsor ID
- DIASPOT
- Conditions
- Type 1 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 297 participants (actual)
- Lead sponsor
- Hospital St. Joseph, Marseille, FranceUniversity, hospital or other
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 22 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- population of insulin-treated type 1 diabetic patients
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic Test: PCL-S QuestionnaireAlso: Diagnostic Test: HADS QuestionnairePCL-S and HADS questionnaires | Diagnostic test | – |
Primary outcome
To evaluate the prevalence of post-traumatic stress disorder (PTSD) in adult with Type 1 Diabetes
Time frame: baseline
Score (>44) measured on the Posttraumatic Stress Disorder Checklist Scale (PCL-S) for severe hypoglycemia
6 secondary outcomes
To evaluate the prevalence of post-traumatic stress disorder (PTSD). This PTSD is related to diabetes diagnosis and its initial management.
Time frame: baseline
To evaluate the prevalence of post-traumatic stress disorder (PTSD) related to severe hypoglycemia.
Time frame: 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.
Time frame: baseline
To evaluate the prevalence of anxiety-depressive disorder in adults with type 1 diabetes
Time frame: baseline
To demonstrate the presence of anxiety-depressive disorder related to PTSD
Time frame: baseline
To evaluate whether there is a correlation between PTSD and the patient participation to a therapeutic education program
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by Hospital St. Joseph, Marseille, France at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the prevalence of post-traumatic stress disorder (PTSD) in adult with Type 1 Diabetes (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.