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CompletedNCT05662657Updated Jan 9, 2026

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

An observational study in Type 1 Diabetes, sponsored by Hospital St. Joseph, Marseille, France. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-09.

Sponsored by Hospital St. Joseph, Marseille, France · Observational

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Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
297
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 271 studies in Diabetes Mellitus, Type 1 with a site in France — 40 open to participants now, 47 under way, 8 of them phase 3. Diabetes Mellitus, Type 1 · France.

Enrollment
29th of 78
297 · median 153
Started
2022
with 13 others
Observational
78 of 271
23 open now
Registered
219th of 271
by date

Among the 271 studies in Diabetes Mellitus, Type 1 with a site in France, this one is the 29th largest by enrollment of the 78 observational ones that give a count, is one of 14 that started in 2022, is one of 78 observational ones, and was the 219th registered.

Diabetes Mellitus, Type 1

3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.

Browse Diabetes Mellitus, Type 1 studies →

Open to participants now

40 of the 271 studies in Diabetes Mellitus, Type 1 with a site in France are open now. Recruiting first, the newest first:

35 more — sign in →

All 40 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 412 Diabetes Mellitus, Type 1 studies recruiting now, 128 (31%) set no upper age limit and 258 (63%) stop at 75 or younger; 185 take children under 18; 64 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 271 studies in Diabetes Mellitus, Type 1 with a site in France, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Type 1 Diabetes
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

population of insulin-treated type 1 diabetic patients

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
297 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testDiagnostic Test: PCL-S Questionnaire

    PCL-S and HADS questionnaires

    Also known as: Diagnostic Test: HADS Questionnaire

06

What researchers measure

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

    Time frame: baseline

Secondary outcomes

  1. 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.

    Time frame: baseline

  2. 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

    Time frame: baseline

  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.

    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

    Time frame: baseline

  4. 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.

    Time frame: baseline

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

    Rate of patients with anxiety depressive disorder associated with PTSD

    Time frame: baseline

  6. 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)

    Time frame: baseline

07

Study locations

2 sites
  • Hopital Saint Joseph
    Marseille, 13008, France
  • Centre Hospitalier de Martigues
    Martigues, 13500, France
08

References and documents

Individual participant data

Plan to share: 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

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2022 to primary completion in Feb 2024, 14 months.

Of 249 non-industry observational studies under Diabetes Mellitus, Type 1, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 78. This study's 14 months is below that.

Counting every sponsor, half of 299 studies reached it within 30 months; a quarter within 12 and three quarters within 69.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 2, 2022
First posted
Dec 22, 2022
StartActual
Nov 30, 2022
Primary completionActual
Feb 29, 2024
CompletionActual
Feb 29, 2024
Last update
Jan 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05662657
Lead sponsor
Hospital St. Joseph, Marseille, France
Responsible party
Sponsor
First posted
Dec 22, 2022
Start date
Nov 30, 2022
Primary completion
Feb 29, 2024
Completion
Feb 29, 2024
Last update
Jan 9, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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