Type 1 or 2 DiabetesEPRIDIANCT02159417
Therapeutic Education of the Patients Diabetics Imprisoned at the Paris Jail
A study testing Therapeutic Education in people with Type 1 or 2 Diabetes, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
A lot of data show that therapeutic education is beneficial for diabetic patients. In the French jails, there are very few programs of therapeutic education while this population is usually precarious with no access at care sector before the jail. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Type 1 or 2 Diabetes
- What is being tested?
- Therapeutic Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesFrance
- Study dates
- Nov 2013to Feb 2015
- Phase
- Interventional
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patient detained in the MAPLS of more than 18 years
- Patient prisoner in the MAPLS for more than 15 days
- Patient follow-up for a diabetes of type 1 or type 2
- Patient informed about the study and not having opposed to this one
- Patient taken out of the disciplinary district which had previously been included for this motive
Who cannot join
- Patient considered incapable by the investigator to follow an ETP program
- Patient having a bad understanding of the spoken French language
- Patient whose duration of confinement known about the MAPLS is strictly lower than 1 month in the inclusion during the year 2013/2014
- Patient prisoner in the district of isolation
- Patient prisoner in the disciplinary district in the inclusion
- Patient prohibition to communicate with another prisoner already registered on the session to come
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital COCHIN
Paris, 75014
Maison d'Arrêt Paris La Santé (MAPLS)
Paris, 75014
About this study
Official title: Feasibility of the Therapeutic Education of the Patients Diabetics Imprisoned at the Paris Jail "La Santé" (Maison d'arrêt Paris La Santé)"
A lot of data show that therapeutic education is beneficial for diabetic patients. In the French jails, there are very few programs of therapeutic education while this population is usually precarious with no access at care sector before the jail.
The purpose of this study is to determinate if the therapeutic education of the diabetic patients is possible in the Paris jail "La Santé".
Read the detailed description
The Paris jail "La Santé" welcomes 600 men who stay 5 month on average. Each year, there are between 30 to 40 diabetic patients. In the jail there's a sanitary unit who is a unit of internal medicine of Cochin hospital. This unit includes nurses, pharmacists and medical doctors.
We propose to include in this study all diabetic patients (type 1 and 2) with the realization of a consultation of educational diagnosis, followed by the participation for every patient to 4 educational collective workshops therapeutic (knowledge of the disease, food, physical Activity and care of feet, the therapeutics)
- Conditions
- Type 1 or 2 Diabetes
- Being tested
- Therapeutic Education
- Keywords
- Evolution of the sport, HbA1C, IMC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic EducationOther
Also called Intensive training individual and collective teaching
Realization of a consultation of educational diagnosis, followed by the participation for every patient to 4 educational collective workshops therapeutic:
- Knowledge of the disease
- Food
- Physical Activity and care of feet
- The therapeutics
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Education | Experimental | Intensive training individual or collective teaching Receives: Other: Therapeutic Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
The feasibility of the application of the action ETP in the MAPLS
Rate of participation to at least two therapeutic workshops
Measured: 3 months
Secondary outcomes (4)
Estimation of the satisfaction of the prisoners and the nursing after participation of educational therapeutic workshops
To fill in an auto-questionnaire by means of the scale of Likert in 5 points
Measured: 3 months
biomedical parameters: HbA1c and IMC
Clinical evolution of the patients
Measured: 3 months
The number of hours all in all, for all the activities ETP and by categories of tasks
To evaluate of the mobilized resources
Measured: 3 months
The satisfaction of the staffs as for the implementation and the realization of the experiment
to evaluate of the mobilized resources
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2014 (estimated)
- Study startNov 2013
- Primary completionOct 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 or 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Benjamin SILBERMANN, MD, PhD, Study director, Assistance Publique - Hôpitaux de ParisLaura HARCOUET, Pharm D, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02159417
- Sponsor's protocol ID
- 2013-A00704-41
- Acronym
- EPRIDIA
- Status last verified
- Sep 2025
- First submitted
- 5 Jun 2014
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of the Therapeutic Education of the Patients Diabetics Imprisoned at the Paris Jail "La Santé" (Maison d'arrêt Paris La Santé)"
- ClinicalTrials.gov ID
- NCT02159417
- Acronym / sponsor ID
- EPRIDIA / 2013-A00704-41
- Conditions
- Type 1 or 2 Diabetes
- Keywords
- Evolution of the sport, HbA1C, IMC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Nov 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 9 Jun 2014 (estimated)
- 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.
A lot of data show that therapeutic education is beneficial for diabetic patients. In the French jails, there are very few programs of therapeutic education while this population is usually precarious with no access at care sector before the jail.
The purpose of this study is to determinate if the therapeutic education of the diabetic patients is possible in the Paris jail "La Santé".
Detailed description
The Paris jail "La Santé" welcomes 600 men who stay 5 month on average. Each year, there are between 30 to 40 diabetic patients. In the jail there's a sanitary unit who is a unit of internal medicine of Cochin hospital. This unit includes nurses, pharmacists and medical doctors.
We propose to include in this study all diabetic patients (type 1 and 2) with the realization of a consultation of educational diagnosis, followed by the participation for every patient to 4 educational collective workshops therapeutic (knowledge of the disease, food, physical Activity and care of feet, the therapeutics)
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Education | Experimental | Other: Therapeutic EducationIntensive training individual or collective teaching |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male patient detained in the MAPLS of more than 18 years
- Patient prisoner in the MAPLS for more than 15 days
- Patient follow-up for a diabetes of type 1 or type 2
- Patient informed about the study and not having opposed to this one
- Patient taken out of the disciplinary district which had previously been included for this motive
Key exclusion criteria (6 listed)
- Patient considered incapable by the investigator to follow an ETP program
- Patient having a bad understanding of the spoken French language
- Patient whose duration of confinement known about the MAPLS is strictly lower than 1 month in the inclusion during the year 2013/2014
- Patient prisoner in the district of isolation
- Patient prisoner in the disciplinary district in the inclusion
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 |
|---|---|---|
| Therapeutic EducationAlso: Intensive training individual and collective teachingRealization of a consultation of educational diagnosis, followed by the participation for every patient to 4 educational collective workshops therapeutic: * Knowledge of the disease * Food * Physical Activity and care of feet * The therapeutics | Other | Therapeutic Education |
Primary outcome
The feasibility of the application of the action ETP in the MAPLS
Time frame: 3 months
Rate of participation to at least two therapeutic workshops
4 secondary outcomes
Estimation of the satisfaction of the prisoners and the nursing after participation of educational therapeutic workshops
Time frame: 3 months
biomedical parameters: HbA1c and IMC
Time frame: 3 months
The number of hours all in all, for all the activities ETP and by categories of tasks
Time frame: 3 months
The satisfaction of the staffs as for the implementation and the realization of the experiment
Time frame: 3 months
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 20 Nov 2025.
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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.
Benjamin SILBERMANN, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
Laura HARCOUET, Pharm D study director
Assistance Publique - Hôpitaux de Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Education in people with Type 1 or 2 Diabetes, run by Assistance Publique - Hôpitaux de Paris 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 6 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 20 Nov 2025. 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?
The feasibility of the application of the action ETP in the MAPLS (time frame: 3 months). 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 20 Nov 2025; AzTrials last refreshed its copy on 8 Nov 2026.