Insulin-Dependent DiabetesPRE-SIMPANCT03956927
Feasibility of Simulation in Therapeutic Patient Education for Adult Diabetic Patients Using the Freestyle Libre® Device
An observational study of Insulin-Dependent Diabetes, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The benefits of Therapeutic Patient Education (TPE) have long been proven, but its implementation remains insufficient. It is only accessible to a part of the population and is too often limited to the acquisition of knowledge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insulin-Dependent Diabetes
- What is being tested?
- S-TPE and Questionnaires
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- 24 May 2019to 11 Jul 2019
- 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: Diabetic patients
Who may be able to join
- Adult who has provided non-opposition to participate in the study
- Insulin-dependent diabetic patient who has participated in a complete TPE program (3 sessions) for the implementation of a FreeStyle Libre®.
Who cannot join
- Person subject to a legal protection measure (curatorship, guardianship)
- Person subject to limited judicial protection
- Pregnant, parturient or breastfeeding woman
- Adulat patients unable to provide consent
Trial locations and contacts
1 site in 1 country.
About this study
The benefits of Therapeutic Patient Education (TPE) have long been proven, but its implementation remains insufficient. It is only accessible to a part of the population and is too often limited to the acquisition of knowledge. TPE consists of supporting the patient in making decisions about his or her health, managing his or her life with the disease and treatment through the acquisition or maintenance of skills.
Simulation is a pedagogical method of creating fictional or reconstructed environments in order to develop skills, know-how and abilities for which direct instruction is impossible for ethical, economic or technical reasons. To date, it is recommended for the development of caregiver skills, and has been the subject of two studies among family caregivers. It seems likely that simulation will add value to the methods currently used in TPE.
Read more
To our knowledge, no studies have been conducted on simulation-based TPE (S-TPE) with patients.
A consensus conference, which is a rigorous method of comparing the opinions of experts in TPE, simulation, patient experts and caregivers, was held in order to determine the learning that could be developed through simulation and the conditions of use. However, since the patient is a specific type of learner, we hypothesize that there may be some additional conditions for the use of S-TPE. And the value of this approach remains to be demonstrated. Since the use of S-TPE has never been studied with patients, a feasibility test would make it possible to evaluate, in the context of care, the possibility of its use and its acceptance by both patients and caregivers. This is necessary before considering a multicenter trial that demonstrates an interest in developing patient skills. It was decided to carry out this study in patients with diabetes, a condition for which TPE is a precursor. Caregivers will be able to objectify the advantages and limitations of using S-TPE.
- Conditions
- Insulin-Dependent Diabetes
- Being tested
- S-TPE, Questionnaires
- 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.
S-TPEOther
S-TPE stimulation session with groups of 8 patients. The simulation is performed by a single patient, the others are observers in a neighbouring room where the scene is projected.
QuestionnairesOther
Pre- and post-simulation administration of self-efficacy and anxiety questionnaires (IASTA Y1 and Y2)
| Study group | Role | What they receive |
|---|---|---|
| patients | Insulin-dependent diabetic patients who have participated in a full TPE program (3 sessions) Receives: Other: S-TPE; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of perceived utility of the S-TPE
The level of perceived utility of S-TPE for patients and caregivers through self-administered Likert scale questionnaires
Measured: Through study completion, an average of 9 months
Patient satisfaction: Likert scale
The degree of patient satisfaction at the end of the simulation sequence by self-administered questionnaire with a Likert scale
Measured: Through study completion, an average of 9 months
Organizational advantages and limitations
Organizational, human, material, material and temporal facilities and limitations for patients and caregivers by analyzing the verbatim of the T0 questionnaires and interviewing them at T1
Measured: Through study completion, an average of 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start24 May 2019
- Primary completion11 Jul 2019
- Study completion11 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insulin-Dependent DiabetesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956927
- Sponsor's protocol ID
- PENNECOT 2019
- Acronym
- PRE-SIMPA
- Status last verified
- Jan 2026
- First submitted
- 17 May 2019
- Last updated
- 3 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pennecot C, Luu M, Marchand C, Gagnayre R, Dechannes N, Rudoni S, Hilaire AM, Demongeot A, Capelle D, Bardou M. First use of Simulation in Therapeutic Patient Education (S-TPE) in adults with diabetes: a pilot study. BMJ Open. 2022 Feb 28;12(2):e049454. doi: 10.1136/bmjopen-2021-049454.
PubMed 35228274
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Simulation in Therapeutic Patient Education for Adult Diabetic Patients Using the Freestyle Libre® Device
- ClinicalTrials.gov ID
- NCT03956927
- Acronym / sponsor ID
- PRE-SIMPA / PENNECOT 2019
- Conditions
- Insulin-Dependent Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 24 May 2019 (actual)
- Primary completion
- 11 Jul 2019 (actual)
- Study completion
- 11 Jul 2019 (actual)
- First posted
- 21 May 2019 (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.
The benefits of Therapeutic Patient Education (TPE) have long been proven, but its implementation remains insufficient. It is only accessible to a part of the population and is too often limited to the acquisition of knowledge. TPE consists of supporting the patient in making decisions about his or her health, managing his or her life with the disease and treatment through the acquisition or maintenance of skills.
Simulation is a pedagogical method of creating fictional or reconstructed environments in order to develop skills, know-how and abilities for which direct instruction is impossible for ethical, economic or technical reasons. To date, it is recommended for the development of caregiver skills, and has been the subject of two studies among family caregivers. It seems likely that simulation will add value to the methods currently used in TPE.
To our knowledge, no studies have been conducted on simulation-based TPE (S-TPE) with patients.
A consensus conference, which is a rigorous method of comparing the opinions of experts in TPE, simulation, patient experts and caregivers, was held in order to determine the learning that could be developed through simulation and the conditions of use. However, since the patient is a specific type of learner, we hypothesize that there may be some additional conditions for the use of S-TPE. And the value of this approach remains to be demonstrated. Since the use of S-TPE has never been studied with patients, a feasibility test would make it possible to evaluate, in the context of care, the possibility of its use and its acceptance by both patients and caregivers. This is necessary before considering a multicenter trial that demonstrates an interest in developing patient skills. It was decided to carry out this study in patients with diabetes, a condition for which TPE is a precursor. Caregivers will be able to objectify the advantages and limitations of using S-TPE.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | – | Other: S-TPE, Other: QuestionnairesInsulin-dependent diabetic patients who have participated in a full TPE program (3 sessions) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic patients
Key inclusion criteria (2 listed)
- Adult who has provided non-opposition to participate in the study
- Insulin-dependent diabetic patient who has participated in a complete TPE program (3 sessions) for the implementation of a FreeStyle Libre®.
Key exclusion criteria (4 listed)
- Person subject to a legal protection measure (curatorship, guardianship)
- Person subject to limited judicial protection
- Pregnant, parturient or breastfeeding woman
- Adulat patients unable to provide consent
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 |
|---|---|---|
| S-TPES-TPE stimulation session with groups of 8 patients. The simulation is performed by a single patient, the others are observers in a neighbouring room where the scene is projected. | Other | patients |
| QuestionnairesPre- and post-simulation administration of self-efficacy and anxiety questionnaires (IASTA Y1 and Y2) | Other | patients |
Primary outcome
level of perceived utility of the S-TPE
Time frame: Through study completion, an average of 9 months
The level of perceived utility of S-TPE for patients and caregivers through self-administered Likert scale questionnaires
Patient satisfaction: Likert scale
Time frame: Through study completion, an average of 9 months
The degree of patient satisfaction at the end of the simulation sequence by self-administered questionnaire with a Likert scale
Organizational advantages and limitations
Time frame: Through study completion, an average of 9 months
Organizational, human, material, material and temporal facilities and limitations for patients and caregivers by analyzing the verbatim of the T0 questionnaires and interviewing them at T1
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 3 Feb 2026.
- Results publication: PubMed 35228274Pennecot C, Luu M, Marchand C, Gagnayre R, Dechannes N, Rudoni S, Hilaire AM, Demongeot A, Capelle D, Bardou M. First use of Simulation in Therapeutic Patient Education (S-TPE) in adults with diabetes: a pilot study. BMJ Open. 2022 Feb 28;12(2):e049454. doi: 10.1136/bmjopen-2021-049454.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insulin-Dependent Diabetes, run by Centre Hospitalier Universitaire Dijon at 1 site 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 2 inclusion and 4 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 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
level of perceived utility of the S-TPE (time frame: Through study completion, an average of 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03956927, which also lists 1 linked publication.
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 3 Feb 2026.