DiabetesAPPRO-FSLNCT04739124
Appropriation of the Connected Solution Freestyle Libre® in Adult Patients With Diabetes in the Context of Therapeutic Education
An observational study of Diabetes, run by Direction Centrale du Service de Santé des Armées at 2 sites in France.
Trial summary
Following the proposal to self-monitor by the Freestyle Libre® (FSL) connected object, in diabetic patients in the context of therapeutic education, regarding the appropriation of FSL, what works, for which patients , in what specific contexts and by what mechanisms does it govern? A multicentric observational… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Follow-up questionnaires and Interviews
- How many people
- 86 participants
- Where
- 2 sitesFrance
- Study dates
- 10 Jun 2021to 6 Sep 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will be composed of diabetic patients and their caregivers.
Who may be able to join
- Patients
- Have type 1 or type 2 diabetes (as included in the education program),
- Be of legal age (over 18 years old),
- Do not present legal protection measures due to incapacity (such as guardianship or guardianship).
- Be able to read and speak French (elementary school level)
- Be eligible for FSL prescription and authorize the sharing of your data in Libreview®
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- Be affiliated to a social security scheme
- Have an email address or a phone allowing internet use
- Caregivers
- Be registered on the roll of his professional order
- Hold the certificate of 40 hours of training in therapeutic education.
- Practice therapeutic education on a regular basis
Who cannot join
- Patients
- presenting contraindications to the use of Freestyle Libre® (known allergies to adhesive products, coagulation disorders, not treated with insulin therapy or with less than 3 insulin injections per day or continuously, not requiring glycemic monitoring or less than 3 times a day)
- Patient refusing to follow the education program,
- Minors, patients under administrative or judicial supervision)
- Pregnant women,
- Patients who cannot be contacted in an emergency,
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- Persons in a position to give their consent but with an inability to read / write the French language.
- Patients who do not have an email address or a phone allowing internet use.
- Caregivers
- Failure to register with the professional order (except those of the Army Health Service who are exempt)
- Non-possession of the 40-hour therapeutic education training certificate.
- Not practicing FSL education
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Avicenne
Bobigny, 93009
Hopital d'Instruction des Armées Bégin
Saint-Mandé, 94163
About this study
Following the proposal to self-monitor by the Freestyle Libre® (FSL) connected object, in diabetic patients in the context of therapeutic education, regarding the appropriation of FSL, what works, for which patients , in what specific contexts and by what mechanisms does it govern? A multicentric observational research will be conducted with mixed method design (follow-up using patient questionnaires) and semi-structured interviews of patients and caregivers.
- Conditions
- Diabetes
- Being tested
- Follow-up questionnaires, Interviews
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-up questionnairesOther
The patient normally follows the education program as usual but research specific data is collected:
- Biological sampling at the start and end of the education program (glycated hemoglobin).
- Retrieval of usage and glycemic balance data from the Libreview online platform (at one week, one month and three months of use)
- Iterative questionnaires allowing the study of factors of acceptance, appropriation and use (at the start of the study, at 4 weeks, at 12 weeks)
InterviewsOther
Semi-structured interviews will be carried out during the visits, either face-to-face or remotely.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic patients | Patients presenting type 1 or type 2 diabetes, eligible for the prescription of Freestyle Libre Receives: Other: Follow-up questionnaires; Other: Interviews | |
| Caregivers | Caregiver caring for diabetic patients and practicing therapeutic education on a regular basis Receives: Other: Follow-up questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between appropriation factors, intention to use, Freestyle Libre use and glycemic control
longitudinal multifactor analysis by structural equation modeling of the research model created specifically
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 posted4 Feb 2021
- Study start10 Jun 2021
- Primary completion6 Sep 2023
- Study completion6 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04739124
- Sponsor's protocol ID
- 2020PPRC11
- Acronym
- APPRO-FSL
- Status last verified
- Sep 2023
- First submitted
- 1 Feb 2021
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appropriation of the Connected Solution Freestyle Libre® in Adult Patients With Diabetes in the Context of Therapeutic Education
- ClinicalTrials.gov ID
- NCT04739124
- Acronym / sponsor ID
- APPRO-FSL / 2020PPRC11
- Conditions
- Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 6 Sep 2023 (actual)
- Study completion
- 6 Sep 2023 (actual)
- First posted
- 4 Feb 2021 (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.
Following the proposal to self-monitor by the Freestyle Libre® (FSL) connected object, in diabetic patients in the context of therapeutic education, regarding the appropriation of FSL, what works, for which patients , in what specific contexts and by what mechanisms does it govern? A multicentric observational research will be conducted with mixed method design (follow-up using patient questionnaires) and semi-structured interviews of patients and caregivers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic patients | – | Other: Follow-up questionnaires, Other: InterviewsPatients presenting type 1 or type 2 diabetes, eligible for the prescription of Freestyle Libre |
| Caregivers | – | Other: Follow-up questionnairesCaregiver caring for diabetic patients and practicing therapeutic education on a regular basis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be composed of diabetic patients and their caregivers.
Key inclusion criteria (12 listed)
- Patients
- Caregivers
Key exclusion criteria (12 listed)
- Patients
- Caregivers
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 |
|---|---|---|
| Follow-up questionnairesThe patient normally follows the education program as usual but research specific data is collected: * Biological sampling at the start and end of the education program (glycated hemoglobin). * Retrieval of usage and glycemic balance data from the Libreview online platform (at one week, one month and three months of use) * Iterative questionnaires allowing the study of factors of acceptance, appropriation and use (at the start of the study, at 4 weeks, at 12 weeks) | Other | Caregivers, Diabetic patients |
| InterviewsSemi-structured interviews will be carried out during the visits, either face-to-face or remotely. | Other | Diabetic patients |
Primary outcome
Correlation between appropriation factors, intention to use, Freestyle Libre use and glycemic control
Time frame: 3 months
longitudinal multifactor analysis by structural equation modeling of the research model created specifically
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 21 Sep 2023.
- Individual participant dataSharing planned: Undecided
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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 Diabetes, run by Direction Centrale du Service de Santé des Armées 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 12 inclusion and 12 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 21 Sep 2023. 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?
Correlation between appropriation factors, intention to use, Freestyle Libre use and glycemic control (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 21 Sep 2023.