Diabetes Mellitus, Type 1ET-DITNCT03893266
Diabetic Patients Needs in Therapeutic Education About Work. TE-DIW (Therapeutic Education of DIabetic Working People)
An observational study of Diabetes Mellitus, Type 1, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Diabetes mellitus is an important disease around the world and the number of diabetic people increase every day. The type 1 diabetes often occurred in the youth and people have to learn to work with it and its complication. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Interviews
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 26 Apr 2019to 3 Dec 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult person with a type 1 diabetes and having paid employment
Who may be able to join
- Age>18 years old
- To be diagnosed with type 1 diabetes according to the criteria of the French High Authority of Health and confirmed by an endocrinologist
- To have paid employment with an employment contract during the study
- to be informed and having no opposition to the study
Who cannot join
- self-employed person
- to be unemployed
- To be diagnosed with an other disease wich could damage cognition or motricity and could interfere with work (cancer, neurodegenerative disorder, etc)
- To have legal guardian.
Trial locations and contacts
1 site in 1 country.
France1 site
Médecine et santé au travail - Hôpital Cardiologique Louis Pradel - Groupement hospitalier Est
Bron, 69677
About this study
Official title: Exploratory Study of the Needs of Type 1 Diabetic Patients in Therapeutic Education in Order to Reconcile Diabetes and Work.
Diabetes mellitus is an important disease around the world and the number of diabetic people increase every day. The type 1 diabetes often occurred in the youth and people have to learn to work with it and its complication. Conversely, diabetic people sometimes have trouble to manage their diabetes with working obligation. Actually, French therapeutic education don't teach how to reconcile diabetes and work. The study hypothesis is that type 1 diabetic people can be helped by therapeutic education in order to reconcile the management of their diabetes and their work. This study is a qualitative study. Interviews will help to find the needs of the type 1 diabetic patients to reconcile diabetes and work.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Interviews
- 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.
InterviewsOther
An interview will be realized with each patient in order to precise the issues they have to reconcile their diabetes and their work. Some questions will be posed to the patients and they respond as they wish.
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of the needs of type 1 diabetic patients in therapeutic education in order to reconcile diabetes and work.
It is a qualitative study consisting of type 1 diabetic patients semi-structured interviews in order to identify and describe their needs in therapeutic education in order to reconcile diabetes and work.
Measured: Expected duration of interviews is around 1 hour, when no new idea appear in an interview.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start26 Apr 2019
- Primary completion3 Dec 2019
- Study completion3 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03893266
- Sponsor's protocol ID
- 69HCL18_0824
- Acronym
- ET-DIT
- Status last verified
- Mar 2020
- First submitted
- 26 Mar 2019
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of the Needs of Type 1 Diabetic Patients in Therapeutic Education in Order to Reconcile Diabetes and Work.
- ClinicalTrials.gov ID
- NCT03893266
- Acronym / sponsor ID
- ET-DIT / 69HCL18_0824
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 26 Apr 2019 (actual)
- Primary completion
- 3 Dec 2019 (actual)
- Study completion
- 3 Dec 2019 (actual)
- First posted
- 28 Mar 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.
Diabetes mellitus is an important disease around the world and the number of diabetic people increase every day. The type 1 diabetes often occurred in the youth and people have to learn to work with it and its complication. Conversely, diabetic people sometimes have trouble to manage their diabetes with working obligation. Actually, French therapeutic education don't teach how to reconcile diabetes and work. The study hypothesis is that type 1 diabetic people can be helped by therapeutic education in order to reconcile the management of their diabetes and their work. This study is a qualitative study. Interviews will help to find the needs of the type 1 diabetic patients to reconcile diabetes and work.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult person with a type 1 diabetes and having paid employment
Key inclusion criteria (4 listed)
- Age>18 years old
- To be diagnosed with type 1 diabetes according to the criteria of the French High Authority of Health and confirmed by an endocrinologist
- To have paid employment with an employment contract during the study
- to be informed and having no opposition to the study
Key exclusion criteria (4 listed)
- self-employed person
- to be unemployed
- To be diagnosed with an other disease wich could damage cognition or motricity and could interfere with work (cancer, neurodegenerative disorder, etc)
- To have legal guardian.
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 |
|---|---|---|
| InterviewsAn interview will be realized with each patient in order to precise the issues they have to reconcile their diabetes and their work. Some questions will be posed to the patients and they respond as they wish. | Other | – |
Primary outcome
Collection of the needs of type 1 diabetic patients in therapeutic education in order to reconcile diabetes and work.
Time frame: Expected duration of interviews is around 1 hour, when no new idea appear in an interview.
It is a qualitative study consisting of type 1 diabetic patients semi-structured interviews in order to identify and describe their needs in therapeutic education in order to reconcile diabetes and work.
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 31 Mar 2020.
- Individual participant dataSharing planned: No
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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 Diabetes Mellitus, Type 1, run by Hospices Civils de Lyon 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 4 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 31 Mar 2020. 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?
Collection of the needs of type 1 diabetic patients in therapeutic education in order to reconcile diabetes and work. (time frame: Expected duration of interviews is around 1 hour, when no new idea appear in an interview.). 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 31 Mar 2020.