Type 1 DiabeticNCT01530789
Paramedical Consultation in Telemedicine
An observational study of Type 1 Diabetic, run by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète.
Trial summary
Feasibility monocentrique opened study estimating the use of an electronic personalized educational plan (ePEP) for the follow-up by nurses of 50 patients diabetics type 1 during 6 months having an electronic pad. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Type 1 Diabetic
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Apr 2014
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Diabetic type 1 patients with the electronic pad
Who may be able to join
- patient diabetic type 1
- patient with the electronic pad in a smartphone
- adults
- children between 12 and 17 years 11 months
- patient having signed the consent
Who cannot join
- patient diabetic type 2
- patient without the electronic pad in a smartphone
- children below 12 years old
About this study
Official title: Evaluation of Paramedical Consultation in Type 1 Diabetic Patients in Telemedicine
Feasibility monocentrique opened study estimating the use of an electronic personalized educational plan (ePEP) for the follow-up by nurses of 50 patients diabetics type 1 during 6 months having an electronic pad.
- Conditions
- Type 1 Diabetic
- Keywords
- Telemedecine, Telemedecine nurse, Delegation of tasks, Type 1 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patient using the system
The using of the system is estimated by the frequency of dose proposition by electronic pad
Measured: 6 month
Secondary outcomes (3)
satisfaction level of the patient and quality of life
Measured: 6 month
satisfaction level of physician
The satisfaction level of physician about the follow-up by e-PEP
Measured: 6 month
satisfaction level of the telemedecin nurse
Evaluation of the satisfaction level of the telemedecin nurse about the follow-up by e-PEP
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2012 (estimated)
- Study startMay 2011
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabeticStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01530789
- Sponsor's protocol ID
- 2011-A00311-40
- Status last verified
- Oct 2012
- First submitted
- 8 Feb 2012
- Last updated
- 6 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Paramedical Consultation in Type 1 Diabetic Patients in Telemedicine
- ClinicalTrials.gov ID
- NCT01530789
- Acronym / sponsor ID
- 2011-A00311-40
- Conditions
- Type 1 Diabetic
- Keywords
- Telemedecine, Telemedecine nurse, Delegation of tasks, Type 1 diabetes
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre d'Etudes et de Recherche pour l'Intensification du Traitement du DiabèteUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 10 Feb 2012 (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.
Feasibility monocentrique opened study estimating the use of an electronic personalized educational plan (ePEP) for the follow-up by nurses of 50 patients diabetics type 1 during 6 months having an electronic pad.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Diabetic type 1 patients with the electronic pad
Key inclusion criteria (5 listed)
- patient diabetic type 1
- patient with the electronic pad in a smartphone
- adults
- children between 12 and 17 years 11 months
- patient having signed the consent
Key exclusion criteria (3 listed)
- patient diabetic type 2
- patient without the electronic pad in a smartphone
- children below 12 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of patient using the system
Time frame: 6 month
The using of the system is estimated by the frequency of dose proposition by electronic pad
3 secondary outcomes
satisfaction level of the patient and quality of life
Time frame: 6 month
satisfaction level of physician
Time frame: 6 month
satisfaction level of the telemedecin nurse
Time frame: 6 month
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2015.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetic, run by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète.
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 3 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: stopped early, as of the sponsor's last update on 6 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early. Results are not available in the source record.
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?
Percentage of patient using the system (time frame: 6 month). 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 6 Aug 2015.