Diabetes Mellitus, Type 2NCT03192228
Impact of a Multidisciplinary Therapeutic Education Program Being Set up for Patients With Type 2 Diabetes Mellitus
An observational study of Diabetes Mellitus, Type 2 and Patient Education as Topic, run by Groupe Hospitalier Pitie-Salpetriere.
Trial summary
Therapeutic education programs allows in diabetic patients to promote self-care and better perception of the disease The multidisciplinary program of therapeutic education regroups in one day: individual interview, nutritional workshop, self-monitoring blood glucose workshop, physical activity and glycemic objectives… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Patient Education as Topic
- What is being tested?
- Treatment adequacy score
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jul 2011to Sep 2012
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This initial education program is intended for patients with type 2 diabetes: * who have recently been diagnosed with type 2 diabetes * or who have an HbA1c greater than 7% and unability to lower their blood glucose levels despite an optimal management by general practitioner but do not yet require insulin treatment
Who may be able to join
- All Type 2 diabetic patients who participate in the multidisciplinary program
- Signature information form and consent by the patient
Who cannot join
- None
About this study
Official title: Evaluation of a Multidisciplinary Program of Therapeutic Education in Type 2 Diabetes Mellitus Diabetes in Order to Fix Individualized Objectives
Therapeutic education programs allows in diabetic patients to promote self-care and better perception of the disease The multidisciplinary program of therapeutic education regroups in one day: individual interview, nutritional workshop, self-monitoring blood glucose workshop, physical activity and glycemic objectives workshop.
At the end of the program, individual and personalized goals are given to the patient.
This study aims to evaluate this program success rates and the psychological, anamnesis, and sociological factors linked to success.
- Being tested
- Treatment adequacy score
- Keywords
- Diabetes Mellitus, Type 2 +, Patient Education
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment adequacy scoreOther
Evaluation of the program rate of success rate by a score evaluating the different criteria that the patient was supposed to modify following the therapeutic education program: practice of a physical activity, reduction of the amount of fat in Diet, practice of self-monitoring blood sugar as a motivational tool and decreased distress related to diabetes
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of the therapeutic education program
The rate of success of the program defined by a 50% improvement in the treatment adequacy score evaluated at 1 month
Measured: one month
Secondary outcomes (1)
Long term success rate of the therapeutic education program
The rate of success of the program defined by a 50% improvement in the treatment adequacy score evaluated at 6 month
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 posted20 Jun 2017
- Study startJul 2011
- Primary completionMay 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Pitie-Salpetriere
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03192228
- Sponsor's protocol ID
- CIC1421-10-15
- Status last verified
- Oct 2019
- First submitted
- 16 Jun 2017
- Last updated
- 31 Oct 2019
- 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 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Multidisciplinary Program of Therapeutic Education in Type 2 Diabetes Mellitus Diabetes in Order to Fix Individualized Objectives
- ClinicalTrials.gov ID
- NCT03192228
- Acronym / sponsor ID
- CIC1421-10-15
- Keywords
- Diabetes Mellitus, Type 2 +, Patient Education
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Groupe Hospitalier Pitie-SalpetriereUniversity, hospital or other
- Study start
- Jul 2011 (actual)
- Primary completion
- May 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 20 Jun 2017 (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.
Therapeutic education programs allows in diabetic patients to promote self-care and better perception of the disease The multidisciplinary program of therapeutic education regroups in one day: individual interview, nutritional workshop, self-monitoring blood glucose workshop, physical activity and glycemic objectives workshop.
At the end of the program, individual and personalized goals are given to the patient.
This study aims to evaluate this program success rates and the psychological, anamnesis, and sociological factors linked to success.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This initial education program is intended for patients with type 2 diabetes: * who have recently been diagnosed with type 2 diabetes * or who have an HbA1c greater than 7% and unability to lower their blood glucose levels despite an optimal management by general practitioner but do not yet require insulin treatment
Key inclusion criteria (2 listed)
- All Type 2 diabetic patients who participate in the multidisciplinary program
- Signature information form and consent by the patient
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Treatment adequacy scoreEvaluation of the program rate of success rate by a score evaluating the different criteria that the patient was supposed to modify following the therapeutic education program: practice of a physical activity, reduction of the amount of fat in Diet, practice of self-monitoring blood sugar as a motivational tool and decreased distress related to diabetes | Other | – |
Primary outcome
Success rate of the therapeutic education program
Time frame: one month
The rate of success of the program defined by a 50% improvement in the treatment adequacy score evaluated at 1 month
1 secondary outcome
Long term success rate of the therapeutic education program
Time frame: 6 month
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 Oct 2019.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Patient Education as Topic, run by Groupe Hospitalier Pitie-Salpetriere.
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 1 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 Oct 2019. 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 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?
Success rate of the therapeutic education program (time frame: one 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 31 Oct 2019.