Type 1 or 2 DiabetesDPPNCT01961466
Diabetes and Psychological Profile
An observational study of Type 1 or 2 Diabetes, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
This study is based on the analysis of psychological and social questionnaires filled in by diabetic patients whose glycemic balance will be assessed by measuring blood levels of glycated haemoglobin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 or 2 Diabetes
- What is being tested?
- psychological and social self-administered questionnaires
- How many people
- 592 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2010to 1 Jan 2015
- 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: Type 1 or 2 Diabetes
Who may be able to join
- patients who have been given information about the research
- patients with National Health Insurance
- diabetic patients (type 1 or 2)
- patients > 18 ans
Who cannot join
- Adult patients under guardianship or intellectually dependent
- patients without National Health Insurance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study on the Influence of Psychosocial Variables (Stress, Type A Behaviour Pattern, Quality of Life of the Diabetic) on Glycemic Balance in Patients With Type 1 and 2 Diabetes.
This study is based on the analysis of psychological and social questionnaires filled in by diabetic patients whose glycemic balance will be assessed by measuring blood levels of glycated haemoglobin. The aim is to compare glycemic balance by measuring HbA1c in diabetic patients (type 1 and 2) according to whether they have a Type A or B psychosomatic profile evaluated by the Bortner self-questionnaire.
- Conditions
- Type 1 or 2 Diabetes
- Being tested
- psychological and social self-administered questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychological and social self-administered questionnairesOther
| Study group | Role | What they receive |
|---|---|---|
| Diabetic patients | Not described Receives: Other: psychological and social self-administered questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlations between glycemic balance (HbA1c) and the score on the Bortner self-questionnaire
Measured: At 1 year
Secondary outcomes (1)
Scores on the scales
Measured: At 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2013 (estimated)
- Study start1 Dec 2010
- Primary completion1 Jan 2015
- Study completion1 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 or 2 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 592 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
- NCT01961466
- Sponsor's protocol ID
- CHAUVET-GELINIER 2009
- Acronym
- DPP
- Status last verified
- Sep 2019
- First submitted
- 10 Oct 2013
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on the Influence of Psychosocial Variables (Stress, Type A Behaviour Pattern, Quality of Life of the Diabetic) on Glycemic Balance in Patients With Type 1 and 2 Diabetes.
- ClinicalTrials.gov ID
- NCT01961466
- Acronym / sponsor ID
- DPP / CHAUVET-GELINIER 2009
- Conditions
- Type 1 or 2 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 592 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 1 Dec 2010 (actual)
- Primary completion
- 1 Jan 2015 (actual)
- Study completion
- 1 Jan 2015 (actual)
- First posted
- 11 Oct 2013 (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.
This study is based on the analysis of psychological and social questionnaires filled in by diabetic patients whose glycemic balance will be assessed by measuring blood levels of glycated haemoglobin. The aim is to compare glycemic balance by measuring HbA1c in diabetic patients (type 1 and 2) according to whether they have a Type A or B psychosomatic profile evaluated by the Bortner self-questionnaire.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetic patients | – | Other: psychological and social self-administered questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type 1 or 2 Diabetes
Key inclusion criteria (4 listed)
- patients who have been given information about the research
- patients with National Health Insurance
- diabetic patients (type 1 or 2)
- patients > 18 ans
Key exclusion criteria (2 listed)
- Adult patients under guardianship or intellectually dependent
- patients without National Health Insurance
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 |
|---|---|---|
| psychological and social self-administered questionnaires | Other | Diabetic patients |
Primary outcome
Correlations between glycemic balance (HbA1c) and the score on the Bortner self-questionnaire
Time frame: At 1 year
1 secondary outcome
Scores on the scales
Time frame: At 1 year
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 4 Sep 2019.
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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 Type 1 or 2 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 4 inclusion and 2 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 4 Sep 2019. 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?
Correlations between glycemic balance (HbA1c) and the score on the Bortner self-questionnaire (time frame: At 1 year). 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 4 Sep 2019.