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CompletedNCT01961466DPPUpdated Sep 4, 2019

Diabetes and Psychological Profile

An observational study in Type 1 or 2 Diabetes, sponsored by Centre Hospitalier Universitaire Dijon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-04.

Sponsored by Centre Hospitalier Universitaire Dijon · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
592
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Type 1 or 2 Diabetes

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03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 592 is above the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

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Lead sponsor

Centre Hospitalier Universitaire Dijon is the lead sponsor of 495 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Type 1 or 2 Diabetes

Inclusion criteria

  • patients who have been given information about the research
  • patients with National Health Insurance
  • diabetic patients (type 1 or 2)
  • patients > 18 ans

Exclusion criteria

Exclusion Criteria:

  • Adult patients under guardianship or intellectually dependent
  • patients without National Health Insurance
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
592 participants (actual)
Patient registry
No

Groups and cohorts

  • Diabetic patients

    Other: psychological and social self-administered questionnaires

Interventions

  • Otherpsychological and social self-administered questionnaires
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What researchers measure

Primary outcomes

  1. Correlations between glycemic balance (HbA1c) and the score on the Bortner self-questionnaire

    Time frame: At 1 year

Secondary outcomes

  1. Scores on the scales

    Time frame: At 1 year

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Study locations

1 site
  • CHU Dijon
    Dijon, 21079, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01961466
Lead sponsor
Centre Hospitalier Universitaire Dijon
Responsible party
Sponsor
First posted
Oct 11, 2013
Start date
Dec 1, 2010
Primary completion
Jan 1, 2015
Completion
Jan 1, 2015
Last update
Sep 4, 2019

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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