NCT01961466

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
592

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 11, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

September 4, 2019

Status Verified

September 1, 2019

Enrollment Period

4.1 years

First QC Date

October 10, 2013

Last Update Submit

September 3, 2019

Conditions

Type 1 or 2 Diabetes

Outcome Measures

Primary Outcomes (1)

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

    At 1 year

Secondary Outcomes (1)

  • Scores on the scales

    At 1 year

Study Arms (1)

Diabetic patients

Other: psychological and social self-administered questionnaires

Interventions

psychological and social self-administered questionnairesOTHER
Diabetic patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Type 1 or 2 Diabetes

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Dijon

Dijon, 21079, France

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2013

First Posted

October 11, 2013

Study Start

December 1, 2010

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

September 4, 2019

Record last verified: 2019-09

Locations

FR(1)