Diabetes and Psychological Profile | NCT01961466

Studies
Diabetes and Psychological Profile

NCT01961466

Sponsor

Centre Hospitalier Universitaire Dijon

Status

Completed

Last Update Posted

Sep 4, 2019Actual

Enrollment

592Actual

Phase

Not provided

Conditions

Type 1 or 2 Diabetes

Interventions

psychological and social self-administered questionnaires

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2010Actual

Primary Completion Date

Jan 1, 2015Actual

Completion Date

Jan 1, 2015Actual

First Submitted Date

Oct 10, 2013

First Submission Date that Met QC Criteria

Oct 10, 2013

First Posted Date

Oct 11, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 3, 2019

Last Update Posted Date

Sep 4, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

592Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diabetic patients			Other: psychological and social self-administered questionnaires

Interventions

Name	Type	Description	Arm Group Labels	Other Names
psychological and social self-administered questionnaires	Other		Diabetic patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlations between glycemic balance (HbA1c) and the score on the Bortner self-questionnaire		At 1 year

Secondary Outcomes

Measure	Description	Time Frame
Scores on the scales		At 1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Type 1 or 2 Diabetes

Sampling Method

Non-Probability Sample