NCT03893266

Brief Summary

Diabetes mellitus is an important disease around the world and the number of diabetic people increase every day. The type 1 diabetes often occurred in the youth and people have to learn to work with it and its complication. Conversely, diabetic people sometimes have trouble to manage their diabetes with working obligation. Actually, French therapeutic education don't teach how to reconcile diabetes and work. The study hypothesis is that type 1 diabetic people can be helped by therapeutic education in order to reconcile the management of their diabetes and their work. This study is a qualitative study. Interviews will help to find the needs of the type 1 diabetic patients to reconcile diabetes and work.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2019

Shorter than P25 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

First Submitted

Initial submission to the registry

March 26, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 28, 2019

Completed
29 days until next milestone

Study Start

First participant enrolled

April 26, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2019

Completed
Last Updated

March 31, 2020

Status Verified

March 1, 2020

Enrollment Period

7 months

First QC Date

March 26, 2019

Last Update Submit

March 27, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Collection of the needs of type 1 diabetic patients in therapeutic education in order to reconcile diabetes and work.

    It is a qualitative study consisting of type 1 diabetic patients semi-structured interviews in order to identify and describe their needs in therapeutic education in order to reconcile diabetes and work.

    Expected duration of interviews is around 1 hour, when no new idea appear in an interview.

Interventions

An interview will be realized with each patient in order to precise the issues they have to reconcile their diabetes and their work. Some questions will be posed to the patients and they respond as they wish.

Eligibility Criteria

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

Adult person with a type 1 diabetes and having paid employment

You may qualify if:

  • Age\>18 years old
  • To be diagnosed with type 1 diabetes according to the criteria of the French High Authority of Health and confirmed by an endocrinologist
  • To have paid employment with an employment contract during the study
  • to be informed and having no opposition to the study

You may not qualify if:

  • self-employed person
  • to be unemployed
  • To be diagnosed with an other disease wich could damage cognition or motricity and could interfere with work (cancer, neurodegenerative disorder, etc)
  • To have legal guardian.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Médecine et santé au travail - Hôpital Cardiologique Louis Pradel - Groupement hospitalier Est

Bron, 69677, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

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

Study Record Dates

First Submitted

March 26, 2019

First Posted

March 28, 2019

Study Start

April 26, 2019

Primary Completion

December 3, 2019

Study Completion

December 3, 2019

Last Updated

March 31, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations