NCT02461511

Brief Summary

To Assess the impact of therapeutic education on:

  • the occurrence of long term diabetes complications .
  • balance of his diabetes

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2015

Status
withdrawn

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

March 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

July 26, 2022

Status Verified

July 1, 2022

Enrollment Period

1.5 years

First QC Date

June 1, 2015

Last Update Submit

July 22, 2022

Conditions

Diabetes Complications

Outcome Measures

Primary Outcomes (1)

  • glycated hemoglobin measure

    blood sample

    3 months

Secondary Outcomes (1)

  • hopitalization

    3 months

Study Arms (3)

Therapeutic Education + Documentation

diabetic patient hospitalized patient particpating in therapeutic education program

Other: Therapeutic Education

No Therapeutic Education No Documents

diabetic patient hospitalized patient without therapeutic education program no documentation submitted

Documentation, No Therapeutic Education

diabetic patient hospitalized patient without therapeutic education program documentation submitted

Interventions

Therapeutic EducationOTHER

participation in a therapeutic education program on diabetes

Therapeutic Education + Documentation

Eligibility Criteria

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

diabetics hospitalized patients

You may qualify if:

  • diabetic
  • hospitalized in Léon Berard
  • with telephone line
  • written consent given
  • belong to a social security system

You may not qualify if:

  • no diabetics
  • patient having alredy completing a therapeutic education program
  • minor patient (\<18 years)
  • pregnant woman
  • without telephone line
  • no belong to a social security system
  • patient alredy inclued on clinical study.
  • patient tutelage or under curatorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Complications

Condition Hierarchy (Ancestors)

Diabetes MellitusEndocrine System Diseases

Study Officials

  • Alkassoum Sapha, Medecin

    medecin

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

June 1, 2015

First Posted

June 3, 2015

Study Start

March 1, 2015

Primary Completion

September 1, 2016

Study Completion

November 1, 2016

Last Updated

July 26, 2022

Record last verified: 2022-07