NCT03192228

Brief Summary

Therapeutic education programs allows in diabetic patients to promote self-care and better perception of the disease The multidisciplinary program of therapeutic education regroups in one day: individual interview, nutritional workshop, self-monitoring blood glucose workshop, physical activity and glycemic objectives workshop. At the end of the program, individual and personalized goals are given to the patient. This study aims to evaluate this program success rates and the psychological, anamnesis, and sociological factors linked to success.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2011

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2017

Completed
Last Updated

October 31, 2019

Status Verified

October 1, 2019

Enrollment Period

10 months

First QC Date

June 16, 2017

Last Update Submit

October 29, 2019

Conditions

Keywords

Diabetes Mellitus, Type 2 +Patient Education

Outcome Measures

Primary Outcomes (1)

  • Success rate of the therapeutic education program

    The rate of success of the program defined by a 50% improvement in the treatment adequacy score evaluated at 1 month

    one month

Secondary Outcomes (1)

  • Long term success rate of the therapeutic education program

    6 month

Interventions

Evaluation of the program rate of success rate by a score evaluating the different criteria that the patient was supposed to modify following the therapeutic education program: practice of a physical activity, reduction of the amount of fat in Diet, practice of self-monitoring blood sugar as a motivational tool and decreased distress related to diabetes

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This initial education program is intended for patients with type 2 diabetes: * who have recently been diagnosed with type 2 diabetes * or who have an HbA1c greater than 7% and unability to lower their blood glucose levels despite an optimal management by general practitioner but do not yet require insulin treatment

You may qualify if:

  • All Type 2 diabetic patients who participate in the multidisciplinary program
  • Signature information form and consent by the patient

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

June 16, 2017

First Posted

June 20, 2017

Study Start

July 1, 2011

Primary Completion

May 1, 2012

Study Completion

September 1, 2012

Last Updated

October 31, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share