Impact of a Multidisciplinary Therapeutic Education Program Being Set up for Patients With Type 2 Diabetes Mellitus

Evaluation of a Multidisciplinary Program of Therapeutic Education in Type 2 Diabetes Mellitus Diabetes in Order to Fix Individualized Objectives

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Patient Education as Topic
• Intervention / Treatment: Other: Treatment adequacy score

• Study Type: Observational
• Enrollment (Actual): 120

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long term 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 6 month	6 month

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Pitie-Salpetriere

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: June 16, 2017
• First Submitted That Met QC Criteria: June 16, 2017
• First Posted (Actual): June 20, 2017

Study Record Updates

• Last Update Posted (Actual): October 31, 2019
• Last Update Submitted That Met QC Criteria: October 29, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Patient Education; Diabetes Mellitus, Type 2 +
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: CIC1421-10-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No