Value-based Care in Type 2 Diabetes (Enhancing T2D Care)

Not Applicable

Not yet recruiting

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT06774950
• Lead Sponsor: Réseau de soins Delta

Brief Summary

The aim of this study is to obtain a better glycemic index score (decrease) by improving the care and quality of life of type 2 diabetic patients for a possible remission of diabetes.

This will be achieved through an intervention that includes a strategy for training primary care physicians and other healthcare professionals in patient therapeutic education (TPE), as well as group and/or individual TPE-related activities/tools made available to patients, funded and encouraged for individualized planning. Intervention follow-up will be carried out by means of quality-of-life questionnaires for patients who have undergone the new method, compared with patients who have received the usual care.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-10
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-13
• Last Update Submitted: 2025-01-13
• Study First Posted: 2025-01-14
• Last Update Posted: 2025-01-14
• Study Start: 2025-03-01
• Primary Completion: 2025-08-01
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

• Patients with newly diagnosed type 2 diabetes (less than 10 years)
• Age (between 40 and 65)

Exclusion Criteria

• Significant comorbidities linked to worsening diabetes (such as renal failure, previous myocardial infarction, retinopathy, signs or symptoms of severe diabetic neuropathy or diabetic foot ulcers), severe osteoarthritis or as judged by the attending physician.
• Pregnant or breast-feeding women
• Persons who are unable to give signed informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Glycated haemoglobin HbA1c (∆HbA1c)	During 18 month	Mean change in glycated haemoglobin HbA1c (∆HbA1c)

Secondary Outcome Measures

Name	Time	Method
Health-related quality of life (∆ EQ-5D-5L)	During 18 months	Mean change in health-related quality of life (∆ EQ-5D-5L). The EuroQol 5-Dimension 5-Level Health Questionnaire (EQ-5D-5L) scale measures health-related quality of life, including five dimensions, each rated on five levels. Utility scores range from -0.59 (negative scores are considered as worse than death) to 1.000 (perfect health), with higher scores indicating better health.
Cost-effectiveness analysis	At 12 and 18 months	Cost-effectiveness analysis (∆HbA1c; costs assessed from the payer's point of view)
Diabetes self-care behaviours measured by the Diabetes Intention, Attitude, and Behavior Questionnaire (∆ DIAB-Q)	During 18 months	Mean change in intention to adopt diabetes self-care behaviours (∆ DIAB-Q). Scores range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better outcomes and less impact of diabetes on daily life.
Fat/lean body mass (∆ body composition)	During 18 months	Mean change in body fat/lean body mass (∆ body composition)