Value-based Care in Type 2 Diabetes (Enhancing T2D Care) (Alliance DT2)

Améliorer La Prise En Soins Et La Qualité De Vie Des Patients Diabétiques De Type 2 (Alliance DT2)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: Physician-patient quality circle

• Study Type: Interventional
• Enrollment (Estimated): 154
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Minette-Joëlle MJ Zeukeng, PharmD, PhD, FPH, RPh; Phone Number: 0041798921981; Email: minette.zeukeng@reseau-delta.ch
• Study Contact Backup: Name: Philippe Schaller, MD, MPH, FMH; Phone Number: 0041796525116; Email: philippe.schaller@reseau-delta.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm	Behavioral: Physician-patient quality circle; Intervention: (To be compared with standard care); Interprofessionnal meeting per neighbourhood: (beforehand) Therapeutic patient education (TPE) training for healthcare professionals; Physician-patient quality circle t0 Group sessions (n= 3 to 6 patients) with doctor and therapeutic patient education specialist Clinical measurements - CM (incl. HbA1c, body composition, blood pressure). PROM evaluation questionnaires (EQ5D&DIABQ); Development of individualised T2D programme: with case manager; Quarterly follow-up: t3, t6, t9 months PROM follow-up (DIABQ&PHQ9) +CM.; Evaluation of experience: t12 & t18 months PREM&PROM evaluation questionnaire +CM
No Intervention: Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycated haemoglobin HbA1c (∆HbA1c)	Mean change in glycated haemoglobin HbA1c (∆HbA1c)	During 18 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related quality of life (∆ EQ-5D-5L)	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.	During 18 months
Diabetes self-care behaviours measured by the Diabetes Intention, Attitude, and Behavior Questionnaire (∆ DIAB-Q)	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.	During 18 months
Fat/lean body mass (∆ body composition)	Mean change in body fat/lean body mass (∆ body composition)	During 18 months
Cost-effectiveness analysis	Cost-effectiveness analysis (∆HbA1c; costs assessed from the payer's point of view)	At 12 and 18 months

Collaborators and Investigators

• Sponsor: Réseau de soins Delta
• Collaborators: University of St. Gallen - School of Medicine
• Investigators: Study Chair: Alexander Geissler, PhD, University of St. Gallen - School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: December 10, 2024
• First Submitted That Met QC Criteria: January 13, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 13, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2024-01350; SNCTP000006190 (Other Identifier: Swiss National Clinical Trials Portal)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Depends on authorities

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No