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NCT Number: NCT06774950

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physician-patient quality circle

Behavioral

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

Primary outcomes

  1. Glycated haemoglobin HbA1c (∆HbA1c)

    Time frame: During 18 month

    Mean change in glycated haemoglobin HbA1c (∆HbA1c)

Secondary outcomes

  1. Health-related quality of life (∆ EQ-5D-5L)

    Time frame: 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.

  2. Diabetes self-care behaviours measured by the Diabetes Intention, Attitude, and Behavior Questionnaire (∆ DIAB-Q)

    Time frame: 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.

  3. Fat/lean body mass (∆ body composition)

    Time frame: During 18 months

    Mean change in body fat/lean body mass (∆ body composition)

  4. Cost-effectiveness analysis

    Time frame: At 12 and 18 months

    Cost-effectiveness analysis (∆HbA1c; costs assessed from the payer's point of view)

Study contacts

Contact information is provided by the study sponsor or research team.

Minette-Joëlle MJ Zeukeng, PharmD, PhD, FPH, RPh

CONTACT

[email protected]

0041798921981

Philippe Schaller, MD, MPH, FMH

CONTACT

[email protected]

0041796525116

Sponsors and collaborators

Lead sponsor

Réseau de soins Delta

Other

Collaborators

  • University of St.Gallen

Registry information

Official study title

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

Acronym: Alliance DT2

Important dates

Study start
2025
Primary completion
2025
Study completion
2027
First posted
Jan 14, 2025
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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