NCT06774950

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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
154

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
10mo left

Started Mar 2025

Typical duration for not_applicable diabetes-mellitus-type-2

Status
not yet recruiting

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 Progress59%
Mar 2025Mar 2027

First Submitted

Initial submission to the registry

December 10, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 14, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Expected
Last Updated

January 14, 2025

Status Verified

January 1, 2025

Enrollment Period

5 months

First QC Date

December 10, 2024

Last Update Submit

January 13, 2025

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Glycated haemoglobin HbA1c (∆HbA1c)

    Mean change in glycated haemoglobin HbA1c (∆HbA1c)

    During 18 month

Secondary Outcomes (4)

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

    During 18 months

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

    During 18 months

  • Fat/lean body mass (∆ body composition)

    During 18 months

  • Cost-effectiveness analysis

    At 12 and 18 months

Study Arms (2)

Usual care

NO INTERVENTION

Usual care

Intervention arm

EXPERIMENTAL
Behavioral: Physician-patient quality circle

Interventions

Physician-patient quality circleBEHAVIORAL

Intervention: (To be compared with standard care) 1. Interprofessionnal meeting per neighbourhood: (beforehand) Therapeutic patient education (TPE) training for healthcare professionals 2. 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) 3. Development of individualised T2D programme: with case manager 4. Quarterly follow-up: t3, t6, t9 months PROM follow-up (DIABQ\&PHQ9) +CM. 5. Evaluation of experience: t12 \& t18 months PREM\&PROM evaluation questionnaire +CM

Intervention arm

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ehlig D, Sapin M, Zeukeng MJ, Vogel J, Barthassat V, Favre B, DaCosta H, Tugay K, Coendoz-Carron S, Bumann D, Coclet J, Schaller P, Geissler A. Enhancing type 2 diabetes care by an individualized and group-based therapeutic patient education program: study protocol for a cluster randomized trial. Trials. 2025 Dec 23;26(1):577. doi: 10.1186/s13063-025-09302-x.

    PMID: 41437100DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Alexander Geissler, PhD

    University of St.Gallen

    STUDY CHAIR

Central Study Contacts

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

CONTACT

0041798921981minette.zeukeng@reseau-delta.ch

Philippe Schaller, MD, MPH, FMH

CONTACT

0041796525116philippe.schaller@reseau-delta.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The clinical trial has a complex trial design. The clinical trial is not a Decentralized Clinical Trials-DCT, nor has decentralized elements
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 10, 2024

First Posted

January 14, 2025

Study Start

March 1, 2025

Primary Completion

August 1, 2025

Study Completion (Estimated)

March 1, 2027

Last Updated

January 14, 2025

Record last verified: 2025-01