CClinicalTrials.gg
Not yet recruitingNCT06774950Alliance DT2Updated Jan 14, 2025

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

An interventional study of Physician-patient quality circle in Diabetes Mellitus, Type 2, sponsored by Réseau de soins Delta. Not yet recruiting. Open to participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-01-14.

Sponsored by Réseau de soins Delta · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 2 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
154
Allocation
Randomized
Ages
40 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's planned enrollment of 154 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Réseau de soins Delta is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
154 participants (estimated)

Study arms

  • No intervention
    Usual care

    Usual care

  • Experimental
    Intervention arm

    Behavioral: Physician-patient quality circle

Interventions

  • BehavioralPhysician-patient quality circle

    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

06

What researchers measure

Primary outcomes

  1. Glycated haemoglobin HbA1c (∆HbA1c)

    Mean change in glycated haemoglobin HbA1c (∆HbA1c)

    Time frame: During 18 month

Secondary outcomes

  1. 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.

    Time frame: During 18 months

  2. 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.

    Time frame: During 18 months

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

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

    Time frame: During 18 months

  4. Cost-effectiveness analysis

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

    Time frame: At 12 and 18 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided — Depends on authorities

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06774950
Lead sponsor
Réseau de soins Delta
Collaborators
University of St. Gallen - School of Medicine
Responsible party
Minette-Joëlle Zeukeng (Principal Investigator, Réseau de soins Delta) — Principal investigator
First posted
Jan 14, 2025
Start date
Mar 1, 2025 (estimated)
Primary completion
Aug 1, 2025 (estimated)
Completion
Mar 1, 2027 (estimated)
Last update
Jan 14, 2025

Study contacts

Minette-Joëlle MJ Zeukeng, PharmD, PhD, FPH, RPh
Contact
minette.zeukeng@reseau-delta.ch
0041798921981
Philippe Schaller, MD, MPH, FMH
Contact
philippe.schaller@reseau-delta.ch
0041796525116
Alexander Geissler, PhD
study chair · University of St. Gallen - School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion