Diabetes Mellitus, Type 2Alliance DT2NCT06774950
Value-based Care in Type 2 Diabetes (Enhancing T2D Care)
A study testing Physician-patient quality circle in people with Diabetes Mellitus, Type 2, run by Réseau de soins Delta.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Physician-patient quality circle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with newly diagnosed type 2 diabetes (less than 10 years)
- Age (between 40 and 65)
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Minette-Joëlle MJ Zeukeng, PharmD, PhD, FPH, RPh contact
About this study
Official title: 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Physician-patient quality circle
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician-patient quality circleBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Usual care |
| Intervention arm | Experimental | Not described Receives: Behavioral: Physician-patient quality circle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated haemoglobin HbA1c (∆HbA1c)
Mean change in glycated haemoglobin HbA1c (∆HbA1c)
Measured: During 18 month
Secondary outcomes (4)
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.
Measured: 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.
Measured: During 18 months
Fat/lean body mass (∆ body composition)
Mean change in body fat/lean body mass (∆ body composition)
Measured: During 18 months
Cost-effectiveness analysis
Cost-effectiveness analysis (∆HbA1c; costs assessed from the payer's point of view)
Measured: At 12 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The clinical trial has a complex trial design. The clinical trial is not a Decentralized Clinical Trials-DCT, nor has decentralized elements
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Réseau de soins Delta
- Sponsor type
- University, hospital or other
- Collaborators
- University of St.Gallen
- Responsible party
- Principal investigator, Minette-Joëlle Zeukeng, Réseau de soins Delta
- Investigators
- Alexander Geissler, PhD, Study chair, University of St.Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06774950
- Sponsor's protocol ID
- 2024-01350
- Other IDs
- SNCTP000006190
- Acronym
- Alliance DT2
- Status last verified
- Jan 2025
- First submitted
- 10 Dec 2024
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Depends on authorities
Publications
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.
PubMed 41437100
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Améliorer La Prise En Soins Et La Qualité De Vie Des Patients Diabétiques De Type 2 (Alliance DT2)
- ClinicalTrials.gov ID
- NCT06774950
- Acronym / sponsor ID
- Alliance DT2 / 2024-01350
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Réseau de soins DeltaUniversity, hospital or other
- Collaborators
- University of St.Gallen
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 14 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- The clinical trial has a complex trial design. The clinical trial is not a Decentralized Clinical Trials-DCT, nor has decentralized elements
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Usual care |
| Intervention arm | Experimental | Behavioral: Physician-patient quality circle |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with newly diagnosed type 2 diabetes (less than 10 years)
- Age (between 40 and 65)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physician-patient quality circleIntervention: (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 | Behavioural | Intervention arm |
Primary outcome
Glycated haemoglobin HbA1c (∆HbA1c)
Time frame: During 18 month
Mean change in glycated haemoglobin HbA1c (∆HbA1c)
4 secondary outcomes
Health-related quality of life (∆ EQ-5D-5L)
Time frame: During 18 months
Diabetes self-care behaviours measured by the Diabetes Intention, Attitude, and Behavior Questionnaire (∆ DIAB-Q)
Time frame: During 18 months
Fat/lean body mass (∆ body composition)
Time frame: During 18 months
Cost-effectiveness analysis
Time frame: At 12 and 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Derived from this study: PubMed 41437100Ehlig 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.
- Individual participant dataSharing planned: Undecided. Depends on authorities
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Minette-Joëlle MJ Zeukeng, PharmD, PhD, FPH, RPh contact
Alexander Geissler, PhD study chair
University of St.Gallen
Questions about this trial
What is this clinical trial studying?
A study testing Physician-patient quality circle in people with Diabetes Mellitus, Type 2, run by Réseau de soins Delta.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Minette-Joëlle MJ Zeukeng, PharmD, PhD, FPH, RPh (0041798921981, minette.zeukeng@reseau-delta.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycated haemoglobin HbA1c (∆HbA1c) (time frame: During 18 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06774950, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.