Evidence map›Paper›PMID 41437100›Full record

ArticleTrials2025

Enhancing type 2 diabetes care by an individualized and group-based therapeutic patient education program: study protocol for a cluster randomized trial.

David Ehlig, Maxime Sapin, Minette-Joëlle Zeukeng, Justus Vogel, Vincent Barthassat, Benoit Favre, Henrique DaCosta, Ksenia Tugay, Stephane Coendoz-Carron, David Bumann and 3 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06774950 (Améliorer La Prise En Soins Et La Qualité De Vie Des Patients Diabétiques De Type 2), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06774950 nanot yet recruitingnot on this map

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

TypeinterventionalSponsorRéseau de soins DeltaRan2025 to 2027Enrolled154ConditionsDiabetes Mellitus, Type 2ArmsPhysician-patient quality circle
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

David EhligChair of Health Economics, Policy and Management, School of Medicine, University of St. Gallen, St. Gallen, Switzerland. david.ehlig@unisg.ch.ORCID http://orcid.org/0000-0002-7092-7480
Maxime SapinChair of Health Economics, Policy and Management, School of Medicine, University of St. Gallen, St. Gallen, Switzerland.ORCID http://orcid.org/0009-0009-5412-6227
Minette-Joëlle ZeukengRéseau Delta, Petit-Lancy, Switzerland.ORCID http://orcid.org/0000-0001-9721-7289
Justus VogelChair of Health Economics, Policy and Management, School of Medicine, University of St. Gallen, St. Gallen, Switzerland.ORCID http://orcid.org/0000-0002-2605-8994
Vincent BarthassatRéseau Delta, Petit-Lancy, Switzerland.
Benoit FavreRéseau Delta, Petit-Lancy, Switzerland.
Henrique DaCostaSokle SA, Geneve, Switzerland.
Ksenia TugayGroupe Mutuel, Martigny, Switzerland.
Stephane Coendoz-CarronCommune de Savièse, Saviese, Switzerland.
David Bumann, Bern, Switzerland.
Joëlle CocletRéseau Delta, Petit-Lancy, Switzerland.
Philippe SchallerRéseau Delta, Petit-Lancy, Switzerland.ORCID http://orcid.org/0000-0003-3352-5244
Alexander GeisslerChair of Health Economics, Policy and Management, School of Medicine, University of St. Gallen, St. Gallen, Switzerland.ORCID http://orcid.org/0000-0002-7445-2929

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundType 2 diabetes (T2D) presents a significant challenge to health systems and its prevalence is projected to increase. T2D is significantly influenced by lifestyle factors, including diet and physical activity. This makes therapeutic patient education (TPE) a pivotal component of T2D treatment strategies. While in some countries, like Germany and the UK, TPE elements like physician counselling regarding lifestyle changes (e.g., nutrition, smoking, exercise) and participation in diabetes education courses are part of structured nationwide disease management programs; in Switzerland, TPE elements are rarely part of the standard of care protocols. Our goal is to evaluate whether an interdisciplinary and individualized T2D program including TPE elements improves patients' health outcomes.

methodsThe study is a multi-center cluster randomized controlled trial in the canton of Geneva in Western Switzerland. We aim to include a minimum of 154 recently diagnosed T2D patients from around 30 primary care physician (PCP) practices. Practices are randomized with a 1:1 patient allocation ratio to either intervention or control group using covariate constrained randomization. The intervention lasts 12 months with a 6-month follow-up and consists of two steps. First, PCPs in the intervention group and associated healthcare professionals (e.g., dieticians, physical therapists) are trained in interprofessional group sessions on TPE elements by specialists. Second, patients follow an individualized treatment plan which is designed within an initial quality circle with their PCP, other healthcare professionals, a TPE specialist, a dedicated study manager, and other patients. The treatment plan is accompanied by regular patient-reported outcome measure (PROM) collections, which are discussed in patients' regular PCP visits. Patients in the control group follow standard of care. Primary endpoint is the 12 months mean change in HbA1c levels, secondary endpoints are the 18 months mean change in HbA1c levels, the 12 and 18 months mean changes in patient-reported outcomes (EQ-5D-5L, DIAB-Q), mean changes in medical outcomes (blood pressure, body composition, medication intake), and patient experience. We further evaluate cost-effectiveness from the payer perspective. DISCUSSION: A positive evaluation of the study can inform a wider roll-out of the T2D program within Switzerland and be a cornerstone for better patient health outcomes for T2D patients.

trial registrationClinicalTrials.gov: NCT06774950. Registered on 14 January 2025.

Indexed as

Diabetes Mellitus, Type 2Patient Education as TopicPrecision MedicineRisk Reduction BehaviorCost-Benefit AnalysisGlycated HemoglobinHealth Knowledge, Attitudes, PracticeHealthy LifestyleHumansMulticenter Studies as TopicPatient Care TeamRandomized Controlled Trials as TopicSwitzerlandTime FactorsTreatment OutcomeGlycated Hemoglobinhemoglobin A1c protein, humanChronic disease managementCost-effectivenessHealth-related quality of lifePatient therapeutic educationPROMsType 2 diabetesValue-based healthcare

Identifiers

PMID41437100
PMCPMC12723846

What Socratic holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.