Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2025-12-25 @ 2:50 PM
Study NCT ID:
NCT06774950
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-14
First Post:
2024-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Value-based Care in Type 2 Diabetes (Enhancing T2D Care)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The clinical trial has a complex trial design. The clinical trial is not a Decentralized Clinical Trials-DCT, nor has decentralized elements'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 154}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-13', 'studyFirstSubmitDate': '2024-12-10', 'studyFirstSubmitQcDate': '2025-01-13', 'lastUpdatePostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycated haemoglobin HbA1c (∆HbA1c)', 'timeFrame': 'During 18 month', 'description': 'Mean change in glycated haemoglobin HbA1c (∆HbA1c)'}], 'secondaryOutcomes': [{'measure': 'Health-related quality of life (∆ EQ-5D-5L)', 'timeFrame': 'During 18 months', 'description': '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.'}, {'measure': 'Diabetes self-care behaviours measured by the Diabetes Intention, Attitude, and Behavior Questionnaire (∆ DIAB-Q)', 'timeFrame': 'During 18 months', 'description': '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.'}, {'measure': 'Fat/lean body mass (∆ body composition)', 'timeFrame': 'During 18 months', 'description': 'Mean change in body fat/lean body mass (∆ body composition)'}, {'measure': 'Cost-effectiveness analysis', 'timeFrame': 'At 12 and 18 months', 'description': "Cost-effectiveness analysis (∆HbA1c; costs assessed from the payer's point of view)"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with newly diagnosed type 2 diabetes (less than 10 years)\n* Age (between 40 and 65)\n\nExclusion Criteria:\n\n* 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.\n* Pregnant or breast-feeding women\n* Persons who are unable to give signed informed consent'}, 'identificationModule': {'nctId': 'NCT06774950', 'acronym': 'Alliance DT2', 'briefTitle': 'Value-based Care in Type 2 Diabetes (Enhancing T2D Care)', 'organization': {'class': 'OTHER', 'fullName': 'Réseau de soins Delta'}, 'officialTitle': 'Améliorer La Prise En Soins Et La Qualité De Vie Des Patients Diabétiques De Type 2 (Alliance DT2)', 'orgStudyIdInfo': {'id': '2024-01350'}, 'secondaryIdInfos': [{'id': 'SNCTP000006190', 'type': 'OTHER', 'domain': 'Swiss National Clinical Trials Portal'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Usual care'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention arm', 'interventionNames': ['Behavioral: Physician-patient quality circle']}], 'interventions': [{'name': 'Physician-patient quality circle', 'type': 'BEHAVIORAL', 'description': 'Intervention: (To be compared with standard care)\n\n1. Interprofessionnal meeting per neighbourhood: (beforehand) Therapeutic patient education (TPE) training for healthcare professionals\n2. 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)\n3. Development of individualised T2D programme: with case manager\n4. Quarterly follow-up: t3, t6, t9 months PROM follow-up (DIABQ\\&PHQ9) +CM.\n5. Evaluation of experience: t12 \\& t18 months PREM\\&PROM evaluation questionnaire +CM', 'armGroupLabels': ['Intervention arm']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Minette-Joëlle MJ Zeukeng, PharmD, PhD, FPH, RPh', 'role': 'CONTACT', 'email': 'minette.zeukeng@reseau-delta.ch', 'phone': '0041798921981'}, {'name': 'Philippe Schaller, MD, MPH, FMH', 'role': 'CONTACT', 'email': 'philippe.schaller@reseau-delta.ch', 'phone': '0041796525116'}], 'overallOfficials': [{'name': 'Alexander Geissler, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of St.Gallen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Depends on authorities'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Réseau de soins Delta', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of St.Gallen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Minette-Joëlle Zeukeng', 'investigatorAffiliation': 'Réseau de soins Delta'}}}}