Ignite Creation Date:
2025-12-25 @ 12:57 AM
Ignite Modification Date:
2026-03-09 @ 12:19 AM
Study NCT ID:
NCT01569893
Status:
COMPLETED
Last Update Posted:
2015-10-28
First Post:
2012-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Life-Long Monitoring of Diabetes Mellitus in Veneto Region
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'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': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 598}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-27', 'studyFirstSubmitDate': '2012-03-30', 'studyFirstSubmitQcDate': '2012-03-30', 'lastUpdatePostDateStruct': {'date': '2015-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health related quality of life of the patients measured by the SF-36 version 2 questionnaire', 'timeFrame': 'At the entry point of intervention and at the end (12 months)'}, {'measure': 'Glycated hemoglobin (HbA1c) levels', 'timeFrame': 'At the entry point of intervention and at the end (12 months)'}], 'secondaryOutcomes': [{'measure': 'Number of hospitalisations.', 'timeFrame': '12 months'}, {'measure': 'Number of hospitalisations due to diabetes.', 'timeFrame': '12 months'}, {'measure': 'Bed days of care', 'timeFrame': '12 months'}, {'measure': 'Bed days of care due to diabetes.', 'timeFrame': '12 months'}, {'measure': 'Number of visits with specialists', 'timeFrame': '12 months'}, {'measure': 'Number of access to ER', 'timeFrame': '12 months'}, {'measure': 'Mental status measured through Hospital Anxiety and Depression Scale (HADS).', 'timeFrame': 'At the entry point of intervention and at the end (12 months)'}, {'measure': 'Number of visits with specialists in diabetic center', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Telemonitoring', 'Telemedicine', 'Diabetes mellitus'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.renewinghealth.eu', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'To evaluate whether patients with type 2 diabetes mellitus can be followed by simplified, centralized and large scale tele-monitoring of blood glucose levels, and whether this intervention produces health and economic benefits when introduced without major changes to the existing organization of a large treatment care center.', 'detailedDescription': 'The study is designed to evaluate the impact of telemonitoring on the management of Diabetes Mellitus compared with outpatient usual care. From a clinical point of view, the measurements of HbA1c will be taken to assess glycaemic control and the trial will allow to investigate how telemonitoring contributes to improve Diabetes mellitus patients health-related quality of life and reduct the access to hospital facilities (re-hospitalizations, bed-days, specialistic and ER visits) and the anxiety about health conditions. A cost-effectiveness and cost-utility analysis will be carried out in order to determine if and how telemonitoring helps to limit the healthcare expenditure. The evaluation will deal also with organizational changes and task shift due to telemonitoring introduction and patients and professionals perception towards the service.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of type 2 Diabetes\n* HbA1c \\> 53 mmol/mol (7.0 % according to NGSP)\n* Capability to use the devices provided\n* Being cognitively able to participate\n* Capability of filling in questionnaires in german or greek or italian language\n* Absence of severe comorbidity prevalent on diabetes with life expectancy \\< 12 months\n\nExclusion Criteria:\n\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT01569893', 'briefTitle': 'Life-Long Monitoring of Diabetes Mellitus in Veneto Region', 'organization': {'class': 'OTHER', 'fullName': 'Regione Veneto'}, 'officialTitle': 'RENEWING HEALTH - Large Scale Pilot in Veneto Region: Life-long Monitoring of Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'G. A. 250487 - Veneto WP8Cl2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Usual care: treatment as usual'}, {'type': 'EXPERIMENTAL', 'label': 'Self-monitoring for patients with Dibetes mellitus type 2', 'description': 'Self-monitoring for patients with Dibetes mellitus type 2', 'interventionNames': ['Other: Self-monitoring for patients with Dibetes mellitus']}], 'interventions': [{'name': 'Self-monitoring for patients with Dibetes mellitus', 'type': 'OTHER', 'description': 'Patients are equipped with a telemonitoring kit composed by a portable glucose meter and a gateway device for data transmission.\n\nThe patient can monitor his blood glucose level with a frequency set by the clinician in the personalised treatment plan. Data are transmitted to a regional eHealth centre where a group of operators keeps these information under control and alert the reference clinician in case of worsening of symptoms.', 'armGroupLabels': ['Self-monitoring for patients with Dibetes mellitus type 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36015', 'city': 'Schio', 'state': 'Vicenza', 'country': 'Italy', 'facility': '"De Lellis" Hospital - Diabetology-Endocrinology Department', 'geoPoint': {'lat': 45.71262, 'lon': 11.35671}}], 'overallOfficials': [{'name': 'Francesco Calcaterra, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Local Health Authority "Alto Vicentino" of Thiene (VI)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regione Veneto', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Commission', 'class': 'OTHER'}, {'name': 'Azienda ULSS 4 Alto Vicentino', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}