Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-28 @ 4:35 AM
Study NCT ID:
NCT00937703
Status:
COMPLETED
Last Update Posted:
2013-12-13
First Post:
2009-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicentric Evaluation of Two Telematics Systems in Type 2 Diabetic Patients in Failure of Oral Treatment and Having to Start Treatment by Basal Insulin
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': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-12', 'studyFirstSubmitDate': '2009-07-10', 'studyFirstSubmitQcDate': '2009-07-10', 'lastUpdatePostDateStruct': {'date': '2013-12-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison HbA1c means of the 2 groups profiting from a telemonitoring system compared to the reference group.', 'timeFrame': 'To T4 months'}], 'secondaryOutcomes': [{'measure': 'Comparison of absolute HbA1c difference', 'timeFrame': 'T0-T4 months'}, {'measure': 'Comparison of evolution of HbA1c', 'timeFrame': 'T0 and T4 months'}, {'measure': 'Comparison of percentage of patients reaching HbA1c < 7.0% in 4 months', 'timeFrame': 'T0 and T4 months'}, {'measure': 'Comparison of percentage of patients within the objective glycemic (the last 3 days Jeun Glycemia average with between 0.73 and 1.08 g/l) at the end of the study, and the average time allowing to achieve this goal', 'timeFrame': 'T0 and T4 months'}, {'measure': 'Comparison of the average jeun glycemia the 14 days previous the visit in 4 months', 'timeFrame': 'T4 months'}, {'measure': 'Comparison of the frequency of benign hypoglycemias, symptomatic or not, night and severe throughout study', 'timeFrame': 'study period'}, {'measure': 'Comparison of the evolution of the weight', 'timeFrame': 'T0 and T4 months'}, {'measure': 'Comparison of evolution of the quality of life at the beginning and at the end of the study (the scale of quality of life DHP as well as the items of dimension Satisfaction of the DQOL)', 'timeFrame': 'T0 and T4 months'}, {'measure': 'Comparison of the time spent by physicians with patients during visit (either face to face visits or phone call visit);', 'timeFrame': 'study period'}, {'measure': 'Comparison of the satisfaction of the patients and physicians with the system and willingness to carry on the use of the system in routine care', 'timeFrame': '4 months'}, {'measure': 'Effective number of patients carrying on the use of the system in routine care, at their own expense and in agreement with their physician', 'timeFrame': '4 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['TYPE 2 DIABETES']}, 'descriptionModule': {'briefSummary': 'TELEDIAB-2 is a national, multicenter, controlled, randomised trial. The primary objective of the study is to show that during the initiation of a basal insulin treatment , a computerized decision-making system of adaptation of the insulin, coupled to a distance follow-up (thanks to PDAphone or an interactive vocal server (IVS)), is able to improve metabolic control at the end of 4 mouths as compared with conventional care.\n\nMain judgment criteria: comparison of HbA1c means of the 2 groups profiting from a telemonitoring system compared to the reference group at 4 months.', 'detailedDescription': 'Secondary objectives :\n\n1. \\- To compare the 2 methods of telemonitoring employed.\n2. \\- To evaluate the speed of the glycemic attack of the objective to the rising, according to the method of follow-up employed.\n3. \\- To evaluate the satisfaction of the patients and the doctors with respect to systems of telemonitoring, and improvement of the quality of life (DQOL).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Type 2 diabetes since more than 3 years and claiming a strict balance glycemic;\n* Patients treated since at least 3 months, by metformin and secreting insulinic (KNOWN or glinide);\n* Patients uncontrolled with HbA1c ≥ 7.5% and \\< 10% at the inclusion.\n* BMI \\< 40 ;\n* Patients requiring a insulin treatment\n* Patients agree to start a slow insulin treatment\n* Patients already practising the glycemic self-monitoring or agree to learn it and practise it;\n* Patients able to include/understand operation and to use the PDA-phone and/or the SVI;\n* Patient not taking part in another biomedical research study\n* Patients agree to carry out at least 2 finger sticks per day;\n* More than 18 years, there is no higher age limit.\n\nExclusion Criteria:\n\n* Patients introducing any evolutionary pathology associated and not stabilized, exhibitor with an uncontrolled diabetes during the year to come;\n* Patients in a situation which justifies of a clinical follow-up diabetologic more frequent than that (quarterly) envisaged by the study\n* Patients requiring a transitory passage to insulin;\n* Patients needing a hospitalization for the adaptation of insulin doses;\n* Patients presenting a cardiologic event\n* Patients presenting a hemoglobinopathy interfering with the proportioning of HbA1c;\n* Patients suffering from drug-addiction, alcoholism or psychological troubles\n* Type 1 or secondary diabetes\n* Patients who don't need strict metabolic objectives;\n* Pregnant or parturient patients\n* person with no freedom."}, 'identificationModule': {'nctId': 'NCT00937703', 'acronym': 'TELEDIAB-2', 'briefTitle': 'Multicentric Evaluation of Two Telematics Systems in Type 2 Diabetic Patients in Failure of Oral Treatment and Having to Start Treatment by Basal Insulin', 'organization': {'class': 'OTHER', 'fullName': "Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète"}, 'officialTitle': 'Multicentric Evaluation of Two Telematics Systems (PDA Phone and IVS)in Type 2 Diabetics Patients in Failure of Oral Treatment and Having to Start a Treatment by Basal Insulin, Compared to a Conventional Care. National, Multicentric, Comparative Randomized Study', 'orgStudyIdInfo': {'id': '2008-A00270-55'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Group1: Control group', 'description': 'face to face visit à T4mounths', 'interventionNames': ['Device: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group2: IVS Group', 'description': 'face to face visit at T4mounths plus telephone visits each 2 weeks', 'interventionNames': ['Device: IVS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group3: PDAphone group', 'description': 'PDA system face to face visit at T4mounths plus telephone visits each 2 weeks', 'interventionNames': ['Device: PDAphone']}], 'interventions': [{'name': 'placebo', 'type': 'DEVICE', 'description': 'paper support for glycaemia face to face visit at T4mounths', 'armGroupLabels': ['Group1: Control group']}, {'name': 'IVS', 'type': 'DEVICE', 'description': 'patients transmit their glycaemia to the IVS, which advises them the insulin amount recommended by their physician in this situation.\n\nFace to face visit at T4mounths plus telephone visits each 2 weeks.', 'armGroupLabels': ['Group2: IVS Group']}, {'name': 'PDAphone', 'type': 'DEVICE', 'description': 'Patients will receive PDA phone system. They will hace face to face visit at T4mounths and telephone visits each 2 weeks', 'armGroupLabels': ['Group3: PDAphone group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13100', 'city': 'Aix-en-Provence', 'country': 'France', 'facility': 'CH Aix en Provence', 'geoPoint': {'lat': 43.5283, 'lon': 5.44973}}, {'zip': '61000', 'city': 'Alençon', 'country': 'France', 'facility': 'Centre Hospitalier Intercommunal Alençon-Mamers', 'geoPoint': {'lat': 48.43476, 'lon': 0.09311}}, {'zip': '84000', 'city': 'Avignon', 'country': 'France', 'facility': 'CH Avignon', 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'zip': '90016', 'city': 'Belfort', 'country': 'France', 'facility': 'Centre Hospitalier de Belfort Montbéliard', 'geoPoint': {'lat': 47.64218, 'lon': 6.85385}}, {'zip': '25030', 'city': 'Besançon', 'country': 'France', 'facility': 'CHU Jean Minjoz', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '14000', 'city': 'Caen', 'country': 'France', 'facility': 'CHU de Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '63011', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Hôpital Gabriel Montpied', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '91106', 'city': 'Corbeil-Essonnes', 'country': 'France', 'facility': 'CH sud francilien', 'geoPoint': {'lat': 48.60603, 'lon': 2.48757}}, {'zip': '28100', 'city': 'Dreux', 'country': 'France', 'facility': 'CH de Dreux', 'geoPoint': {'lat': 48.73649, 'lon': 1.36566}}, {'zip': '97261', 'city': 'Fort de France', 'country': 'France', 'facility': 'CHU Pierre Zobda-Quitman'}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'University Hospital Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '17000', 'city': 'La Rochelle', 'country': 'France', 'facility': 'CH La Rochelle', 'geoPoint': {'lat': 46.16308, 'lon': -1.15222}}, {'zip': '94270', 'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'facility': 'CHU de Bicêtre', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '13000', 'city': 'Marseille', 'country': 'France', 'facility': 'CHU Marseille-Hôpital Nord', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13274', 'city': 'Marseille', 'country': 'France', 'facility': 'CHU Marseille Hôpitaux Sud', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '45207', 'city': 'Montagis', 'country': 'France', 'facility': "CH de l'Agglomération Montargoise"}, {'zip': '54201', 'city': 'Nancy', 'country': 'France', 'facility': "CHU Hôpital Jeanne d'Arc", 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '92000', 'city': 'Nanterre', 'country': 'France', 'facility': 'CH Nanterre', 'geoPoint': {'lat': 48.89198, 'lon': 2.20675}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'CHU Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU de Nimes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital COCHIN', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '33604', 'city': 'Pessac', 'country': 'France', 'facility': 'Hopital Haut Leveque', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '86000', 'city': 'Poitiers', 'country': 'France', 'facility': 'CHU de Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '35056', 'city': 'Rennes', 'country': 'France', 'facility': 'CHU Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '42023', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU de Saint Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'zip': '94160', 'city': 'Saint-Mandé', 'country': 'France', 'facility': 'Hôpital Bégin', 'geoPoint': {'lat': 48.83864, 'lon': 2.41579}}, {'zip': '67000', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Centre Hospitalier Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '59322', 'city': 'Valenciennes', 'country': 'France', 'facility': 'Ch Valenciennes', 'geoPoint': {'lat': 50.35909, 'lon': 3.52506}}], 'overallOfficials': [{'name': 'Guillaume CHARPENTIER, MD', 'role': 'STUDY_CHAIR', 'affiliation': "Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète"}, {'name': 'Pierre Yves BENHAMOU, MD PHD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital, Grenoble'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète", 'class': 'OTHER'}, 'collaborators': [{'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}