Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-25 @ 6:59 PM
Study NCT ID:
NCT00629304
Status:
COMPLETED
Last Update Posted:
2012-02-09
First Post:
2008-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multicenter Assessment of the PDA-FIT System in Type 1 Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-08', 'studyFirstSubmitDate': '2008-02-26', 'studyFirstSubmitQcDate': '2008-03-04', 'lastUpdatePostDateStruct': {'date': '2012-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of HbA1c mean between the 3 groups', 'timeFrame': 'at 6 months'}], 'secondaryOutcomes': [{'measure': 'Absolute HbA1c differences (M0-M6)', 'timeFrame': 'inclusion and M6'}, {'measure': 'HbA1c changes at M0, M3 and M6', 'timeFrame': 'inclusion, M3 and M6'}, {'measure': 'Percentage of patients reaching HbA1c <7.5% at 6 months', 'timeFrame': '6 months'}, {'measure': 'Mean of blood glucose values as provided by glucose meters during the 14 days prior to inclusion and prior to the 6 months-visit', 'timeFrame': '14 days prior to inclusion and prior to M6'}, {'measure': 'Frequency of severe hypoglycaemic episodes and ketoacidosis episodes during the study period', 'timeFrame': 'study period'}, {'measure': 'Frequency of symptomatic benign hypoglycaemic episodes during the week prior to inclusion and prior to the 6 months-visit', 'timeFrame': 'week before inclusion and prior to M6'}, {'measure': '8-point blood glucose profiles at inclusion and 6 months', 'timeFrame': 'inclusion and M6'}, {'measure': 'Quality of life at inclusion and 6 months, using the DHP scale and the Satisfaction item of the DQOL questionnaire', 'timeFrame': 'inclusion and M6'}, {'measure': 'Improvement in diabetes care, as assessed by the change in blood glucose testing frequency, reflected by the glucose meter memory', 'timeFrame': 'study period'}, {'measure': 'Time spent by physicians with patients during visits (either face to face visits or phone call visits) and time spent by patients during transport, waiting time and lost working time', 'timeFrame': 'study period'}, {'measure': 'Satisfaction of patients and physicians with the system and willingness to carry on the use of the system in routine care', 'timeFrame': '6 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': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['type 1 diabetes', 'PDA phone (Personal Digital Assistant)', 'HbA1c'], 'conditions': ['Type 1 Diabetes']}, 'referencesModule': {'references': [{'pmid': '21266648', 'type': 'DERIVED', 'citation': 'Charpentier G, Benhamou PY, Dardari D, Clergeot A, Franc S, Schaepelynck-Belicar P, Catargi B, Melki V, Chaillous L, Farret A, Bosson JL, Penfornis A; TeleDiab Study Group. The Diabeo software enabling individualized insulin dose adjustments combined with telemedicine support improves HbA1c in poorly controlled type 1 diabetic patients: a 6-month, randomized, open-label, parallel-group, multicenter trial (TeleDiab 1 Study). Diabetes Care. 2011 Mar;34(3):533-9. doi: 10.2337/dc10-1259. Epub 2011 Jan 25.'}]}, 'descriptionModule': {'briefSummary': 'TELEDIAB-1 is a national, multicenter, controlled, randomised trial. The Primary objective of the TELEDIAB-1 study is to demonstrate that the PDA-FIT system (PDA-Phone and/or telemonitoring) is able to improve metabolic control of chronically uncontrolled type 1 diabetic patients, despite intensive insulin therapy (multiple daily injections with basal-bolus insulin or insulin pump), as compared with conventional care.\n\nMain judgment criteria: comparison of HbA1c means between the 3 groups at 6 months', 'detailedDescription': 'Secondary Objectives :\n\n1. To assess the improvement of blood glucose control and quality of life in patients using the PDA-FIT system\n2. To assess the improvement in diabetes care provided by the use of the PDA-FIT system\n3. Satisfaction of patients and physicians towards the PDA-FIT system'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* type 1 diabetes mellitus for ≥ 12 months or more (including C-peptide negative secondary diabetes)\n* age \\> 18 y.o.\n* intensive insulin basal-bolus therapy for ≥ 6 months. At inclusion, patients should be treated, either with a combination of a basal, long-acting insulin and insulin rapid analog before each meal, or with rapid insulin analog delivered with a pump\n* chronically uncontrolled diabetes with HbA1c ≥ 8 % during the past 12 months and at inclusion\n\nExclusion Criteria:\n\n* patient with unstable associated evolutive pathology\n* patient who need a more frequent diabetic follow up (than in the protocol)\n* patient with a education teaching within the 3 months before inclusion\n* patient with a hemoglobinopathy\n* patient with toxicomania, alcoholism or psychological troubles\n* type 2 diabetes patients\n* patient who don't need strict metabolic objectives\n* pregnant or parturient women\n* person with no freedom (prisoner)"}, 'identificationModule': {'nctId': 'NCT00629304', 'acronym': 'TELEDIAB-1', 'briefTitle': 'Multicenter Assessment of the PDA-FIT System in Type 1 Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': "Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète"}, 'officialTitle': 'Multicenter Assessment of the PDA-FIT System in Type 1 Diabetic Patients With Chronic Failure of Intensive Insulin Therapy and Conventional Care. The TELEDIAB-1 STUDY', 'orgStudyIdInfo': {'id': 'DCIC 07 08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'description': 'standard visit at 3 and 6 months', 'interventionNames': ['Device: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'PDA-FIT system + standard visit at 3 and 6 months', 'interventionNames': ['Device: VISITS + PDA-FIT system']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'PDA-FIT system + 12 telephone visits + standard visit at 6 months', 'interventionNames': ['Device: PDA-FIT System + telephone follow-up']}], 'interventions': [{'name': 'placebo', 'type': 'DEVICE', 'otherNames': ['paper support for glycemia', 'face to face visits at 3 and 6 months', 'without PDA-FIT system'], 'description': 'Patients will have face to face visits at 3 and 6 months and no PDA-FIT system. Patients will record glycemia on paper support.', 'armGroupLabels': ['1']}, {'name': 'VISITS + PDA-FIT system', 'type': 'DEVICE', 'otherNames': ['face to face visits at 3 and 6 months', 'PDA-FIT system'], 'description': 'patients will have face to face visits at 3 and 6 months + PDA-FIT system', 'armGroupLabels': ['2']}, {'name': 'PDA-FIT System + telephone follow-up', 'type': 'DEVICE', 'otherNames': ['face to face visit at 6 months', 'telephone visits each 2 weeks', 'PDA-FIT system'], 'description': 'patients will received PDA-FIT system + a telephone follow up (12 phone calls) and a face to face visit at 6 months', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90016', 'city': 'Belfort', 'state': 'Belfort', 'country': 'France', 'facility': 'Centre Hospitalier de Belfort Montbéliard', 'geoPoint': {'lat': 47.64218, 'lon': 6.85385}}, {'zip': '25030', 'city': 'Besançon', 'state': 'Besancon', 'country': 'France', 'facility': 'CHU Jean Minjoz', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '91100', 'city': 'Corbeil-Essonnes', 'state': 'Corbeil Essonnes', 'country': 'France', 'facility': 'CH SUD Francilien', 'geoPoint': {'lat': 48.60603, 'lon': 2.48757}}, {'zip': '38043', 'city': 'Grenoble', 'state': 'Grenoble', 'country': 'France', 'facility': 'University Hospital Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '59037', 'city': 'Lille', 'state': 'Lille', 'country': 'France', 'facility': 'CHRU Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69003', 'city': 'Lyon', 'state': 'Lyon', 'country': 'France', 'facility': 'Hopital Edouard Herriot', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13274', 'city': 'Marseille', 'state': 'Marseille', 'country': 'France', 'facility': 'CHU Marseille Hôpitaux Sud', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34295', 'city': 'Montpellier', 'state': 'Montpellier', 'country': 'France', 'facility': 'Chu Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '54201', 'city': 'Nancy', 'state': 'Nancy', 'country': 'France', 'facility': "CHU Hôpital Jeanne d'Arc", 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '44093', 'city': 'Nantes', 'state': 'Nantes', 'country': 'France', 'facility': 'CHU Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75004', 'city': 'Paris', 'state': 'Paris', 'country': 'France', 'facility': 'Hopital Hotel Dieu', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'state': 'Paris', 'country': 'France', 'facility': 'Hopital COCHIN', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75475', 'city': 'Paris', 'state': 'Paris', 'country': 'France', 'facility': 'HOPITAL Saint Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '33604', 'city': 'Pessac', 'state': 'Pessac', 'country': 'France', 'facility': 'Hopital Haut Leveque', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '35056', 'city': 'Rennes', 'state': 'Rennes', 'country': 'France', 'facility': 'CHU Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '42055', 'city': 'Saint-Etienne', 'state': 'Saint Etienne', 'country': 'France', 'facility': 'Hopital Bellevue', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'zip': '67000', 'city': 'Strasbourg', 'state': 'Strasbourg', 'country': 'France', 'facility': 'Centre Hospitalier Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31403', 'city': 'Toulouse', 'state': 'Toulouse', 'country': 'France', 'facility': 'CHU Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'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': 'University Hospital, Grenoble', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}