Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-27 @ 11:02 PM
Study NCT ID:
NCT01223560
Status:
COMPLETED
Last Update Posted:
2010-10-19
First Post:
2010-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Collection of Information-Rich Type 1 Diabetes Data
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061267', 'term': 'Insulin Aspart'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D002241', 'term': 'Carbohydrates'}], 'ancestors': [{'id': 'D061266', 'term': 'Insulin, Short-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-18', 'studyFirstSubmitDate': '2010-10-18', 'studyFirstSubmitQcDate': '2010-10-18', 'lastUpdatePostDateStruct': {'date': '2010-10-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Artificial pancreas', 'Model predictive control', 'Virtual patient'], 'conditions': ['Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': 'The aim of this clinical study was to obtain type 1 diabetes data to identify models for glucose prediction and control and to construct a physiological pharmaco-kinetic/pharmaco-dynamic computer model of a type 1 diabetic person.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diabetes duration \\> 5 years\n* HbA1c \\< or = 7.2%\n* CSII treated for \\> 3 months\n* Capable of being moderately, physically active for 20 minutes\n\nExclusion Criteria:\n\n* symptoms of diabetic late complications except simplex retinopathy\n* pregnancy or nursing'}, 'identificationModule': {'nctId': 'NCT01223560', 'briefTitle': 'Collection of Information-Rich Type 1 Diabetes Data', 'organization': {'class': 'OTHER', 'fullName': 'Hvidovre University Hospital'}, 'orgStudyIdInfo': {'id': 'DiaCon Study 01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Insulin Aspart', 'type': 'DRUG', 'description': 'Insulin bolus with and without carbohydrate intake.'}, {'name': 'Exercise', 'type': 'OTHER', 'description': 'Exercise on tread mill'}, {'name': 'Carbohydrate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Carbohydrate intake'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'Hvidovre University Hospital', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hvidovre University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Danish Council for Strategic Research', 'class': 'OTHER'}, {'name': 'Technical University of Denmark', 'class': 'OTHER'}, {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Signe Schmidt, MD', 'oldOrganization': 'Hvidovre University Hospital'}}}}