Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2026-01-02 @ 1:54 AM
Study NCT ID:
NCT02190669
Status:
COMPLETED
Last Update Posted:
2014-11-13
First Post:
2014-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise and Diabetes - an Observational Study of Exercise and Blood Glucose Control
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-12', 'studyFirstSubmitDate': '2014-07-11', 'studyFirstSubmitQcDate': '2014-07-14', 'lastUpdatePostDateStruct': {'date': '2014-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Document the glycemic response of individuals without diabetes and with type 1 or type 2 diabetes', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes', 'Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'This proposal seeks to gather continuous blood glucose and physical activity data from individuals with and without diabetes.', 'detailedDescription': 'This proposal seeks to gather continuous blood glucose and physical activity data from individuals with and without diabetes who are physically active and exercising for health benefits. The investigators hypothesize that insulin requirements will be inversely related to intensity of activity and an algorithm will be able to detect physical activity and automatically adjust insulin doses. Once such an algorithm has been determined for an individual, it can be applied to future similar situations, but ideally the algorithm will be dynamically refined based on closed-loop feedback information.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'individuals without diabetes and those with type 1 and type 2 diabetes', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion criteria for subjects with diabetes\n* Type 1 diabetes or insulin requiring type 2 diabetes for at least 1 year\n* Use insulin to control diabetes\n* Physically active (regularly work out, swim, run, walk, bike, etc.)\n* Free of major micro- and macrovascular complications of diabetes\n* 18-75 years of age\n* A1C \\< 9.0% Inclusion criteria for subjects without diabetes\n* No evidence of diabetes and physically active\n\nExclusion Criteria:\n\n* unwilling to perform repeated glucose checks or take insulin as instructed\n* abnormal thyroid function, kidney function, liver function\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT02190669', 'briefTitle': 'Exercise and Diabetes - an Observational Study of Exercise and Blood Glucose Control', 'organization': {'class': 'OTHER', 'fullName': 'Sansum Diabetes Research Institute'}, 'officialTitle': 'Exercise and Diabetes - an Observational Study of Exercise and Blood Glucose Control', 'orgStudyIdInfo': {'id': '08-67'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'exercise in individuals without diabetes', 'description': 'exercise in individuals without diabetes', 'interventionNames': ['Other: exercise']}, {'label': 'exercise in type 1 diabetes', 'description': 'exercise in type 1 diabetes', 'interventionNames': ['Other: exercise']}, {'label': 'exercise in type 2 diabetes', 'description': 'exercise in type 2 diabetes', 'interventionNames': ['Other: exercise']}], 'interventions': [{'name': 'exercise', 'type': 'OTHER', 'description': 'Sprinting, walking on a treadmill, and stationary bicycle riding', 'armGroupLabels': ['exercise in individuals without diabetes', 'exercise in type 1 diabetes', 'exercise in type 2 diabetes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93105', 'city': 'Santa Barbara', 'state': 'California', 'country': 'United States', 'facility': 'Sansum Diabetes Research Institute', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}], 'overallOfficials': [{'name': 'Kristin Castorino, D.O.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sansum Diabetes Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sansum Diabetes Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}