Ignite Creation Date:
2025-12-25 @ 1:42 AM
Ignite Modification Date:
2026-03-04 @ 1:36 PM
Study NCT ID:
NCT02434094
Status:
COMPLETED
Last Update Posted:
2016-10-25
First Post:
2015-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of a Comprehensive AP Training Curriculum for Adults
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-24', 'studyFirstSubmitDate': '2015-04-29', 'studyFirstSubmitQcDate': '2015-04-29', 'lastUpdatePostDateStruct': {'date': '2016-10-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validated eDAPT training tool', 'timeFrame': '2 hours', 'description': 'Subjects learn how to properly operate \\& configure DiAs.'}, {'measure': 'Human factors feedback', 'timeFrame': '2 hours', 'description': 'Administration of knowledge tests and focus groups'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes Assistant (DiAs)', 'Continuous Glucose Monitor (CGM)', 'Insulin Pump', 'Human Factors', 'Focus Group', 'Artificial Pancreas (AP)', 'eDAPT (electronic Diabetes Artificial Pancreas Training)'], 'conditions': ['Diabetes Mellitus, Type 1']}, 'descriptionModule': {'briefSummary': "An e-learning training program is to prepare people with diabetes and their physicians on the use of UVA's Artificial Pancreas prototype -- Diabetes Assistant (DiAs).", 'detailedDescription': "This project will develop and test a comprehensive, web based training system for the artificial pancreas (AP) prototype identified as eDAPT (electronic Diabetes Artificial Pancreas Training). This e-learning training program is to prepare people with diabetes and their physicians on the use of UVA's Artificial Pancreas prototype -- Diabetes Assistant (DiAs), a software platform for the development and outpatient testing of smart phone based systems for Closed Loop Control of diabetes. The e-learning training program will be used in adjunct to in-person training with study staff at the onset of a clinical trial. It will be especially important as the number of clinical sites that use DiAs continue to grow both in the United States and internationally. It is also a critical step in moving the DiAs closer to a commercial product. A validated training program is required to proceed with the Food and Drug Administration (FDA) for both pivotal clinical trials and commercial approval of the AP."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* clinicians who manage patients on insulin pumps and continuous glucose monitors\n* participants former study participants who have experience operating DiAs.\n* participants who wear an insulin pump and continuous glucose monitor but have no experience DiAs.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Diabetes Clinicians Inclusion Criteria:\n\n* Endocrinologist, Certified Diabetes Educator, Nurse Practitioner actively managing patients with type 1 diabetes on insulin pumps and continuous glucose monitoring therapy\n* Actively managing patients using insulin pumps for at least one year\n\nFormer \\& Novice Study Subjects Inclusion Criteria:\n\n* Have Type 1 Diabetes Mellitus as defined by American Diabetes Association criteria or judgment of physician for at least 1 year\n* No previous experience with the artificial pancreas system in a clinical trial\n* Currently using insulin pump to manage their type 1 diabetes for at least one year\n* Actively using an insulin pump with bolus calculator feature including predefined parameters for carbohydrate ratio, insulin sensitivity factor, target BG and active insulin\n* Knowledge of continuous glucose monitors\n\nFormer Study Subjects Inclusion Criteria:\n\n• Previous experience with the artificial pancreas system in a clinical trial'}, 'identificationModule': {'nctId': 'NCT02434094', 'briefTitle': 'Development of a Comprehensive AP Training Curriculum for Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Development of a Comprehensive AP Training Curriculum for Adults', 'orgStudyIdInfo': {'id': '18032'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'T1DM Clinicians', 'description': 'Clinicals currently teaching T1DM patients how to use insulin pumps and continuous glucose monitors will be asked to complete the eDAPT on-line training program.', 'interventionNames': ['Behavioral: eDAPT on-line training program']}, {'label': 'T1DM Subjects with DiAs experience', 'description': 'T1DM subjects will prior DiAs experience will be asked to complete the eDAPT on-line training program.', 'interventionNames': ['Behavioral: eDAPT on-line training program']}, {'label': 'T1DM Subjects with no prior DiAs experience', 'description': 'T1DM subjects will no prior DiAs experience will be asked to complete the eDAPT on-line training program.', 'interventionNames': ['Behavioral: eDAPT on-line training program']}], 'interventions': [{'name': 'eDAPT on-line training program', 'type': 'BEHAVIORAL', 'description': 'A series of modules used to train on the web based training system for the artificial pancreas (AP) prototype, DiAs.', 'armGroupLabels': ['T1DM Clinicians', 'T1DM Subjects with DiAs experience', 'T1DM Subjects with no prior DiAs experience']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia Center for Diabetes Technology', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'Sue Brown, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UVA Center for Diabetes Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sue Brown', 'investigatorAffiliation': 'University of Virginia'}}}}