Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT03534193
Status:
TERMINATED
Last Update Posted:
2025-12-17
First Post:
2018-05-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effectiveness of Using Educational Modules Via Bedside Tablet in Newly Diagnosed Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'steven.ghanny@hmhn.org', 'phone': '5519965329', 'title': 'Steven Ghanny, MD', 'organization': 'Hackensack Meridian Health'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The team experienced difficulties in collecting the number of blood sugar checks from the patients who did not report it for either group.'}}, 'adverseEventsModule': {'timeFrame': 'Up until study completion (3 months +/- 20 days)', 'eventGroups': [{'id': 'EG000', 'title': 'Standard Diabetes Education', 'description': 'Participants randomized to Group 1 will receive Standard Diabetic Education with Registered Nurse and Molly Center Diabetes Care Guide (paper-based)\n\nMolly Center Diabetes Care Guide (Paper-based): Diabetes education with Registered Nurse in addition to Paper based education modules', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Diabetes Education and Tablet', 'description': 'Participants randomized to Group 2 will receive Molly Center Standard Diabetes Education plus access to Tablet based interactive diabetes education modules\n\nMolly Center Diabetes Care Guide (Paper-based): Diabetes education with Registered Nurse in addition to Paper based education modules\n\nTablet based interactive diabetes education modules: Molly Center Standard Diabetes Education plus access to interactive diabetes education modules through bedside tablet.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Effectiveness of Tablet Education in Newly Diagnosed Type 1 Diabetes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Diabetes Education', 'description': 'Participants randomized to Group 1 will receive Standard Diabetic Education with Registered Nurse and Molly Center Diabetes Care Guide (paper-based)\n\nMolly Center Diabetes Care Guide (Paper-based): Diabetes education with Registered Nurse in addition to Paper based education modules'}, {'id': 'OG001', 'title': 'Standard Diabetes Education and Tablet', 'description': 'Participants randomized to Group 2 will receive Molly Center Standard Diabetes Education plus access to Tablet based interactive diabetes education modules\n\nMolly Center Diabetes Care Guide (Paper-based): Diabetes education with Registered Nurse in addition to Paper based education modules\n\nTablet based interactive diabetes education modules: Molly Center Standard Diabetes Education plus access to interactive diabetes education modules through bedside tablet.'}], 'classes': [{'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000', 'lowerLimit': '70', 'upperLimit': '90'}, {'value': '86', 'groupId': 'OG001', 'lowerLimit': '70', 'upperLimit': '90'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Test will be completed on day 3 (+/- 2 days)', 'description': 'Effectiveness of tablet education modules as measured by a diabetic knowledge post-test questionnaire.\n\nTotal score ranges from 0-100%, with a higher percentage on the scale indicating a better outcome/knowledge.', 'unitOfMeasure': 'percentage of questions answered correct', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'post-education test score (percentile of questions answered correctly)'}, {'type': 'SECONDARY', 'title': 'Improved Subject Compliance With Glucose Monitoring A1 Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Diabetes Education', 'description': 'Participants randomized to Group 1 will receive Standard Diabetic Education with Registered Nurse and Molly Center Diabetes Care Guide (paper-based)\n\nMolly Center Diabetes Care Guide (Paper-based): Diabetes education with Registered Nurse in addition to Paper based education modules'}, {'id': 'OG001', 'title': 'Standard Diabetes Education and Tablet', 'description': 'Participants randomized to Group 2 will receive Molly Center Standard Diabetes Education plus access to Tablet based interactive diabetes education modules\n\nMolly Center Diabetes Care Guide (Paper-based): Diabetes education with Registered Nurse in addition to Paper based education modules\n\nTablet based interactive diabetes education modules: Molly Center Standard Diabetes Education plus access to interactive diabetes education modules through bedside tablet.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '7.1', 'upperLimit': '14'}, {'value': '8.06', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '10.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessements will occur at 3 months', 'description': 'Subjects randomized to tablet education modules will demonstrate improved compliance with glucose monitoring as measured by Lower Hemoglobin A1C at initial follow up visit', 'unitOfMeasure': 'percentage change in HbA1C', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'lower HbA1C comparing to baseline'}, {'type': 'SECONDARY', 'title': 'Improved Subject Compliance With Glucose Monitoring - Hypoglycemic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Diabetes Education', 'description': 'Participants randomized to Group 1 will receive Standard Diabetic Education with Registered Nurse and Molly Center Diabetes Care Guide (paper-based)\n\nMolly Center Diabetes Care Guide (Paper-based): Diabetes education with Registered Nurse in addition to Paper based education modules'}, {'id': 'OG001', 'title': 'Standard Diabetes Education and Tablet', 'description': 'Participants randomized to Group 2 will receive Molly Center Standard Diabetes Education plus access to Tablet based interactive diabetes education modules\n\nMolly Center Diabetes Care Guide (Paper-based): Diabetes education with Registered Nurse in addition to Paper based education modules\n\nTablet based interactive diabetes education modules: Molly Center Standard Diabetes Education plus access to interactive diabetes education modules through bedside tablet.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '15'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessements will occur at 3 months', 'description': 'Subjects randomized to tablet education modules will demonstrate improved compliance with glucose monitoring as measured by lower number of hypoglycemic episodes before initial follow up visit', 'unitOfMeasure': 'number of Hypoglycemic Episodes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'number of Hypoglycemic Episodes'}, {'type': 'SECONDARY', 'title': 'Improved Subject Compliance With Glucose Monitoring - Compliance With Daily Blood Glucose Monitoring', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Diabetes Education', 'description': 'Participants randomized to Group 1 will receive Standard Diabetic Education with Registered Nurse and Molly Center Diabetes Care Guide (paper-based)\n\nMolly Center Diabetes Care Guide (Paper-based): Diabetes education with Registered Nurse in addition to Paper based education modules'}, {'id': 'OG001', 'title': 'Standard Diabetes Education and Tablet', 'description': 'Participants randomized to Group 2 will receive Molly Center Standard Diabetes Education plus access to Tablet based interactive diabetes education modules\n\nMolly Center Diabetes Care Guide (Paper-based): Diabetes education with Registered Nurse in addition to Paper based education modules\n\nTablet based interactive diabetes education modules: Molly Center Standard Diabetes Education plus access to interactive diabetes education modules through bedside tablet.'}], 'timeFrame': 'Assessements will occur at 3 months', 'description': 'Subjects randomized to tablet education modules will demonstrate improved compliance with glucose monitoring as measured by compliance with daily blood glucose monitoring at initial follow up visit', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of times blood sugar was checked. Data was not collected as patients did not report it for either group.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Diabetes Education', 'description': 'Participants randomized to Group 1 will receive Standard Diabetic Education with Registered Nurse and Molly Center Diabetes Care Guide (paper-based)\n\nMolly Center Diabetes Care Guide (Paper-based): Diabetes education with Registered Nurse in addition to Paper based education modules'}, {'id': 'FG001', 'title': 'Standard Diabetes Education and Tablet', 'description': 'Participants randomized to Group 2 will receive Molly Center Standard Diabetes Education plus access to Tablet based interactive diabetes education modules\n\nMolly Center Diabetes Care Guide (Paper-based): Diabetes education with Registered Nurse in addition to Paper based education modules\n\nTablet based interactive diabetes education modules: Molly Center Standard Diabetes Education plus access to interactive diabetes education modules through bedside tablet.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Diabetes Education', 'description': 'Participants randomized to Group 1 will receive Standard Diabetic Education with Registered Nurse and Molly Center Diabetes Care Guide (paper-based)\n\nMolly Center Diabetes Care Guide (Paper-based): Diabetes education with Registered Nurse in addition to Paper based education modules'}, {'id': 'BG001', 'title': 'Standard Diabetes Education and Tablet', 'description': 'Participants randomized to Group 2 will receive Molly Center Standard Diabetes Education plus access to Tablet based interactive diabetes education modules\n\nMolly Center Diabetes Care Guide (Paper-based): Diabetes education with Registered Nurse in addition to Paper based education modules\n\nTablet based interactive diabetes education modules: Molly Center Standard Diabetes Education plus access to interactive diabetes education modules through bedside tablet.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '9.78', 'groupId': 'BG000', 'lowerLimit': '3', 'upperLimit': '17'}, {'value': '8.85', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '17'}, {'value': '9.31', 'groupId': 'BG002', 'lowerLimit': '2', 'upperLimit': '17'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2017-03-31', 'size': 263921, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-05-30T14:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized to one of 2 arms:\n\nGroup 1 - standard Diabetic education-consisting of one on one education with a Registered Nurse in addition to the Molly Center Diabetes Care Guide (paper based) Group 2 - standard Diabetic education plus Bedside tablet with interactive Diabetic modules'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'whyStopped': 'Site resources', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2018-05-09', 'resultsFirstSubmitDate': '2025-05-08', 'studyFirstSubmitQcDate': '2018-05-21', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-12-01', 'studyFirstPostDateStruct': {'date': '2018-05-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness of Tablet Education in Newly Diagnosed Type 1 Diabetes', 'timeFrame': 'Test will be completed on day 3 (+/- 2 days)', 'description': 'Effectiveness of tablet education modules as measured by a diabetic knowledge post-test questionnaire.\n\nTotal score ranges from 0-100%, with a higher percentage on the scale indicating a better outcome/knowledge.'}], 'secondaryOutcomes': [{'measure': 'Improved Subject Compliance With Glucose Monitoring A1 Levels', 'timeFrame': 'Assessements will occur at 3 months', 'description': 'Subjects randomized to tablet education modules will demonstrate improved compliance with glucose monitoring as measured by Lower Hemoglobin A1C at initial follow up visit'}, {'measure': 'Improved Subject Compliance With Glucose Monitoring - Hypoglycemic Episodes', 'timeFrame': 'Assessements will occur at 3 months', 'description': 'Subjects randomized to tablet education modules will demonstrate improved compliance with glucose monitoring as measured by lower number of hypoglycemic episodes before initial follow up visit'}, {'measure': 'Improved Subject Compliance With Glucose Monitoring - Compliance With Daily Blood Glucose Monitoring', 'timeFrame': 'Assessements will occur at 3 months', 'description': 'Subjects randomized to tablet education modules will demonstrate improved compliance with glucose monitoring as measured by compliance with daily blood glucose monitoring at initial follow up visit'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': "This is a prospective, randomized trial to evaluate the effectiveness of using educational modules accessed through a bedside tablet in patients newly diagnosed with Type 1 Diabetes as an adjunct to \\*standard Children's Hospital- Molly Center diabetes education in comparison to \\*standard Children's Hospital- Molly Center diabetes education. (standard diabetes education consists of paper based reading material and nursing education).", 'detailedDescription': "Type I diabetes is one of the most common diseases of childhood and its incidence has been increasing worldwide. By age 18, 1 in 300 children will be affected by Type 1 Diabetes1. Not only are children diagnosed with diabetes met with significant morbidity due to their disease, but they are also expected to be active participants in daily often complicated treatment regimens. As children with Type 1 diabetes grow older and eventually spend time away from their parents or caregivers, they are forced to manage their own care. Over the last several years, health systems in the United States have become more patient-centered and have focused on autonomy and patient preference. With the advent of technology that makes self-directed education possible, this patient-centered approach needs to be applied to children diagnosed with Type I diabetes.\n\nWhen clinicians are at the center of educating patients with diabetes, they often communicate more directly with parents, who then use the information they receive to manage their child's care. This model, however, does not account for the fact that children with diabetes will one day need to manage their own care and that patients who are active participants and who understand their disease process will be more likely to cooperate with treatment regimens and lifestyle interventions. It is often difficult for any patient, child or adult, to process educational information provided verbally in a physician's office, especially immediately after they have been diagnosed with a life-long disease. Educational tools therefore need to focus on incorporating methods that best serve the patients being educated.\n\nSince individuals learn in different ways and at different paces, interactive educational tools can help patients and their families learn in a way that can be individualized and private and can also be fun and creative. As our patients are growing up surrounded by technology, the use of this technology for education might provide a sense of normalcy to children and teenagers already overwhelmed by processes that are often difficult for them to identify with or understand. We hope that patients and families who are given the opportunity to learn independently will become better equipped to manage self-care and will develop a sense of involvement in their treatment. Interactive tools will also help patients and families become more actively engaged in understanding their disease process and can help them to become more active participants in their care."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* New diagnosed Type 1 Diabetes admitted to the Joseph M. Sanzari Children's Hospital\n* Patient/Caretaker/Family willing to complete questionnaires\n\nExclusion Criteria:\n\n* Patients with previous history of Diabetes\n* Patients with no plans to follow up at The Joseph M. Sanzari Children's Hospital - Molly's Center for Children with Diabetes and Endocrine Disorders after hospital discharge\n* Non English speaking patients/family/caretaker"}, 'identificationModule': {'nctId': 'NCT03534193', 'briefTitle': 'Effectiveness of Using Educational Modules Via Bedside Tablet in Newly Diagnosed Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Hackensack Meridian Health'}, 'officialTitle': 'Effectiveness of Using Educational Modules Via Bedside Tablet in Newly Diagnosed Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'PRO 2016-0713'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Standard Diabetic Education', 'description': 'Participants randomized to Group 1 will receive Standard Diabetic Education with Registered Nurse and Molly Center Diabetes Care Guide (paper-based)', 'interventionNames': ['Other: Molly Center Diabetes Care Guide (Paper-based)']}, {'type': 'EXPERIMENTAL', 'label': 'Standard Diabetes Education and Tablet', 'description': 'Participants randomized to Group 2 will receive Molly Center Standard Diabetes Education plus access to Tablet based interactive diabetes education modules', 'interventionNames': ['Other: Molly Center Diabetes Care Guide (Paper-based)', 'Other: Tablet based interactive diabetes education modules']}], 'interventions': [{'name': 'Molly Center Diabetes Care Guide (Paper-based)', 'type': 'OTHER', 'description': 'Diabetes education with Registered Nurse in addition to Paper based education modules', 'armGroupLabels': ['Standard Diabetes Education and Tablet', 'Standard Diabetic Education']}, {'name': 'Tablet based interactive diabetes education modules', 'type': 'OTHER', 'description': 'Molly Center Standard Diabetes Education plus access to interactive diabetes education modules through bedside tablet.', 'armGroupLabels': ['Standard Diabetes Education and Tablet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': "Joseph M. Sanzari Children's Hospital", 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}], 'overallOfficials': [{'name': 'Steven Ghanny, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Joseph M.Sanzari Children's Hospital at Hackensack University Medical Center"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hackensack Meridian Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Verizon Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}