Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT05131451
Status:
COMPLETED
Last Update Posted:
2023-11-02
First Post:
2021-11-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
ACCESS: AI for pediatriC diabetiC Eye examS Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003930', 'term': 'Diabetic Retinopathy'}], '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'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rwolf@jhu.edu', 'phone': '4109556463', 'title': 'Dr. Risa Wolf', 'organization': 'Johns Hopkins University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Autonomous AI is not FDA cleared for use in ages 21 and under. Some participants were familiar with autonomous AI diabetic eye exams from a prior study and may have been more accepting of participation in the current study.\n\nAlthough pharmacologic dilation is not necessary in the pediatric population to obtain sufficient fundus imaging, this may not be applicable to adults where real-world studies have demonstrated higher rates of insufficient images without pharmacologic dilation.'}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Usual Care With Educational Reinforcement', 'description': 'Standard of care referral to Eye Care Provider (ECP) for the diabetic eye exam with educational reinforcement', 'otherNumAtRisk': 83, 'deathsNumAtRisk': 83, 'otherNumAffected': 0, 'seriousNumAtRisk': 83, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Diabetic Retinopathy Exam', 'description': 'Point of care (POC) Diabetic Retinopathy Exam using Autonomous AI on non-mydriatic fundus camera\n\nPoint of Care Autonomous AI diabetic retinopathy exam: Participants will get a point of care diabetic retinopathy eye exam using autonomous AI. Those that test positive will be referred to Eye Care Provider for dilated eye exam.', 'otherNumAtRisk': 81, 'deathsNumAtRisk': 81, 'otherNumAffected': 0, 'seriousNumAtRisk': 81, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Get Screened With a Diabetic Eye Exam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care With Educational Reinforcement', 'description': 'Standard of care referral to Eye Care Provider (ECP) for the diabetic eye exam with educational reinforcement'}, {'id': 'OG001', 'title': 'Diabetic Retinopathy Exam', 'description': 'Point of care (POC) Diabetic Retinopathy Exam using Autonomous AI on non-mydriatic fundus camera\n\nPoint of Care Autonomous AI diabetic retinopathy exam: Participants will get a point of care diabetic retinopathy eye exam using autonomous AI. Those that test positive will be referred to Eye Care Provider for dilated eye exam.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'The number of participants who get screened with a diabetic eye exam will be assessed for the AI group and the standard of care group referral to an eye care provider (ECP).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Follow-up Rates With an Eye Care Provider', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care With Educational Reinforcement', 'description': 'Standard of care referral to Eye Care Provider (ECP) for the diabetic eye exam with educational reinforcement'}, {'id': 'OG001', 'title': 'Diabetic Retinopathy Exam', 'description': 'Point of care (POC) Diabetic Retinopathy Exam using Autonomous AI on non-mydriatic fundus camera\n\nPoint of Care Autonomous AI diabetic retinopathy exam: Participants will get a point of care diabetic retinopathy eye exam using autonomous AI. Those that test positive will be referred to Eye Care Provider for dilated eye exam.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'The number of patients that follow-up with an eye care provider (ECP), for participants in the standard of care group referred to ECP, and for participants in the AI group with an abnormal exam result that are then referred to the ECP for a dilated eye exam.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The diabetic retinopathy exam group only includes those that had an abnormal AI exam and were referred to an eye care provider for a dilated eye exam.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Usual Care With Educational Reinforcement', 'description': 'Standard of care referral to Eye Care Provider (ECP) for the diabetic eye exam with educational reinforcement'}, {'id': 'FG001', 'title': 'Diabetic Retinopathy Exam', 'description': 'Point of care (POC) Diabetic Retinopathy Exam using Autonomous AI (artificial intelligence) on non-mydriatic fundus camera\n\nPoint of Care Autonomous AI diabetic retinopathy exam: Participants will get a point of care diabetic retinopathy eye exam using autonomous AI. Those that test positive will be referred to Eye Care Provider for dilated eye exam.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '81'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'One patient in the usual care arm was inadvertently enrolled in another eye screening study.', 'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '81'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Usual Care With Educational Reinforcement', 'description': 'Standard of care referral to Eye Care Provider (ECP) for the diabetic eye exam with educational reinforcement'}, {'id': 'BG001', 'title': 'Diabetic Retinopathy Exam', 'description': 'Point of care (POC) Diabetic Retinopathy Exam using Autonomous AI on non-mydriatic fundus camera\n\nPoint of Care Autonomous AI diabetic retinopathy exam: Participants will get a point of care diabetic retinopathy eye exam using autonomous AI. Those that test positive will be referred to Eye Care Provider for dilated eye exam.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '15.1', 'spread': '2.8', 'groupId': 'BG000'}, {'value': '15.3', 'spread': '2.8', 'groupId': 'BG001'}, {'value': '15.2', 'spread': '2.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Non-Hispanic Black', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Non-Hispanic White', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-09-05', 'size': 334335, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-09-06T23:02', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Participants are masked to the study arms until after randomization'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1. Control Arm - Standard of care referral to an eye care provider + Educational Reinforcement\n2. Intervention Arm - Point of Care Diabetic Retinopathy screening using Autonomous artificial intelligence on a non-mydriatic fundus camera'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 164}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-09', 'studyFirstSubmitDate': '2021-11-11', 'resultsFirstSubmitDate': '2023-10-09', 'studyFirstSubmitQcDate': '2021-11-11', 'lastUpdatePostDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-10-09', 'studyFirstPostDateStruct': {'date': '2021-11-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Get Screened With a Diabetic Eye Exam', 'timeFrame': '6 months', 'description': 'The number of participants who get screened with a diabetic eye exam will be assessed for the AI group and the standard of care group referral to an eye care provider (ECP).'}], 'secondaryOutcomes': [{'measure': 'Follow-up Rates With an Eye Care Provider', 'timeFrame': '6 months', 'description': 'The number of patients that follow-up with an eye care provider (ECP), for participants in the standard of care group referred to ECP, and for participants in the AI group with an abnormal exam result that are then referred to the ECP for a dilated eye exam.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Diabetic Retinopathy'], 'conditions': ['Type 1 Diabetes', 'Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if providing in clinic point-of-care autonomous AI diabetic retinopathy exams improves screening rates compared to standard of care referral to an eye care provider, in a randomized control trial in a racially and ethnically diverse cohort of youth.', 'detailedDescription': 'This study will recruit 164 individuals ages 8-21 with type 1 and type 2 diabetes. Participants will be randomized to usual care (referral to an eye care provider for a dilated eye exam) or the intervention arm and undergo a point-of-care diabetic eye exam using autonomous AI software on a non-mydriatic fundus camera. Participants in the intervention group will receive the diabetic eye exam results immediately from the autonomous AI system, and if abnormal will be referred to an eye care provider for a dilated eye exam. Participants in the standard of care group will have 6 months to complete the diabetic eye exam.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMeets American Diabetes Association (ADA) criteria for diabetic retinopathy screening:\n\n* Diagnosis of Type 1 diabetes for ≥3 years, and age 11 or in puberty\n* Diagnosis of Type 2 diabetes\n\nExclusion Criteria:\n\n* Diabetic eye exam within the last 6 months\n* Known diabetic retinopathy'}, 'identificationModule': {'nctId': 'NCT05131451', 'acronym': 'ACCESS', 'briefTitle': 'ACCESS: AI for pediatriC diabetiC Eye examS Study', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Autonomous AI for Diabetic Retinopathy Screening in Youth (AI-DR): A Randomized Control Trial', 'orgStudyIdInfo': {'id': 'IRB00288043'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual care with educational reinforcement', 'description': 'Standard of care referral to Eye Care Provider (ECP) for the diabetic eye exam with educational reinforcement'}, {'type': 'EXPERIMENTAL', 'label': 'Diabetic Retinopathy Exam', 'description': 'Point of care (POC) Diabetic Retinopathy Exam using Autonomous AI on non-mydriatic fundus camera', 'interventionNames': ['Diagnostic Test: Point of Care Autonomous AI diabetic retinopathy exam']}], 'interventions': [{'name': 'Point of Care Autonomous AI diabetic retinopathy exam', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['IDx-DR'], 'description': 'Participants will get a point of care diabetic retinopathy eye exam using autonomous AI. Those that test positive will be referred to Eye Care Provider for dilated eye exam.', 'armGroupLabels': ['Diabetic Retinopathy Exam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Pediatric Diabetes Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Risa Wolf, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Eye Institute (NEI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}