Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-01-04 @ 7:58 PM
Study NCT ID:
NCT02682056
Status:
COMPLETED
Last Update Posted:
2020-01-03
First Post:
2016-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Glucose Measurement Using Microneedle Patches
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057785', 'term': 'Catheters'}], 'ancestors': [{'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'efelner@emory.edu', 'phone': '404-727-7651', 'title': 'Eric Felner MD', 'organization': 'Emory University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Information about adverse events were collected from the time the study assessments began (Hour 1 on study Day 1) through the end of study procedures on study Day 1.', 'eventGroups': [{'id': 'EG000', 'title': 'Microneedle', 'description': 'Microneedle patches were used to collect interstitial fluid for glucose testing. Participants had fasting glucose levels measured four time, on an hourly basis, during the study visit.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Lancet', 'description': 'Lancets were used to collect capillary blood for glucose testing. Participants had fasting glucose levels measured four time, on an hourly basis, during the study visit.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Intravenous Catheter', 'description': 'Intravenous catheters were used to collect venous blood for glucose testing. Participants had fasting glucose levels measured four time, on an hourly basis, during the study visit.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Glucose Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Microneedle', 'description': 'Microneedle patches were used to collect interstitial fluid for glucose testing. Participants had fasting glucose levels measured four time, on an hourly basis, during the study visit.'}, {'id': 'OG001', 'title': 'Lancet', 'description': 'Lancets were used to collect capillary blood for glucose testing. Participants had fasting glucose levels measured four time, on an hourly basis, during the study visit.'}, {'id': 'OG002', 'title': 'Intravenous Catheter', 'description': 'Intravenous catheters were used to collect venous blood for glucose testing. Participants had fasting glucose levels measured four time, on an hourly basis, during the study visit.'}], 'classes': [{'title': 'Baseline/Hour 1', 'categories': [{'measurements': [{'value': '137', 'spread': '119', 'groupId': 'OG000'}, {'value': '174.5', 'spread': '58', 'groupId': 'OG001'}, {'value': '160.9', 'spread': '58', 'groupId': 'OG002'}]}]}, {'title': 'Hour 2', 'categories': [{'measurements': [{'value': '155', 'spread': '78', 'groupId': 'OG000'}, {'value': '271.4', 'spread': '91', 'groupId': 'OG001'}, {'value': '227.3', 'spread': '65', 'groupId': 'OG002'}]}]}, {'title': 'Hour 3', 'categories': [{'measurements': [{'value': '256', 'spread': '224', 'groupId': 'OG000'}, {'value': '270.4', 'spread': '82', 'groupId': 'OG001'}, {'value': '270.4', 'spread': '82', 'groupId': 'OG002'}]}]}, {'title': 'Hour 4', 'categories': [{'measurements': [{'value': '285', 'spread': '126', 'groupId': 'OG000'}, {'value': '276.4', 'spread': '122.9', 'groupId': 'OG001'}, {'value': '251.5', 'spread': '122.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Hour 1), Hour 2, Hour 3, Hour 4', 'description': 'Participants had their glucose levels tested through three different methods. Interstitial glucose levels was assessed using a microneedles patch. Blood glucose levels were collected via the lancet and intravenous (IV) collection methods.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Apprehension Level Assessed by Apprehension Visual Analog Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Microneedle', 'description': 'Microneedle patches were used to collect interstitial fluid for glucose testing. Participants had fasting glucose levels measured four time, on an hourly basis, during the study visit.'}, {'id': 'OG001', 'title': 'Lancet', 'description': 'Lancets were used to collect capillary blood for glucose testing. Participants had fasting glucose levels measured four time, on an hourly basis, during the study visit.'}, {'id': 'OG002', 'title': 'Intravenous Catheter', 'description': 'Intravenous catheters were used to collect venous blood for glucose testing. Participants had fasting glucose levels measured four time, on an hourly basis, during the study visit.'}], 'classes': [{'title': 'Baseline/Hour 1', 'categories': [{'measurements': [{'value': '24.1', 'spread': '23.0', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '16.9', 'groupId': 'OG001'}, {'value': '30.8', 'spread': '24.7', 'groupId': 'OG002'}]}]}, {'title': 'Hour 4', 'categories': [{'measurements': [{'value': '12.2', 'spread': '14.1', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '15.3', 'groupId': 'OG001'}, {'value': '24.4', 'spread': '20.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline ( Hour 1), Hour 4', 'description': 'Participants completed a Visual Analog Scale (VAS) to report the level of apprehension they felt regarding each method of sample collection. Participants will mark on a line scale (between not afraid and very afraid) to indicate fear level when a sample is collected. The range is from 0-100 mm with 0 mm indicating no apprehension and 100 mm indicating the most apprehension.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Level Assessed by Pain Visual Analog Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Microneedle', 'description': 'Microneedle patches were used to collect interstitial fluid for glucose testing. Participants had fasting glucose levels measured four time, on an hourly basis, during the study visit.'}, {'id': 'OG001', 'title': 'Lancet', 'description': 'Lancets were used to collect capillary blood for glucose testing. Participants had fasting glucose levels measured four time, on an hourly basis, during the study visit.'}, {'id': 'OG002', 'title': 'Intravenous Catheter', 'description': 'Intravenous catheters were used to collect venous blood for glucose testing. Participants had fasting glucose levels measured four time, on an hourly basis, during the study visit.'}], 'classes': [{'title': 'Baseline/Hour 1', 'categories': [{'measurements': [{'value': '22.5', 'spread': '22.0', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '16.9', 'groupId': 'OG001'}, {'value': '33.4', 'spread': '24.3', 'groupId': 'OG002'}]}]}, {'title': 'Hour 4', 'categories': [{'measurements': [{'value': '11.2', 'spread': '13.5', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '14.4', 'groupId': 'OG001'}, {'value': '26.8', 'spread': '21.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline ( Hour 1), Hour 4', 'description': 'Participants completed a Visual Analog Scale (VAS) to report the level of pain they felt regarding each method of sample collection. Participants marked on a line scale (between no pain and worst pain ever) to indicate pain level when a sample is collected. The range is from 0-100 mm with 0 mm indicating no pain and 100 mm indicating the most extreme pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Children Having Glucose Levels Tested Through Three Methods', 'description': 'Children and adolescents with diabetes having blood glucose levels tested using microneedle patches, intravenous (IV) catheter draw, and lancet. Sample collection with the different methods will occur simultaneously four times, on an hourly basis, during a single study visit.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Participants were enrolled between December 2017 and January 2018 from the Emory Children's Center and Children's Healthcare of Atlanta, in Atlanta, Georgia."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Children Having Glucose Levels Tested Through Three Methods', 'description': 'Children and adolescents with diabetes having blood glucose levels tested using microneedle patches, intravenous (IV) catheter draw, and lancet.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '16.8', 'spread': '3.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-12-06', 'size': 212100, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-12-03T11:42', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'dispFirstSubmitDate': '2019-01-14', 'completionDateStruct': {'date': '2018-01-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-16', 'studyFirstSubmitDate': '2016-02-10', 'dispFirstSubmitQcDate': '2019-01-14', 'resultsFirstSubmitDate': '2019-12-16', 'studyFirstSubmitQcDate': '2016-02-10', 'dispFirstPostDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-01-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-16', 'studyFirstPostDateStruct': {'date': '2016-02-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glucose Level', 'timeFrame': 'Baseline (Hour 1), Hour 2, Hour 3, Hour 4', 'description': 'Participants had their glucose levels tested through three different methods. Interstitial glucose levels was assessed using a microneedles patch. Blood glucose levels were collected via the lancet and intravenous (IV) collection methods.'}], 'secondaryOutcomes': [{'measure': 'Apprehension Level Assessed by Apprehension Visual Analog Scale (VAS)', 'timeFrame': 'Baseline ( Hour 1), Hour 4', 'description': 'Participants completed a Visual Analog Scale (VAS) to report the level of apprehension they felt regarding each method of sample collection. Participants will mark on a line scale (between not afraid and very afraid) to indicate fear level when a sample is collected. The range is from 0-100 mm with 0 mm indicating no apprehension and 100 mm indicating the most apprehension.'}, {'measure': 'Pain Level Assessed by Pain Visual Analog Scale (VAS)', 'timeFrame': 'Baseline ( Hour 1), Hour 4', 'description': 'Participants completed a Visual Analog Scale (VAS) to report the level of pain they felt regarding each method of sample collection. Participants marked on a line scale (between no pain and worst pain ever) to indicate pain level when a sample is collected. The range is from 0-100 mm with 0 mm indicating no pain and 100 mm indicating the most extreme pain.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Pediatrics', 'Endocrinology', 'Adolescent', 'Microneedle'], 'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'This study will compare three glucose measurement techniques among diabetic children and adolescents. The study seeks to determine if a microneedle patch (made from biocompatible polymers or metal), versus a lancet or intravenous catheter, would be a preferable option for monitoring glucose levels among the diabetic pediatric population.', 'detailedDescription': 'Fifteen children and adolescents with diabetes will be tested for their glucose measurements comparing interstitial fluid collected via a microneedle patch (made from biocompatible polymers or metal), versus the standard of care blood sample (lancet), and lab grade blood draw (intravenous catheter). Samples will be taken hourly from all three devices for four hours. All four measurements will be compared against each other to see how close they are with measuring the glucose values. Each participant will be asked to rate their apprehension prior to receiving each method for blood or interstitial fluid collection as well as the pain associated with each method immediately after collection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diabetes diagnosis\n\nExclusion Criteria:\n\n* no exclusion criteria are specified'}, 'identificationModule': {'nctId': 'NCT02682056', 'acronym': 'GUMP', 'briefTitle': 'Glucose Measurement Using Microneedle Patches', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Glucose Measurement Using Microneedle Patches', 'orgStudyIdInfo': {'id': 'IRB00075816'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Single Study Arm', 'description': 'Children and adolescents with diabetes will have blood glucose levels tested using microneedle patches, intravenous (IV) catheter draw, and lancet.', 'interventionNames': ['Device: Microneedle patch', 'Device: Intravenous (IV) catheter', 'Device: Lancet']}], 'interventions': [{'name': 'Microneedle patch', 'type': 'DEVICE', 'description': 'The microneedle patch will collect interstitial fluid to be tested for glucose level. The microneedles are made from biocompatible polymers or metal. Participants will have fasting glucose levels measured four times, on an hourly basis, during the study visit.', 'armGroupLabels': ['Single Study Arm']}, {'name': 'Intravenous (IV) catheter', 'type': 'DEVICE', 'description': 'The intravenous (IV) catheter will collect venous blood to be tested for glucose level. Participants will have fasting glucose levels measured four times, on an hourly basis, during the study visit.', 'armGroupLabels': ['Single Study Arm']}, {'name': 'Lancet', 'type': 'DEVICE', 'description': 'The lancet will collect capillary blood to be tested for glucose level. Participants will have fasting glucose levels measured four times, on an hourly basis, during the study visit.', 'armGroupLabels': ['Single Study Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Healthcare of Atlanta", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Emory Children's Center", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Eric Felner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Eric Felner, MD, MSCR', 'investigatorAffiliation': 'Emory University'}}}}