Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-01-25 @ 8:29 AM
Study NCT ID:
NCT03020069
Status:
COMPLETED
Last Update Posted:
2020-03-16
First Post:
2017-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Use of Continuous Glucose Monitoring System With Intensive Feedback in Adolescents With Poorly Controlled Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
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Item scaling is a 5-point scale from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. The total score is calculated as the sum of all items over the number of items answered on all the scales (total score ranges from 0-3300). Higher scores indicate lower problems. The change in total score is calculated by subtracting the total score at baseline from the total score at 3 months.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Glycated Hemoglobin (HbA1c) Levels From Baseline to 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glucose Meter', 'description': 'Continuing Glucose Monitoring Device\n\nCGMS Device'}, {'id': 'OG001', 'title': 'No Glucose Meter', 'description': 'Average Blood glucose measure\n\nNo Device'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.4', 'groupId': 'OG000', 'lowerLimit': '-132', 'upperLimit': '67'}, {'value': '-36', 'groupId': 'OG001', 'lowerLimit': '-194', 'upperLimit': '24'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 Months', 'description': "HbA1c measurements will be measured in the lab at the location of the patient's visit at baseline and 3 months. The measured HbA1c level at 3 months will be subtracted from the measured level at baseline to calculate the change.", 'unitOfMeasure': 'mmol/mol', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Level of Blood Sugar (Glucose) From Baseline to 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glucose Meter', 'description': 'Continuing Glucose Monitoring Device\n\nCGMS Device'}, {'id': 'OG001', 'title': 'No Glucose Meter', 'description': 'Average Blood glucose measure\n\nNo Device'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-18.3', 'upperLimit': '0.7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '0.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 Months', 'description': 'Blood sugar (glucose) will be measured via glucose monitors. The change in level of blood sugar will be calculated by subtracting the blood glucose level at 3 months from the blood glucose level at baseline.', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Score of Diabetes Empowerment Scale Short Form (DES-SF) From Baseline to 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glucose Meter', 'description': 'Continuing Glucose Monitoring Device\n\nCGMS Device'}, {'id': 'OG001', 'title': 'No Glucose Meter', 'description': 'Average Blood glucose measure\n\nNo Device'}], 'classes': [{'categories': [{'measurements': [{'value': '0.375', 'groupId': 'OG000', 'lowerLimit': '-.375', 'upperLimit': '0.875'}, {'value': '-0.25', 'groupId': 'OG001', 'lowerLimit': '-0.625', 'upperLimit': '0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months', 'description': 'There are 8 items that constitute the DES-SF. The scale is scored by averaging the scores of all completed items. 1 = strongly disagree and 5 = strongly agree. The change in score between baseline and 3 months will be calculated by subtracting the average score from 3 months from the baseline score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Glucose Meter', 'description': 'Continuing Glucose Monitoring Device\n\nCGMS Device'}, {'id': 'FG001', 'title': 'No Glucose Meter', 'description': 'Average Blood glucose measure\n\nNo Device'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Glucose Meter', 'description': 'Continuing Glucose Monitoring Device\n\nCGMS Device'}, {'id': 'BG001', 'title': 'No Glucose Meter', 'description': 'Average Blood glucose measure\n\nNo Device'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000', 'lowerLimit': '14', 'upperLimit': '18'}, {'value': '17', 'groupId': 'BG001', 'lowerLimit': '16', 'upperLimit': '18'}, {'value': '16', 'groupId': 'BG002', 'lowerLimit': '14', 'upperLimit': '18'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-04-26', 'size': 858939, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-02-06T12:23', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2018-07-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-12', 'studyFirstSubmitDate': '2017-01-11', 'resultsFirstSubmitDate': '2020-02-06', 'studyFirstSubmitQcDate': '2017-01-11', 'lastUpdatePostDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-12', 'studyFirstPostDateStruct': {'date': '2017-01-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Score of Pediatric Quality of Life Inventory 3.2 Diabetes Module (Peds QL 3.2) From Baseline to 3 Months', 'timeFrame': 'Baseline, 3 Months', 'description': 'The PedsQL 3.2 Diabetes Module is composed of 33 items. Item scaling is a 5-point scale from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. The total score is calculated as the sum of all items over the number of items answered on all the scales (total score ranges from 0-3300). Higher scores indicate lower problems. The change in total score is calculated by subtracting the total score at baseline from the total score at 3 months.'}, {'measure': 'Change in Glycated Hemoglobin (HbA1c) Levels From Baseline to 3 Months', 'timeFrame': 'Baseline, 3 Months', 'description': "HbA1c measurements will be measured in the lab at the location of the patient's visit at baseline and 3 months. The measured HbA1c level at 3 months will be subtracted from the measured level at baseline to calculate the change."}, {'measure': 'Change in Level of Blood Sugar (Glucose) From Baseline to 3 Months', 'timeFrame': 'Baseline, 3 Months', 'description': 'Blood sugar (glucose) will be measured via glucose monitors. The change in level of blood sugar will be calculated by subtracting the blood glucose level at 3 months from the blood glucose level at baseline.'}, {'measure': 'Change in Score of Diabetes Empowerment Scale Short Form (DES-SF) From Baseline to 3 Months', 'timeFrame': 'Baseline, 3 months', 'description': 'There are 8 items that constitute the DES-SF. The scale is scored by averaging the scores of all completed items. 1 = strongly disagree and 5 = strongly agree. The change in score between baseline and 3 months will be calculated by subtracting the average score from 3 months from the baseline score.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Type 1 Diabetes', 'Adolescents', 'Glucose Monitoring'], 'conditions': ['Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine that continuous glucose monitoring systems (CGMS) with intensive real time feedback about diabetes management from medical staff to the patient will affect motivation and/or behavior, in adolescents with poorly controlled type 1 diabetes. The investigators hypothesize that short-term CGMS use with feedback (and/or lack thereof) and patients' sense of self-efficacy will influence their stage of change and potentially glucose levels.", 'detailedDescription': 'Sixty adolescents, ages 13-19 years, with type 1 diabetes and an HbA1c \\> = 8 % who are also naive to CGMS use will be recruited from the diabetes outpatient population followed at Bellevue Hospital, Lutheran Hospital, Woodhull Hospital, and the NYU Fink Pediatric Ambulatory Care Center. Forty subjects will be randomly assigned to the CGMS group and 20 subjects will be assigned to the control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* type 1 diabetes\n* HbA1c \\> = 8 %\n* naive to CGMS use\n\nExclusion Criteria:\n\n* Patients with developmental delay\n* Patients who do not use a glucose meter to test capillary blood glucose level\n* Patients without access to a telephone will be excluded.'}, 'identificationModule': {'nctId': 'NCT03020069', 'briefTitle': 'Use of Continuous Glucose Monitoring System With Intensive Feedback in Adolescents With Poorly Controlled Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Use of Continuous Glucose Monitoring System With Intensive Feedback in Adolescents With Poorly Controlled Type 1 Diabetes', 'orgStudyIdInfo': {'id': '16-01011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glucose Meter', 'description': 'Continuing Glucose Monitoring Device', 'interventionNames': ['Device: CGMS Device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No Glucose Meter', 'description': 'Average Blood glucose measure', 'interventionNames': ['Other: No Device']}], 'interventions': [{'name': 'CGMS Device', 'type': 'DEVICE', 'otherNames': ['Continuing Glucose Monitoring Device'], 'armGroupLabels': ['Glucose Meter']}, {'name': 'No Device', 'type': 'OTHER', 'armGroupLabels': ['No Glucose Meter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Bonita Franklin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}