Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:55 PM
Study NCT ID:
NCT05074667
Status:
COMPLETED
Last Update Posted:
2024-07-31
First Post:
2021-09-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Use of Continuous Glucose Monitors in Publicly-Insured Youth With Type 2 Diabetes - A Pilot and Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sshah2@stanford.edu', 'phone': '650-498-7351', 'title': 'Sejal Shah, MD', 'organization': 'Stanford University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '12 months', 'eventGroups': [{'id': 'EG000', 'title': 'Continuous Glucose Monitor', 'description': 'Participants are provided a continuous glucose monitor for use in self-glucose monitoring as per standard clinical care. Participants and their parents are asked to complete patient reported outcome questionnaires at 3 study time points.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With at Least 75% Wear Time Over 14 Days as a Measure of Sustained CGM Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Continuous Glucose Monitor', 'description': 'Participants are provided a continuous glucose monitor for use in self-glucose monitoring as per standard clinical care. Participants and their parents are asked to complete patient reported outcome questionnaires at 3 study time points.'}], 'classes': [{'title': '2-month visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': '3-month visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': '6-month visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '9-month visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '12-month visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'months 2,3,6,9 and 12 (assessed over the 14 days prior to each clinic visit)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available CGM data at each respective timepoint'}, {'type': 'SECONDARY', 'title': 'Mean HbA1C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Continuous Glucose Monitor', 'description': 'Participants are provided a continuous glucose monitor for use in self-glucose monitoring as per standard clinical care. Participants and their parents are asked to complete patient reported outcome questionnaires at 3 study time points.'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.18', 'spread': '2.65', 'groupId': 'OG000'}]}]}, {'title': '2-month visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.16', 'spread': '2.69', 'groupId': 'OG000'}]}]}, {'title': '3-month visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.95', 'spread': '2.91', 'groupId': 'OG000'}]}]}, {'title': '6-month visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.27', 'spread': '2.71', 'groupId': 'OG000'}]}]}, {'title': '9-month visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.04', 'spread': '2.214', 'groupId': 'OG000'}]}]}, {'title': '12-month visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.77', 'spread': '1.22', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and months 2,3,6,9 and 12', 'description': 'HbA1C through 12 months of CGM use', 'unitOfMeasure': 'percentage of glycosylated hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data at each respective timepoint'}, {'type': 'SECONDARY', 'title': 'Time With Glucose Values in Target Range of 70-180 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Continuous Glucose Monitor', 'description': 'Participants are provided a continuous glucose monitor for use in self-glucose monitoring as per standard clinical care. Participants and their parents are asked to complete patient reported outcome questionnaires at 3 study time points.'}], 'classes': [{'title': '2-month visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '93.25'}]}]}, {'title': '3-month visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '45.5', 'groupId': 'OG000', 'lowerLimit': '11.25', 'upperLimit': '87.75'}]}]}, {'title': '6-month visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000', 'lowerLimit': '37', 'upperLimit': '86'}]}]}, {'title': '9-month visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28.5', 'groupId': 'OG000', 'lowerLimit': '7.5', 'upperLimit': '53.75'}]}]}, {'title': '12-month visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000', 'lowerLimit': '31', 'upperLimit': '77'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'months 2,3,6,9 and 12 (assessed over the 14 days prior to each clinic visit)', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available CGM data at each respective timepoint'}, {'type': 'SECONDARY', 'title': 'PROMIS Global Health Overall Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Continuous Glucose Monitor', 'description': 'Participants are provided a continuous glucose monitor for use in self-glucose monitoring as per standard clinical care. Participants and their parents are asked to complete patient reported outcome questionnaires at 3 study time points.'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '37.20', 'groupId': 'OG000', 'lowerLimit': '30.00', 'upperLimit': '40.40'}]}]}, {'title': '3-month visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35.60', 'groupId': 'OG000', 'lowerLimit': '32.40', 'upperLimit': '38.80'}]}]}, {'title': '12-month visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '32.40', 'groupId': 'OG000', 'lowerLimit': '29.20', 'upperLimit': '35.60'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline, months 3 and 12', 'description': 'PROMIS Global Health (7 questions, Minimum=1, maximum=5 for each question, higher score for physical health questions is better outcome, higher score for mental health is worse outcome). Scores for each question were summed then converted to a t-score (overall range 16 to 67.5, higher score = better health). A score of 50 is the average for the United States general population with a standard deviation of 10. A score below 22 in this study would result in a referral to social work or diabetes psychology.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data at each respective timepoint'}, {'type': 'SECONDARY', 'title': 'PedsQL 3.2 Overall Scale Score - Participant Rated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Continuous Glucose Monitor', 'description': 'Participants are provided a continuous glucose monitor for use in self-glucose monitoring as per standard clinical care. Participants and their parents are asked to complete patient reported outcome questionnaires at 3 study time points.'}], 'classes': [{'title': 'Peds QL Diabetes - baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '58.33', 'groupId': 'OG000', 'lowerLimit': '50.00', 'upperLimit': '71.67'}]}]}, {'title': 'Peds QL Diabetes - month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '65.00', 'groupId': 'OG000', 'lowerLimit': '55.83', 'upperLimit': '72.92'}]}]}, {'title': 'Peds QL Diabetes - month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '58.33', 'groupId': 'OG000', 'lowerLimit': '45.00', 'upperLimit': '69.58'}]}]}, {'title': 'Peds QL Overall - baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '65.53', 'groupId': 'OG000', 'lowerLimit': '58.33', 'upperLimit': '71.97'}]}]}, {'title': 'Peds QL Overall - month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '59.85', 'groupId': 'OG000', 'lowerLimit': '56.82', 'upperLimit': '72.92'}]}]}, {'title': 'Peds QL Overall - month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '55.30', 'groupId': 'OG000', 'lowerLimit': '52.84', 'upperLimit': '65.72'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline and months 3 and 12', 'description': 'Pediatric Quality of Life Inventory (PedsQL) Diabetes Module version 3.2, including 33 items (questions) comprising 5 dimensions (diabetes symptoms, treatment 1, treatment 2, worry, and communication). Each item scored from 0 to 4, higher scores correspond to lower problems. Each item is reversed scored and linearly transformed to a 0 to 100 scale (0=100,1=75,2=50,3=25,4=0), higher scores correspond to lower problems. The overall score is calculated as the sum of the transformed scores for each item divided by the total number of items answered by participants to create an overall score range of 0 to 100, higher scores correspond to lower problems.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data at each respective timepoint'}, {'type': 'SECONDARY', 'title': 'PedsQL 3.2 Scale Score - Parent Rated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Continuous Glucose Monitor', 'description': 'Participants are provided a continuous glucose monitor for use in self-glucose monitoring as per standard clinical care. Participants and their parents are asked to complete patient reported outcome questionnaires at 3 study time points.'}], 'classes': [{'title': 'Peds QL Diabetes - baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '65.00', 'groupId': 'OG000', 'lowerLimit': '61.67', 'upperLimit': '73.33'}]}]}, {'title': 'Peds QL Diabetes - month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '60.00', 'groupId': 'OG000', 'lowerLimit': '55.83', 'upperLimit': '68.33'}]}]}, {'title': 'Peds QL Diabetes - month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '59.17', 'groupId': 'OG000', 'lowerLimit': '54.58', 'upperLimit': '72.08'}]}]}, {'title': 'Peds QL Overall - baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '64.39', 'groupId': 'OG000', 'lowerLimit': '56.06', 'upperLimit': '70.76'}]}]}, {'title': 'Peds QL Overall - month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '59.85', 'groupId': 'OG000', 'lowerLimit': '50.76', 'upperLimit': '68.94'}]}]}, {'title': 'Peds QL Overall - month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '57.58', 'groupId': 'OG000', 'lowerLimit': '52.84', 'upperLimit': '73.86'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline and months 3 and 12', 'description': 'Pediatric Quality of Life Inventory (PedsQL) Diabetes Module version 3.2, including 33 items (questions) comprising 5 dimensions (diabetes symptoms, treatment 1, treatment 2, worry, and communication). Each item scored from 0 to 4, higher scores correspond to lower problems. Each item is reversed scored and linearly transformed to a 0 to 100 scale (0=100,1=75,2=50,3=25,4=0), higher scores correspond to lower problems. The overall score is calculated as the sum of the transformed scores for each item divided by the total number of items answered by parents to create an overall score range of 0 to 100, higher scores correspond to lower problems. Parents completed the survey at the same time as their child but were not considered to be enrolled in the study.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data at each respective timepoint'}, {'type': 'SECONDARY', 'title': 'Diabetes Technology Attitudes (DTA) - Participant Rated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Continuous Glucose Monitor', 'description': 'Participants are provided a continuous glucose monitor for use in self-glucose monitoring as per standard clinical care. Participants and their parents are asked to complete patient reported outcome questionnaires at 3 study time points.'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.78', 'groupId': 'OG000', 'lowerLimit': '3.55', 'upperLimit': '4.25'}]}]}, {'title': '3-month visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.50', 'groupId': 'OG000', 'lowerLimit': '3.65', 'upperLimit': '4.95'}]}]}, {'title': '12-month visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.00', 'groupId': 'OG000', 'lowerLimit': '3.75', 'upperLimit': '4.55'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 year (assessed at baseline, 3 months and 12 months)', 'description': 'The DTA assesses use and comfort with technology. Each of the 5 items are responded to on a 5 point likert scale (from 1=Strongly Disagree to 5=Strongly Agree) Mean item score, higher score = more positive attitude, total score range 1-5', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data at each respective timepoint'}, {'type': 'SECONDARY', 'title': 'Diabetes Technology Attitudes (DTA) - Parent Rated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Continuous Glucose Monitor', 'description': 'Participants are provided a continuous glucose monitor for use in self-glucose monitoring as per standard clinical care. Participants and their parents are asked to complete patient reported outcome questionnaires at 3 study time points.'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.80', 'groupId': 'OG000', 'lowerLimit': '3.40', 'upperLimit': '3.80'}]}]}, {'title': '3-month visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.00', 'groupId': 'OG000', 'lowerLimit': '3.60', 'upperLimit': '4.50'}]}]}, {'title': '12-month visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.60', 'groupId': 'OG000', 'lowerLimit': '3.35', 'upperLimit': '4.05'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 year (assessed at baseline, 3 months and 12 months)', 'description': 'The DTA assesses use and comfort with technology. Each of the 5 items are responded to on a 5 point likert scale (from 1=Strongly Disagree to 5=Strongly Agree) Mean item score, higher score = more positive attitude, total score range 1-5 Parents completed the survey at the same time as their child but were not considered to be enrolled in the study.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data at each respective timepoint'}, {'type': 'SECONDARY', 'title': 'Problem Areas in Diabetes-Teen Version (PAID-T) Overall Scale Score - Participant Rated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Continuous Glucose Monitor', 'description': 'Participants are provided a continuous glucose monitor for use in self-glucose monitoring as per standard clinical care. Participants and their parents are asked to complete patient reported outcome questionnaires at 3 study time points.'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '43.50', 'groupId': 'OG000', 'lowerLimit': '30.75', 'upperLimit': '47.00'}]}]}, {'title': '3-month visit', 'categories': [{'measurements': [{'value': '47.00', 'groupId': 'OG000', 'lowerLimit': '34.25', 'upperLimit': '62.50'}]}]}, {'title': '12-month visit', 'categories': [{'measurements': [{'value': '52.00', 'groupId': 'OG000', 'lowerLimit': '40.50', 'upperLimit': '60.50'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline, months 3 and 12', 'description': 'Problem Areas in Diabetes - survey Teen version with 14 questions each scored using a 6-point Likert Scale (1=not a problem, to 6=serious problem). The overall score is computed by summing responses for an overall range of 14 to 84 (higher score is worse outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the PAID Teen survey'}, {'type': 'SECONDARY', 'title': 'Problem Areas in Diabetes (P-PAID) Overall Scale Score - Parent Rated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Continuous Glucose Monitor', 'description': 'Participants are provided a continuous glucose monitor for use in self-glucose monitoring as per standard clinical care. Participants and their parents are asked to complete patient reported outcome questionnaires at 3 study time points.'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '55.00', 'groupId': 'OG000', 'lowerLimit': '46.00', 'upperLimit': '69.50'}]}]}, {'title': '3-month visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '59.00', 'groupId': 'OG000', 'lowerLimit': '48.50', 'upperLimit': '69.00'}]}]}, {'title': '12-month visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.50', 'groupId': 'OG000', 'lowerLimit': '42.75', 'upperLimit': '68.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline, months 3 and 12', 'description': 'Problem Areas in Diabetes - survey Teen Parent version with 15 questions each scored using a 6-point Likert Scale (1=not a problem, to 6=serious problem). The overall score is computed by summing responses for an overall range of 15 to 90 (higher score is worse outcome). Parents completed the survey at the same time as their child but were not considered to be enrolled in the study.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data at each respective timepoint'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Continuous Glucose Monitor', 'description': 'Participants are provided a continuous glucose monitor for use in self-glucose monitoring as per standard clinical care. Participants and their parents are asked to complete patient reported outcome questionnaires at 3 study time points.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Continuous Glucose Monitor', 'description': 'Participants are provided a continuous glucose monitor for use in self-glucose monitoring as per standard clinical care. Participants and their parents are asked to complete patient reported outcome questionnaires at 3 study time points.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '15.19', 'spread': '2.48', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian and Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}, {'title': 'Non Hispanic Black', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Non Hispanic White', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-18', 'size': 459787, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-06-07T11:02', 'hasProtocol': True}, {'date': '2022-01-13', 'size': 304228, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-10-12T00:53', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-06-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-09', 'studyFirstSubmitDate': '2021-09-29', 'resultsFirstSubmitDate': '2024-06-08', 'studyFirstSubmitQcDate': '2021-09-29', 'lastUpdatePostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-09', 'studyFirstPostDateStruct': {'date': '2021-10-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With at Least 75% Wear Time Over 14 Days as a Measure of Sustained CGM Use', 'timeFrame': 'months 2,3,6,9 and 12 (assessed over the 14 days prior to each clinic visit)'}], 'secondaryOutcomes': [{'measure': 'Mean HbA1C', 'timeFrame': 'baseline and months 2,3,6,9 and 12', 'description': 'HbA1C through 12 months of CGM use'}, {'measure': 'Time With Glucose Values in Target Range of 70-180 mg/dL', 'timeFrame': 'months 2,3,6,9 and 12 (assessed over the 14 days prior to each clinic visit)'}, {'measure': 'PROMIS Global Health Overall Scale Score', 'timeFrame': 'baseline, months 3 and 12', 'description': 'PROMIS Global Health (7 questions, Minimum=1, maximum=5 for each question, higher score for physical health questions is better outcome, higher score for mental health is worse outcome). Scores for each question were summed then converted to a t-score (overall range 16 to 67.5, higher score = better health). A score of 50 is the average for the United States general population with a standard deviation of 10. A score below 22 in this study would result in a referral to social work or diabetes psychology.'}, {'measure': 'PedsQL 3.2 Overall Scale Score - Participant Rated', 'timeFrame': 'baseline and months 3 and 12', 'description': 'Pediatric Quality of Life Inventory (PedsQL) Diabetes Module version 3.2, including 33 items (questions) comprising 5 dimensions (diabetes symptoms, treatment 1, treatment 2, worry, and communication). Each item scored from 0 to 4, higher scores correspond to lower problems. Each item is reversed scored and linearly transformed to a 0 to 100 scale (0=100,1=75,2=50,3=25,4=0), higher scores correspond to lower problems. The overall score is calculated as the sum of the transformed scores for each item divided by the total number of items answered by participants to create an overall score range of 0 to 100, higher scores correspond to lower problems.'}, {'measure': 'PedsQL 3.2 Scale Score - Parent Rated', 'timeFrame': 'baseline and months 3 and 12', 'description': 'Pediatric Quality of Life Inventory (PedsQL) Diabetes Module version 3.2, including 33 items (questions) comprising 5 dimensions (diabetes symptoms, treatment 1, treatment 2, worry, and communication). Each item scored from 0 to 4, higher scores correspond to lower problems. Each item is reversed scored and linearly transformed to a 0 to 100 scale (0=100,1=75,2=50,3=25,4=0), higher scores correspond to lower problems. The overall score is calculated as the sum of the transformed scores for each item divided by the total number of items answered by parents to create an overall score range of 0 to 100, higher scores correspond to lower problems. Parents completed the survey at the same time as their child but were not considered to be enrolled in the study.'}, {'measure': 'Diabetes Technology Attitudes (DTA) - Participant Rated', 'timeFrame': '1 year (assessed at baseline, 3 months and 12 months)', 'description': 'The DTA assesses use and comfort with technology. Each of the 5 items are responded to on a 5 point likert scale (from 1=Strongly Disagree to 5=Strongly Agree) Mean item score, higher score = more positive attitude, total score range 1-5'}, {'measure': 'Diabetes Technology Attitudes (DTA) - Parent Rated', 'timeFrame': '1 year (assessed at baseline, 3 months and 12 months)', 'description': 'The DTA assesses use and comfort with technology. Each of the 5 items are responded to on a 5 point likert scale (from 1=Strongly Disagree to 5=Strongly Agree) Mean item score, higher score = more positive attitude, total score range 1-5 Parents completed the survey at the same time as their child but were not considered to be enrolled in the study.'}, {'measure': 'Problem Areas in Diabetes-Teen Version (PAID-T) Overall Scale Score - Participant Rated', 'timeFrame': 'baseline, months 3 and 12', 'description': 'Problem Areas in Diabetes - survey Teen version with 14 questions each scored using a 6-point Likert Scale (1=not a problem, to 6=serious problem). The overall score is computed by summing responses for an overall range of 14 to 84 (higher score is worse outcome).'}, {'measure': 'Problem Areas in Diabetes (P-PAID) Overall Scale Score - Parent Rated', 'timeFrame': 'baseline, months 3 and 12', 'description': 'Problem Areas in Diabetes - survey Teen Parent version with 15 questions each scored using a 6-point Likert Scale (1=not a problem, to 6=serious problem). The overall score is computed by summing responses for an overall range of 15 to 90 (higher score is worse outcome). Parents completed the survey at the same time as their child but were not considered to be enrolled in the study.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '40974209', 'type': 'DERIVED', 'citation': 'Shah S, Tanenbaum ML, Loyola A, Sala NGL, Darji H, Hanes S, Bishop FK, Hood KK, Maahs DM. Use of Continuous Glucose Monitors in Publicly Insured Youth With Type 2 Diabetes: A 12-month Pilot and Feasibility Study. J Diabetes Sci Technol. 2025 Sep 20:19322968251368366. doi: 10.1177/19322968251368366. Online ahead of print.'}], 'seeAlsoLinks': [{'url': 'https://www.healthmeasures.net/images/PROMIS/manuals/Scoring_Manuals_/PROMIS_Global_Health_Scoring_Manual.pdf', 'label': 'PROMIS scoring manual'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this pilot feasibility study is to provide continued CGM access to youth with type 2 diabetes and collect descriptive data about feasibility of use of CGM in youth with type 2 diabetes ages 4 years and older. From this study the investigators hope to learn if CGM use in youth with type 2 diabetes can be tolerated and sustained with good adherence and to describe blood glucose patterns in youth with type 2 diabetes. The primary aim will be to evaluate the feasibility of CGM start and continuation in youth with T2D and describe glucose metrics and patient reported outcomes (PROs). The investigators will pilot and refine a program to test the hypothesis that CGM start and continuation in youth with T2D is feasible and then evaluate glucose metrics and PROs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* public insurance\n* between ages 4-19.99 years inclusive\n* diagnosis of T2D (diabetes autoantibody negative) followed in the Pediatric Endocrinology clinic at Stanford Children's Health\n* HbA1C greater than 6.5% at enrollment\n* interested in starting on a continuous glucose monitor\n* have access to a mobile device that is compatible with CGM applications or willing to use CGM receiver provided\n\nExclusion Criteria:\n\n* non-T2D diagnosis\n* HgA1C \\< 6.5%\n* are not willing to wear CGM\n* have private health insurance."}, 'identificationModule': {'nctId': 'NCT05074667', 'briefTitle': 'Use of Continuous Glucose Monitors in Publicly-Insured Youth With Type 2 Diabetes - A Pilot and Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Use of Continuous Glucose Monitors in Publicly-Insured Youth With Type 2 Diabetes - A Pilot and Feasibility Study', 'orgStudyIdInfo': {'id': '62166'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Continuous Glucose Monitor', 'description': 'All participants will be included in this arm', 'interventionNames': ['Device: Continuous Glucose Monitor', 'Other: Patient Reported Outcome Questionnaires']}], 'interventions': [{'name': 'Continuous Glucose Monitor', 'type': 'DEVICE', 'description': 'Participants will be provided a continuous glucose monitor for use in self-glucose monitoring as per standard clinical care', 'armGroupLabels': ['Continuous Glucose Monitor']}, {'name': 'Patient Reported Outcome Questionnaires', 'type': 'OTHER', 'description': 'Participants and their parents will be asked to complete patient reported outcome questionnaires at 3 study time points.', 'armGroupLabels': ['Continuous Glucose Monitor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': "Stanford Children's Health", 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'overallOfficials': [{'name': 'Sejal Shah, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'immediately following publication. No end date.', 'ipdSharing': 'YES', 'description': 'All of the individual participant data collected during the trial after deidentification', 'accessCriteria': 'Researchers who provide a methodologically sound proposal, for purpose of achieving aims in the approved proposal. Proposals should be directed to the protocol director and data sharing requests will need to follow current protocols in place at Stanford University.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor of Pediatrics', 'investigatorFullName': 'Sejal Shah', 'investigatorAffiliation': 'Stanford University'}}}}