Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2026-01-01 @ 5:53 PM
Study NCT ID:
NCT05992350
Status:
TERMINATED
Last Update Posted:
2025-10-17
First Post:
2023-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Garmin PACT (Physical Activity Tracking in Type 1 Diabetes Using Garmin Vivosmart)
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': 'Endocrine-RisingT1deAlliance@cmh.edu', 'phone': '8166014543', 'title': 'Priscilla Connell', 'organization': "Children's Mercy Research Institute"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'Only adverse events were monitored for youth as parents only completed Hypoglycemic Fear Scale II for Parents (HFS-P) for the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Primary Analysis Arm', 'description': 'Youth (8-21 YO) diagnosed with T1D.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 3, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Moderate to Vigorous Physical Activity (MVPA) Amount', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Analysis Arm', 'description': 'Youth (8-21 YO) diagnosed with T1D'}], 'timeFrame': 'Up to 365 days +- 30 days', 'description': 'Minutes per Day of MVPA', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.'}, {'type': 'PRIMARY', 'title': 'Diabetic Ketoacidosis (DKA) Admission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Analysis Arm', 'description': 'Youth (8-21 YO) diagnosed with T1D'}], 'timeFrame': '90 days +- 30 days', 'description': 'Rate of hospitalization for diabetic ketoacidosis', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.'}, {'type': 'PRIMARY', 'title': 'Diabetic Ketoacidosis (DKA) Admission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Analysis Arm', 'description': 'Youth (8-21 YO) diagnosed with T1D'}], 'timeFrame': '180 days +- 30 days', 'description': 'Rate of hospitalization for diabetic ketoacidosis', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.'}, {'type': 'PRIMARY', 'title': 'Diabetic Ketoacidosis (DKA) Admission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Analysis Arm', 'description': 'Youth (8-21 YO) diagnosed with T1D'}], 'timeFrame': '365 +-30 days', 'description': 'Rate of hospitalization for diabetic ketoacidosis', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.'}, {'type': 'PRIMARY', 'title': 'Change in Time in Range', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Analysis Arm', 'description': 'Youth (8-21 YO) diagnosed with T1D'}], 'timeFrame': 'Over 90, 180, and 365 +- 30 days', 'description': 'Time where blood glucose is in an appropriate range (and other glucose measurements)', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.'}, {'type': 'PRIMARY', 'title': 'Predicted Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Analysis Arm', 'description': 'Youth (8-21 YO) diagnosed with T1D'}], 'timeFrame': '90 +- 30 days', 'description': 'machine learning models to predict change in HbA1c, DKA admissions, and change in Time in Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.'}, {'type': 'PRIMARY', 'title': 'Predicted Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Analysis Arm', 'description': 'Youth (8-21 YO) diagnosed with T1D'}], 'timeFrame': '180 +- 30 days', 'description': 'machine learning models to predict change in HbA1c, DKA admissions, and change in Time in Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.'}, {'type': 'PRIMARY', 'title': 'Predicted Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Analysis Arm', 'description': 'Youth (8-21 YO) diagnosed with T1D'}], 'timeFrame': '365 +- 30 days', 'description': 'machine learning models to predict change in HbA1c, DKA admissions, and change in Time in Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.'}, {'type': 'PRIMARY', 'title': 'Minutes of Sleep Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Analysis Arm', 'description': 'Youth (8-21 YO) diagnosed with T1D'}], 'timeFrame': 'Up to 365 days +- 30 days', 'description': 'Minutes of Sleep per Day', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.'}, {'type': 'SECONDARY', 'title': 'Self Reported Physical Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Analysis Arm', 'description': 'Youth (8-21 YO) diagnosed with T1D'}], 'timeFrame': '0 months', 'description': 'Self-reported physical activity via the International Physical Activity Questionnaire Short Form (IPAQ-SF), no min or max, recording the amount of time spent in MVPA in the past week, higher amounts are better.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.'}, {'type': 'SECONDARY', 'title': 'Self Reported Physical Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Analysis Arm', 'description': 'Youth (8-21 YO) diagnosed with T1D'}], 'timeFrame': '6 months', 'description': 'Self-reported physical activity via the International Physical Activity Questionnaire Short Form (IPAQ- SF), no min or max, recording the amount of time spent in MVPA in the past week, higher amounts are better.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.'}, {'type': 'SECONDARY', 'title': 'Self Reported Physical Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Analysis Arm', 'description': 'Youth (8-21 YO) diagnosed with T1D'}], 'timeFrame': '12 months', 'description': 'Self-reported physical activity via the International Physical Activity Questionnaire Short Form (IPAQ-SF), no min or max, recording the amount of time spent in MVPA in the past week higher amounts are better.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.'}, {'type': 'SECONDARY', 'title': 'Self Reported T1D Management', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Analysis Arm', 'description': 'Youth (8-21 YO) diagnosed with T1D'}], 'timeFrame': '0 months', 'description': 'Hypoglycemic Fear Scale (HFS-II) min 0 max 132, higher scores are a worse outcome', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.'}, {'type': 'SECONDARY', 'title': 'Self Reported T1D Management', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Analysis Arm', 'description': 'Youth (8-21 YO) diagnosed with T1D'}], 'timeFrame': '6 months', 'description': 'Hypoglycemic Fear Scale (HFS-II) min 0 max 132, higher scores are a worse outcome', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.'}, {'type': 'SECONDARY', 'title': 'Self Reported T1D Management', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Analysis Arm', 'description': 'Youth (8-21 YO) diagnosed with T1D'}], 'timeFrame': '12 months', 'description': 'Hypoglycemic Fear Scale (HFS-II) min 0 max 132, higher scores are a worse outcome', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.'}, {'type': 'SECONDARY', 'title': 'Self Reported T1D Management', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Analysis Arm', 'description': 'Parents of youth (8-21 YO) diagnosed with T1D'}], 'timeFrame': '0 months', 'description': 'Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, higher scores are a worse outcome', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.'}, {'type': 'SECONDARY', 'title': 'Self Reported T1D Management', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Analysis Arm', 'description': 'Youth (8-21 YO) diagnosed with T1D'}], 'timeFrame': '6 months', 'description': 'Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, higher scores are a worse outcome', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.'}, {'type': 'SECONDARY', 'title': 'Self Reported T1D Management', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Analysis Arm', 'description': 'Parents of youth (8-21 YO) diagnosed with T1D'}], 'timeFrame': '12 months', 'description': 'Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, higher scores are a worse outcome', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.'}, {'type': 'SECONDARY', 'title': 'Change in Self Reported Physical Activity Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Analysis Arm', 'description': 'Youth (8-21 YO) diagnosed with T1D'}], 'timeFrame': 'Between 0, 6, and 12 months', 'description': 'Change in self reported physical activity levels via self-report with the IPAQ survey no min or max, recording the amount of time spent in MVPA in the past week, higher amounts are better.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.'}, {'type': 'SECONDARY', 'title': 'Change in How Participants Feel About Episodes of Hypoglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Analysis Arm', 'description': 'Youth (8-21 YO) diagnosed with T1D'}], 'timeFrame': 'Between 0, 6, and 12 months', 'description': 'Change in how participants feel about episodes of hypoglycemia measured via the Hypoglycemic Fear Scale II (HFS-II) min 0 max 132, higher scores are a worse outcome', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.'}, {'type': 'SECONDARY', 'title': 'Change in How Parents Feel About Episodes of Hypoglycemia in Their Children', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Analysis Arm', 'description': 'Parents of youth (8-21 YO) diagnosed with T1D'}], 'timeFrame': 'Between 0, 6, and 12 months', 'description': 'Change in how parents feel about episodes of hypoglycemia in their children wearing the Garmin physical activity tracker via the Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, higher scores are a worse outcome', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Primary Analysis Arm', 'description': 'Youth (8-21 YO) diagnosed with T1D.'}, {'id': 'FG001', 'title': 'Parent Arm', 'description': 'Parents of youth (8-18YO) diagnosed with T1D.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '21'}]}]}], 'preAssignmentDetails': 'Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Primary Analysis Arm', 'description': 'Youth (8-21 YO) diagnosed with T1D'}, {'id': 'BG001', 'title': 'Parent Arm', 'description': 'Parents of youth (8-18 YO) diagnosed with T1D'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P).'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P).'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P).'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P).'}], 'populationDescription': 'Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-03-11', 'size': 1587821, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-07-31T13:12', 'hasProtocol': True}, {'date': '2025-01-10', 'size': 1660099, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-07-31T13:12', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Staffing shortages', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2023-05-23', 'resultsFirstSubmitDate': '2025-07-14', 'studyFirstSubmitQcDate': '2023-08-07', 'lastUpdatePostDateStruct': {'date': '2025-10-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-30', 'studyFirstPostDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Moderate to Vigorous Physical Activity (MVPA) Amount', 'timeFrame': 'Up to 365 days +- 30 days', 'description': 'Minutes per Day of MVPA'}, {'measure': 'Diabetic Ketoacidosis (DKA) Admission', 'timeFrame': '90 days +- 30 days', 'description': 'Rate of hospitalization for diabetic ketoacidosis'}, {'measure': 'Diabetic Ketoacidosis (DKA) Admission', 'timeFrame': '180 days +- 30 days', 'description': 'Rate of hospitalization for diabetic ketoacidosis'}, {'measure': 'Diabetic Ketoacidosis (DKA) Admission', 'timeFrame': '365 +-30 days', 'description': 'Rate of hospitalization for diabetic ketoacidosis'}, {'measure': 'Change in Time in Range', 'timeFrame': 'Over 90, 180, and 365 +- 30 days', 'description': 'Time where blood glucose is in an appropriate range (and other glucose measurements)'}, {'measure': 'Predicted Change', 'timeFrame': '90 +- 30 days', 'description': 'machine learning models to predict change in HbA1c, DKA admissions, and change in Time in Range'}, {'measure': 'Predicted Change', 'timeFrame': '180 +- 30 days', 'description': 'machine learning models to predict change in HbA1c, DKA admissions, and change in Time in Range'}, {'measure': 'Predicted Change', 'timeFrame': '365 +- 30 days', 'description': 'machine learning models to predict change in HbA1c, DKA admissions, and change in Time in Range'}, {'measure': 'Minutes of Sleep Per Day', 'timeFrame': 'Up to 365 days +- 30 days', 'description': 'Minutes of Sleep per Day'}], 'secondaryOutcomes': [{'measure': 'Self Reported Physical Activity', 'timeFrame': '0 months', 'description': 'Self-reported physical activity via the International Physical Activity Questionnaire Short Form (IPAQ-SF), no min or max, recording the amount of time spent in MVPA in the past week, higher amounts are better.'}, {'measure': 'Self Reported Physical Activity', 'timeFrame': '6 months', 'description': 'Self-reported physical activity via the International Physical Activity Questionnaire Short Form (IPAQ- SF), no min or max, recording the amount of time spent in MVPA in the past week, higher amounts are better.'}, {'measure': 'Self Reported Physical Activity', 'timeFrame': '12 months', 'description': 'Self-reported physical activity via the International Physical Activity Questionnaire Short Form (IPAQ-SF), no min or max, recording the amount of time spent in MVPA in the past week higher amounts are better.'}, {'measure': 'Self Reported T1D Management', 'timeFrame': '0 months', 'description': 'Hypoglycemic Fear Scale (HFS-II) min 0 max 132, higher scores are a worse outcome'}, {'measure': 'Self Reported T1D Management', 'timeFrame': '6 months', 'description': 'Hypoglycemic Fear Scale (HFS-II) min 0 max 132, higher scores are a worse outcome'}, {'measure': 'Self Reported T1D Management', 'timeFrame': '12 months', 'description': 'Hypoglycemic Fear Scale (HFS-II) min 0 max 132, higher scores are a worse outcome'}, {'measure': 'Self Reported T1D Management', 'timeFrame': '0 months', 'description': 'Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, higher scores are a worse outcome'}, {'measure': 'Self Reported T1D Management', 'timeFrame': '6 months', 'description': 'Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, higher scores are a worse outcome'}, {'measure': 'Self Reported T1D Management', 'timeFrame': '12 months', 'description': 'Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, higher scores are a worse outcome'}, {'measure': 'Change in Self Reported Physical Activity Levels', 'timeFrame': 'Between 0, 6, and 12 months', 'description': 'Change in self reported physical activity levels via self-report with the IPAQ survey no min or max, recording the amount of time spent in MVPA in the past week, higher amounts are better.'}, {'measure': 'Change in How Participants Feel About Episodes of Hypoglycemia', 'timeFrame': 'Between 0, 6, and 12 months', 'description': 'Change in how participants feel about episodes of hypoglycemia measured via the Hypoglycemic Fear Scale II (HFS-II) min 0 max 132, higher scores are a worse outcome'}, {'measure': 'Change in How Parents Feel About Episodes of Hypoglycemia in Their Children', 'timeFrame': 'Between 0, 6, and 12 months', 'description': 'Change in how parents feel about episodes of hypoglycemia in their children wearing the Garmin physical activity tracker via the Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, higher scores are a worse outcome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes']}, 'referencesModule': {'references': [{'pmid': '34346318', 'type': 'BACKGROUND', 'citation': 'Cescon M, Choudhary D, Pinsker JE, Dadlani V, Church MM, Kudva YC, Doyle Iii FJ, Dassau E. Activity detection and classification from wristband accelerometer data collected on people with type 1 diabetes in free-living conditions. Comput Biol Med. 2021 Aug;135:104633. doi: 10.1016/j.compbiomed.2021.104633. Epub 2021 Jul 12.'}, {'pmid': '35297778', 'type': 'BACKGROUND', 'citation': 'Grimes A, Lightner JS, Eighmy K, Steel C, Shook RP, Carlson J. Decreased Physical Activity Among Youth Resulting From COVID-19 Pandemic-Related School Closures: Natural Experimental Study. JMIR Form Res. 2022 Apr 15;6(4):e35854. doi: 10.2196/35854.'}, {'pmid': '34682355', 'type': 'BACKGROUND', 'citation': 'Jaggers JR, McKay T, King KM, Thrasher BJ, Wintergerst KA. Integration of Consumer-Based Activity Monitors into Clinical Practice for Children with Type 1 Diabetes: A Feasibility Study. Int J Environ Res Public Health. 2021 Oct 10;18(20):10611. doi: 10.3390/ijerph182010611.'}, {'pmid': '32105515', 'type': 'BACKGROUND', 'citation': 'Ozaslan B, Patek SD, Breton MD. Impact of Daily Physical Activity as Measured by Commonly Available Wearables on Mealtime Glucose Control in Type 1 Diabetes. Diabetes Technol Ther. 2020 Oct;22(10):742-748. doi: 10.1089/dia.2019.0517.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to test the Garmin Vivosmart in children and youth (8-21) with Type 1 Diabetes (T1D) and their parents. The main questions it aims to answer are:\n\n* Does the Garmin Vivosmart increase physical activity (PA)?\n* Does the Garmin Vivosmart improve T1D status\n\nParticipants will:\n\n* Wear the Garmin Vivosmart (4 or higher) for a year\n* Complete surveys at the beginning, middle and end of participation asking about your T1D, T1D management, and PA\n* Parents of children will also complete similar surveys about T1D'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Youth (8-21 YO) diagnosed with T1D and parents of youth (8-17 YO)', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants aged 8-21 years of age and/or parent of participant aged 8-17 years of age\n* Participants diagnosed with T1D greater than 6 months ago\n* Participants must be patients at the Children's Mercy Kansas City network\n\nExclusion Criteria:\n\n* Participants who do not meet age criteria above\n* Participants who do not have T1D\n* Participants who are unwilling to wear the device for at least 6 months"}, 'identificationModule': {'nctId': 'NCT05992350', 'briefTitle': 'Garmin PACT (Physical Activity Tracking in Type 1 Diabetes Using Garmin Vivosmart)', 'organization': {'class': 'OTHER', 'fullName': "Children's Mercy Hospital Kansas City"}, 'officialTitle': 'Garmin PACT (Physical Activity Tracking)', 'orgStudyIdInfo': {'id': 'STUDY00002582'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Garmin physical activity tracker', 'type': 'OTHER', 'description': 'The Garmin physical activity tracker is worn like a watch on the user. The tracker assesses several physical states, indicates when the body is at optimal time for activity or when the body needs to rest. The tracker also monitors stress levels and prompts relaxation when appropriate. The tracker sets goals with participants based on previously completed activity. The tracker alerts participants after a period of inactivity, encourages regular movement throughout the day, and decreases the amount of time spent sedentary.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}], 'overallOfficials': [{'name': 'Mark Clements, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Mercy"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Mercy Hospital Kansas City", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}