Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT03544320
Status:
COMPLETED
Last Update Posted:
2019-08-29
First Post:
2018-05-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prediction Using Connected Technologies for Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018149', 'term': 'Glucose Intolerance'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The participants will be aware of the two different study arms and the wearable devices used in both. The study investigator will not have not have knowledge of the participants assigned to each arm.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are randomized to one of two wearable devices and will wear that device for the duration of the study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 186}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-28', 'studyFirstSubmitDate': '2018-05-18', 'studyFirstSubmitQcDate': '2018-05-18', 'lastUpdatePostDateStruct': {'date': '2019-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Hospitalization', 'timeFrame': '6 months', 'description': 'Admission to the hospital'}], 'primaryOutcomes': [{'measure': 'Change in hemoglobin A1c', 'timeFrame': '6 months', 'description': 'Change in hemoglobin A1c from baseline to 6 months'}], 'secondaryOutcomes': [{'measure': 'Change in low-density lipoprotein (LDL) levels', 'timeFrame': '6 months', 'description': 'Change in LDL level from baseline to 6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pre-diabetes', 'diabetes', 'wearable devices', 'mobile health'], 'conditions': ['Pre-Diabetes']}, 'descriptionModule': {'briefSummary': 'In this study, adults with pre-diabetes will be prospectively enrolled for data collection to design prediction models that integrate electronic health record data and patient-generated activity data. Patients will be randomized to receive either a waist-worn or wrist-worn wearable device for 6 months to capture patient-generated activity data.', 'detailedDescription': 'Patients with suboptimal glycemic control could be better managed if these higher risk patients could be identified and effective interventions were then targeted towards them. However, most practice settings perform infrequent laboratory testing every 3 to 6 months, if not at longer intervals. Current models to predict change in glycemic control perform poorly and do not take into account the behaviors that occur between these intervals. In this study, we will compare different methods to use data on daily health behaviors collected by wearable devices to enhance risk prediction models. Adults with pre-diabetes will complete a series of surveys and baseline assessments and then will be randomly assigned to use a waist-worn or wrist-worn wearable device for 6 months. Measures of HbA1c and LDL will be obtained at baseline and at 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Be 18 years or older\n2. Be able to provide informed consent\n3. Have a smartphone or tablet compatible with the wearable device smartphone application and be willing to use the wearable device for 6 months\n4. Baseline hemoglobin A1c of 5.7 to 6.4\n\nExclusion Criteria:\n\nParticipants will no be eligible if they have any medical condition or other reason that will likely prohibit them from completing the 6-month study'}, 'identificationModule': {'nctId': 'NCT03544320', 'acronym': 'PREDICT-DM', 'briefTitle': 'Prediction Using Connected Technologies for Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Prediction Using a Randomized Evaluation of Data Collection Integrated Through Connected Technologies for Diabetes Management', 'orgStudyIdInfo': {'id': '829150'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Activity Monitoring-Wrist worn wearable', 'description': 'Participants in the activity monitoring-wrist worn wearable group will be randomly assigned to track their activity using a Fitbit Charge 2 for 6 months.', 'interventionNames': ['Device: Activity Monitoring-Wrist worn wearable']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Activity Monitoring-Waist-worn wearable', 'description': 'Participants in the activity monitoring-waist worn wearable group will be randomly assigned to track their activity using a Fitbit Zip for 6 months.', 'interventionNames': ['Device: Activity Monitoring-Waist-worn wearable']}], 'interventions': [{'name': 'Activity Monitoring-Wrist worn wearable', 'type': 'DEVICE', 'description': 'Participants wear an activity monitor on their wrist.', 'armGroupLabels': ['Activity Monitoring-Wrist worn wearable']}, {'name': 'Activity Monitoring-Waist-worn wearable', 'type': 'DEVICE', 'description': 'Participants wear an activity monitor on their waist.', 'armGroupLabels': ['Activity Monitoring-Waist-worn wearable']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19103', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn Medicine', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Mitesh S Patel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}