Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-31 @ 10:37 PM
Study NCT ID:
NCT06921902
Status:
RECRUITING
Last Update Posted:
2025-04-10
First Post:
2025-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glycemic Metrics and Patterns in People With and Without Prediabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018149', 'term': 'Glucose Intolerance'}], 'ancestors': [{'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-04', 'studyFirstSubmitDate': '2025-04-04', 'studyFirstSubmitQcDate': '2025-04-04', 'lastUpdatePostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Characterize the glycemic profiles of people with and without a prediabetes diagnosis.', 'timeFrame': 'up to 50 days', 'description': 'This is a data collection study.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Pre Diabetes']}, 'descriptionModule': {'briefSummary': 'The FreeStyle Libre 3 Continuous Glucose Monitoring (FSL3) System is used to characterize the glycemic profiles of people with and without a prediabetes diagnosis.', 'detailedDescription': 'This is a non-pivotal, non-randomized, multi-center, prospective, non-significant risk to evaluate the glycemic profiles of people with and without a prediabetes diagnosis using continuous glucose monitoring. Up to 2000 subjects will be enrolled in up to 20 sites. Approximately 50% of evaluable subjects will have a prediabetes diagnosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects will be stratified into groups, including male and female sex, race, age and Body Mass Index. Approximately 25 evaluable subjects will be enrolled into each group.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject must be at least 18 years of age.\n* Subject must be willing and able to provide written signed and dated informed consent.\n\nExclusion Criteria:\n\n* Subject has a diagnosis of type 1 diabetes, type 2 diabetes, or gestational diabetes.\n* Subject is known to be currently practicing a low-carbohydrate or ketogenic diet at the time of enrollment.\n* Subject is known to be pregnant at the time of enrollment.\n* Subject has known allergy to medical grade adhesive, isopropyl alcohol and/or ethyl alcohol used to disinfect skin.\n* Subject is currently on any form of treatment indicated for the treatment of diabetes.\n* Subject is currently on any form of medication indicated for weight loss.'}, 'identificationModule': {'nctId': 'NCT06921902', 'acronym': 'PREMAP', 'briefTitle': 'Glycemic Metrics and Patterns in People With and Without Prediabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Diabetes Care'}, 'officialTitle': 'Observation and Identification of Glycemic Metrics and Patterns in People With and Without Prediabetes (PREMAP)', 'orgStudyIdInfo': {'id': 'ADC-US-RES-23243'}}, 'armsInterventionsModule': {'interventions': [{'name': 'FreeStyle Libre 3', 'type': 'DEVICE', 'otherNames': ['FreeStyle Libre 3 Monitoring System'], 'description': 'Abbott Sensor Based Glucose Monitoring System (FreeStyle Libre 3 System)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '97702', 'city': 'Bend', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Eden Miller, D.O.', 'role': 'CONTACT'}], 'facility': 'Diabetes and Obesity Care', 'geoPoint': {'lat': 44.05817, 'lon': -121.31531}}], 'centralContacts': [{'name': 'MOHAMED NADA, PhD', 'role': 'CONTACT', 'email': 'adc.clinical@abbott.com', 'phone': '5107495416'}], 'overallOfficials': [{'name': 'Shridhara Karinka, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Abbott Diabetes Care'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Diabetes Care', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}