Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT05548205
Status:
RECRUITING
Last Update Posted:
2025-10-02
First Post:
2022-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of 2-Week Continuous Glucose Monitoring on Glycemic Management in Patients New-to-Insulin on Hospital Discharge
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2022-09-16', 'studyFirstSubmitQcDate': '2022-09-16', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage Change in Hemoglobin A1c (HbA1c)', 'timeFrame': 'Baseline, Month 3 Post-Discharge', 'description': 'Assessed via CGM or BGM.'}], 'secondaryOutcomes': [{'measure': 'Number of Hospital Admissions', 'timeFrame': 'Up to Month 3 Post-Discharge'}, {'measure': 'Number of Emergency Department (ER) Visits', 'timeFrame': 'Up to Month 3 Post-Discharge'}, {'measure': 'Number of Hypoglycemic Events', 'timeFrame': 'Up to Month 3 Post-Discharge'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Continuous Glucose Monitoring (CGM)'], 'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'The proposed study will be a randomized, prospective, non-blinded study of 120 participants with type 1 or type 2 diabetes that are new-to-insulin on hospital discharge. On hospital discharge, participants will be assigned to either the intervention of wearing a continuous glucose monitor (CGM) for 2 weeks or blood glucose monitoring (BGM) for 2 weeks. They will have a 2-week follow up visit, during which insulin doses will be adjusted as needed, and a 3-month follow-up visit, at which point HbA1c will be measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female aged 18-100 years\n2. Known history of type 1 or type 2 diabetes\n3. Admitted to NYU Langone Hospital - Long Island between December 16, 2024- December 31, 2026\n4. New initiation of insulin therapy, including basal insulin regimen, basal-bolus insulin regimen, or mixed insulin regimen at the time of hospital discharge\n\nExclusion Criteria:\n\n1. Prior to admission use of home insulin therapy\n2. Current use of systemic corticosteroids\n3. Active pregnancy; as pregnancy requires different blood glucose targets, subjects known to be pregnant will be excluded from this study. Subjects will not be tested for pregnancy outside of testing performed in routine medical care; pregnancy will be determined by patient self-reporting. Females of childbearing potential will not be instructed to avoid pregnancy, however if they became pregnant during the study (detected by self-reporting), they will be withdrawn from the study.'}, 'identificationModule': {'nctId': 'NCT05548205', 'briefTitle': 'Effect of 2-Week Continuous Glucose Monitoring on Glycemic Management in Patients New-to-Insulin on Hospital Discharge', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Effect of 2-Week Continuous Glucose Monitoring on Glycemic Management in Patients New-to-Insulin on Hospital Discharge', 'orgStudyIdInfo': {'id': '22-01051'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Continuous Glucose Monitoring (CGM)', 'description': 'Patients in the CGM group will be instructed to wear a CGM uninterruptedly for 2 weeks duration.', 'interventionNames': ['Device: Continuous Glucose Monitor']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Blood Glucose Monitoring (BGM)', 'description': 'Patients in the BGM group will be instructed to check their blood glucose utilizing fingerstick glucose monitoring multiple times daily depending on their insulin regimen for 2 weeks duration.', 'interventionNames': ['Device: Blood Glucose Monitor']}], 'interventions': [{'name': 'Continuous Glucose Monitor', 'type': 'DEVICE', 'otherNames': ['Dexcom G7'], 'description': 'Manufactured by Abbott Diabetes Care Inc. Administered by trained investigator prior to hospital discharge, left in place for 2 weeks duration, then removed.', 'armGroupLabels': ['Continuous Glucose Monitoring (CGM)']}, {'name': 'Blood Glucose Monitor', 'type': 'DEVICE', 'description': 'Self-administered according to investigator instruction.', 'armGroupLabels': ['Blood Glucose Monitoring (BGM)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11501', 'city': 'Mineola', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael Goldstein', 'role': 'CONTACT', 'email': 'Michael.Goldstein@nyulangone.org', 'phone': '516-663-3511'}], 'facility': 'NYU Langone Hospital - Long Island', 'geoPoint': {'lat': 40.74927, 'lon': -73.64068}}], 'centralContacts': [{'name': 'Michael Goldstein', 'role': 'CONTACT', 'email': 'Michael.Goldstein@nyulangone.org', 'phone': '516-663-3511'}], 'overallOfficials': [{'name': 'Michael Goldstein', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Hospital - Long Island'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.', 'ipdSharing': 'YES', 'description': 'The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Stanislaw Klek (Stanislaw.Klek@nyulangone.org). The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.', 'accessCriteria': 'Requests should be directed to Stanislaw.Klek@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}