Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
Study NCT ID:
NCT06852950
Status:
RECRUITING
Last Update Posted:
2025-03-20
First Post:
2025-02-20
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Continuous Glucose Monitoring for Outpatient Diabetes Management After Hospital Discharge
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D006943', 'term': 'Hyperglycemia'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-17', 'studyFirstSubmitDate': '2025-02-20', 'studyFirstSubmitQcDate': '2025-02-24', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Questionnaire responses regarding patient satisfaction and opinion regarding use of continuous glucose monitoring system', 'timeFrame': 'From enrollment until follow-up telephone visit 2-3 weeks after discharge', 'description': "Questionnaire responses regarding patient satisfaction and opinion regarding use of continuous glucose monitoring system: regarding how do subjects feel that using CGM impacted their glucose control on a scale of 1-5, with 1=strongly made it worse, 2=somewhat made it worse, 3=did not make it better or worse, 4=somewhat made it better, and 5=strongly made it better?; regarding what is the overall opinion of subject's experience with CGM use on a scale of 1-5, with 1=very negative, 2=negative, 3=neutral, 4=positive, 5=very positive."}, {'measure': 'Questionnaire responses regarding patient satisfaction and opinion regarding quality of diabetes care', 'timeFrame': 'From enrollment until follow-up telephone visit 2-3 weeks after discharge', 'description': 'Questionnaire responses regarding patient satisfaction and opinion regarding quality of diabetes care: regarding how do subjects feel that using CGM impacted the diabetes care overall on a scale of 1-5, with 1=strongly made it worse, 2=somewhat made it worse, 3=did not make it better or worse, 4=somewhat made it better, and 5=strongly made it better.'}, {'measure': 'Questionnaire responses regarding patient familiarity with continuous glucose monitoring', 'timeFrame': 'From enrollment until follow-up telephone visit 2-3 weeks after discharge', 'description': "Questionnaire responses regarding patient familiarity with continuous glucose monitoring: regarding degree of familiarity of CGMs in general and the different types of information provided by CGMs, what is the subject's familiarity on a scale of 1-5, with 1=very unfamiliar, 2=unfamiliar, 3=neutral, 4=familiar, 5=very familiar."}], 'secondaryOutcomes': [{'measure': 'Degree of Average Change in Hemoglobin A1C from Start to End of Study', 'timeFrame': 'From enrollment until follow-up telephone visit 2-3 weeks after discharge', 'description': 'Degree of average change in Hemoglobin A1C from start to end of study'}, {'measure': 'Degree of Average Change in Glucose Management Indicator (GMI)', 'timeFrame': 'From enrollment until follow-up telephone visit 2-3 weeks after discharge', 'description': 'Degree of average change in glucose management indicator (GMI)'}, {'measure': 'Number of Participants with 30-day Readmissions Related to Glycemic Control', 'timeFrame': 'From enrollment until follow-up telephone visit 2-3 weeks after discharge', 'description': 'Number of participants with 30-day Readmissions Related to Glycemic Control (hyperglycemia, hypoglycemia, or diabetic ketoacidosis)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus (T2DM)', 'Type 1 Diabetes Mellitus (T1DM)', 'Hyperglycemia']}, 'descriptionModule': {'briefSummary': 'This study aims to improve patient awareness of the utility of continuous glucose monitoring systems in blood glucose monitoring and to improve patient satisfaction regarding diabetes care, particularly in the matter of blood glucose monitoring, at the transitions of care from the inpatient setting to the ambulatory setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Non-pregnant adults, ages greater than or equal to 18 years, admitted to VUMC\n* Able to give informed consent\n* Hyperglycemia requiring insulin therapy including subcutaneous insulin injection or continuous subcutaneous insulin infusion (patient's own insulin pump) during hospitalization and at the time of discharge\n* POC glucose or venous glucose levels in the 24 hours prior to participation need to be 70-350 mg/dL\n* Need glucose readings greater than or equal to one time per day\n* Mental status and dexterity adequate to use Libre 3 Plus or Dexcom G7 sensors with Libre 3 or Dexcom G7 application on patient's smartphone\n\nExclusion Criteria:\n\n* Currently using Libre 3 Plus or Dexcom G7 CGMS during hospitalization or have used Libre 3 Plus or Dexcom G7 CGMS in the past 3 months\n* Does not have smartphone compatible with Libre 3 App or Dexcom G7 App\n* Received chemotherapy during current hospitalization\n* Planning on major surgery within 10-15 days\n* Hemodialysis or peritoneal dialysis\n* Requiring vasopressors, intubation, sedation, or admission to an intensive care unit\n* Vitamin C use of more than 500 milligrams per day\n* Hydroxyurea use\n* Acetaminophen use of more than 4 grams per day or 1 gram every 6 hours\n* Significant pitting edema (3+ or greater) i.e. cirrhosis with ascites, congestive heart failure with edema, nephrotic syndrome, or signs of poor perfusion\n* Presentation in diabetic ketoacidosis or hyperosmotic nonketotic state\n* Skin allergy to adhesives"}, 'identificationModule': {'nctId': 'NCT06852950', 'briefTitle': 'Continuous Glucose Monitoring for Outpatient Diabetes Management After Hospital Discharge', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Continuous Glucose Monitoring for Outpatient Diabetes Management After Hospital Discharge', 'orgStudyIdInfo': {'id': '242071'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Libre 3 Plus Continuous Glucose Monitor', 'description': 'Subjects in this arm will start using the Libre 3 Plus continuous glucose monitor.', 'interventionNames': ['Device: Libre 3 Plus Continuous Glucose Monitor']}, {'type': 'EXPERIMENTAL', 'label': 'Dexcom G7 Continuous Glucose Monitor', 'description': 'Subjects in this arm will start using the Dexcom G7 continuous glucose monitor.', 'interventionNames': ['Device: Dexcom G7 Continuous Glucose Monitor']}], 'interventions': [{'name': 'Libre 3 Plus Continuous Glucose Monitor', 'type': 'DEVICE', 'description': 'Subjects in this arm will start using the Libre 3 Plus continuous glucose monitor.', 'armGroupLabels': ['Libre 3 Plus Continuous Glucose Monitor']}, {'name': 'Dexcom G7 Continuous Glucose Monitor', 'type': 'DEVICE', 'description': 'Subjects in this arm will start using the Dexcom G7 continuous glucose monitor.', 'armGroupLabels': ['Dexcom G7 Continuous Glucose Monitor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Angel Morvant, MD', 'role': 'CONTACT', 'email': 'angel.morvant@vumc.org', 'phone': '(615) 343-8332'}, {'name': 'Angel Morvant, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'centralContacts': [{'name': 'Angel Morvant, MD', 'role': 'CONTACT', 'email': 'angel.morvant@vumc.org', 'phone': '615-343-8332'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Angel Morvant', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}