Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT04854135
Status:
TERMINATED
Last Update Posted:
2024-02-16
First Post:
2021-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Continuous Glucose Monitoring Initiation at Hospital Discharge
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-07-05', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D007003', 'term': 'Hypoglycemia'}], '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': 'pcruz@wustl.edu', 'phone': '314-922-8620', 'title': 'Paulina Cruz Bravo, MD', 'organization': 'Washington University in St. Louis'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'CGM Intervention', 'description': 'All eligible patients will receive a Continuous Glucose Monitor (CGM) prior to hospital discharge after signing an informed consent.\n\nCGM4Home: FreeStyle Libre 2 Continuous Glucose Monitoring System manufactured by Abbott', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'To Determine the Feasibility of Initiating a Continuous Glucose Monitoring in Patients With Diabetes at Hospital Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM Intervention', 'description': 'All eligible patients will receive a Continuous Glucose Monitor (CGM) prior to hospital discharge after signing an informed consent.\n\nCGM4Home: FreeStyle Libre 2 Continuous Glucose Monitoring System manufactured by Abbott'}], 'classes': [{'categories': [{'title': 'Lost to follow up', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Discontinued use at 3 months', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Continued use at 3 months', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 3 months', 'description': 'Starting and continuing to use a CGM at this critical time is feasible. Feasibility is defined as at least 20 percent of patients with diabetes referred for diabetes education meet inclusion criteria to participate and at least 75 percent participate. From those who participate, at least 50 percent continue using the CGM at 3 months.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients That Discontinue the CGM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Discontinued Use', 'description': 'at 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 6 months', 'description': 'Discontinuation rate, measured by percentage of patients that discontinue the CGM at 6 months with wearing device, use, costs, getting refills, etc.)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants lost to follow up were counted as discontinued'}, {'type': 'SECONDARY', 'title': 'Mean Time in Range Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM Intervention', 'description': 'All eligible patients will receive a Continuous Glucose Monitor (CGM) prior to hospital discharge after signing an informed consent.\n\nCGM4Home: FreeStyle Libre 2 Continuous Glucose Monitoring System manufactured by Abbott'}], 'timeFrame': 'At 1 month and 3 months', 'description': 'Mean and SD of Time below target, in target and above target at 1 month and 3 months', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected'}, {'type': 'SECONDARY', 'title': 'Mean Change in Self-efficacy at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM Intervention Baseline', 'description': 'All eligible patients will receive a Continuous Glucose Monitor (CGM) prior to hospital discharge after signing an informed consent.\n\nCGM4Home: FreeStyle Libre 2 Continuous Glucose Monitoring System manufactured by Abbott'}, {'id': 'OG001', 'title': '3-month', 'description': 'All eligible patients will receive a Continuous Glucose Monitor (CGM) prior to hospital discharge after signing an informed consent.\n\nCGM4Home: FreeStyle Libre 2 Continuous Glucose Monitoring System manufactured by Abbott'}], 'classes': [{'categories': [{'measurements': [{'value': '30.66', 'spread': '8.2', 'groupId': 'OG000'}, {'value': '40.8', 'spread': '7.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 months', 'description': 'Using the Diabetes self-management Questionnaire (DMSQ), the investigators will measure the mean change and SD in the score (pre- and post- intervention)\n\nscore is 0-48, higher scores mean a better outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CGM Intervention', 'description': 'All eligible patients will receive a Continuous Glucose Monitor (CGM) prior to hospital discharge after signing an informed consent.\n\nCGM4Home: FreeStyle Libre 2 Continuous Glucose Monitoring System manufactured by Abbott'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'CGM Intervention', 'description': 'All eligible patients will receive a Continuous Glucose Monitor (CGM) prior to hospital discharge after signing an informed consent.\n\nCGM4Home: FreeStyle Libre 2 Continuous Glucose Monitoring System manufactured by Abbott'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49', 'spread': '13.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black Non Hispanic', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'White, Non Hispanic', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic/Latino', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Black Non Hispanic White Non Hispanic Hispanic/Latino', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-02-02', 'size': 201117, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-11-19T11:19', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'whyStopped': 'High drop out rate', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-04-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-15', 'studyFirstSubmitDate': '2021-04-14', 'resultsFirstSubmitDate': '2023-06-13', 'studyFirstSubmitQcDate': '2021-04-20', 'lastUpdatePostDateStruct': {'date': '2024-02-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-15', 'studyFirstPostDateStruct': {'date': '2021-04-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To Determine the Feasibility of Initiating a Continuous Glucose Monitoring in Patients With Diabetes at Hospital Discharge', 'timeFrame': 'At 3 months', 'description': 'Starting and continuing to use a CGM at this critical time is feasible. Feasibility is defined as at least 20 percent of patients with diabetes referred for diabetes education meet inclusion criteria to participate and at least 75 percent participate. From those who participate, at least 50 percent continue using the CGM at 3 months.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients That Discontinue the CGM', 'timeFrame': 'At 6 months', 'description': 'Discontinuation rate, measured by percentage of patients that discontinue the CGM at 6 months with wearing device, use, costs, getting refills, etc.)'}, {'measure': 'Mean Time in Range Outcomes', 'timeFrame': 'At 1 month and 3 months', 'description': 'Mean and SD of Time below target, in target and above target at 1 month and 3 months'}, {'measure': 'Mean Change in Self-efficacy at 3 Months', 'timeFrame': 'Baseline and 3 months', 'description': 'Using the Diabetes self-management Questionnaire (DMSQ), the investigators will measure the mean change and SD in the score (pre- and post- intervention)\n\nscore is 0-48, higher scores mean a better outcome'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Type 1 Diabetes', 'Type2 Diabetes', 'Hyperglycemia', 'Hypoglycemia', 'Hypoglycemia Unawareness']}, 'referencesModule': {'references': [{'pmid': '15251567', 'type': 'BACKGROUND', 'citation': 'Graber AL, Davidson FA, Brown MS, Gaume JA, McRae MD, Wolff K. Hospitalization of patients with diabetes. Endocr Pract. 1995 Nov-Dec;1(6):399-403. doi: 10.4158/EP.1.6.399.'}, {'pmid': '31740472', 'type': 'BACKGROUND', 'citation': 'Mattishent K, Lane K, Salter C, Dhatariya K, May HM, Neupane S, Loke YK. Continuous glucose monitoring in older people with diabetes and memory problems: a mixed-methods feasibility study in the UK. BMJ Open. 2019 Nov 18;9(11):e032037. doi: 10.1136/bmjopen-2019-032037.'}, {'pmid': '11889147', 'type': 'BACKGROUND', 'citation': 'Umpierrez GE, Isaacs SD, Bazargan N, You X, Thaler LM, Kitabchi AE. Hyperglycemia: an independent marker of in-hospital mortality in patients with undiagnosed diabetes. J Clin Endocrinol Metab. 2002 Mar;87(3):978-82. doi: 10.1210/jcem.87.3.8341.'}, {'pmid': '28828487', 'type': 'BACKGROUND', 'citation': 'Beck RW, Riddlesworth TD, Ruedy K, Ahmann A, Haller S, Kruger D, McGill JB, Polonsky W, Price D, Aronoff S, Aronson R, Toschi E, Kollman C, Bergenstal R; DIAMOND Study Group. Continuous Glucose Monitoring Versus Usual Care in Patients With Type 2 Diabetes Receiving Multiple Daily Insulin Injections: A Randomized Trial. Ann Intern Med. 2017 Sep 19;167(6):365-374. doi: 10.7326/M16-2855. Epub 2017 Aug 22.'}, {'pmid': '21722581', 'type': 'BACKGROUND', 'citation': 'Ehrhardt NM, Chellappa M, Walker MS, Fonda SJ, Vigersky RA. The effect of real-time continuous glucose monitoring on glycemic control in patients with type 2 diabetes mellitus. J Diabetes Sci Technol. 2011 May 1;5(3):668-75. doi: 10.1177/193229681100500320.'}, {'pmid': '18701183', 'type': 'BACKGROUND', 'citation': 'Yoo HJ, An HG, Park SY, Ryu OH, Kim HY, Seo JA, Hong EG, Shin DH, Kim YH, Kim SG, Choi KM, Park IB, Yu JM, Baik SH. Use of a real time continuous glucose monitoring system as a motivational device for poorly controlled type 2 diabetes. Diabetes Res Clin Pract. 2008 Oct;82(1):73-9. doi: 10.1016/j.diabres.2008.06.015. Epub 2008 Aug 12.'}, {'pmid': '31661077', 'type': 'BACKGROUND', 'citation': 'Whelan ME, Orme MW, Kingsnorth AP, Sherar LB, Denton FL, Esliger DW. Examining the Use of Glucose and Physical Activity Self-Monitoring Technologies in Individuals at Moderate to High Risk of Developing Type 2 Diabetes: Randomized Trial. JMIR Mhealth Uhealth. 2019 Oct 28;7(10):e14195. doi: 10.2196/14195.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to look at feasibility (the likelihood) of continued use of the FreeStyle Libre 2 Continuous glucose monitor (CGM) when started at the time of hospital discharge in patients with poorly controlled diabetes and to look at the effects of CGM use on blood glucose control and quality of life. Additional information will be collected to determine the barriers to continuing CGM use after discharge. The investigators will also collect information to see how well blood glucose has been controlled after discharge while utilizing the CGM.', 'detailedDescription': 'VISIT/PHONE CALL WHAT WILL HAPPEN? (estimated time) \\[window\\]\n\nScreening Visit (\\~45 minutes) Review consent form and obtain consent Complete questionnaire, obtain diabetes history Day of Discharge (\\~1 hour) Complete FreeStyle Libre 2 CGM education Attach FreeStyle Libre 2 CGM sensor to arm Within 1-3 weeks from discharge Phone Call (\\~30 minutes) Questions regarding use of FreeStyle Libre 2 CGM Current diabetes regimen Adverse Events Reminder to take FreeStyle Libre 2 CGM sensor prescription to pharmacy to be filled\n\n1 \\& 3 Month Phone Call (\\~45 minutes) \\[+/- 5 days\\] Questions regarding use of FreeStyle Libre 2 CGM Current diabetes regimen Complete questionnaire Adverse Events 6 Month Phone Call (\\~15 minutes) \\[+/- 10 days\\] Questions regarding use of FreeStyle Libre 2 CGM Barriers to FreeStyle Libre 2 CGM use\n\nValidated Instruments: Diabetes self-management Questionnaire (DMSQ)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. 18 years of age or older\n2. Have diabetes (type 1 diabetes mellitus, type 2 diabetes mellitus, cystic fibrosis related diabetes mellitus)\n3. Hemoglobin A1c greater than or equal to 8.0% or history of hypoglycemia unawareness\n4. Able and willing to sign informed consent form\n5. Have a valid telephone number\n6. Willing to purchase FreeStyle Libre 2 CGM sensors out of pocket after discharge from hospital (when insurance coverage isn't available)\n\nExclusion Criteria:\n\n1. Unable to sign informed consent form\n2. Have altered mental status\n3. Unable to manage diabetes independently at home\n4. Have utilized CGM in the past\n5. Pregnancy\n6. New steroid-induced hyperglycemia\n7. Unwilling to participate in the study\n8. Have kidney disease requiring hemodialysis\n9. Taking high doses of vitamin C daily (greater than 500 mg every day)"}, 'identificationModule': {'nctId': 'NCT04854135', 'acronym': 'CGM4Home', 'briefTitle': 'Continuous Glucose Monitoring Initiation at Hospital Discharge', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Continuous Glucose Monitoring Initiation at Hospital Discharge: A Feasibility Pilot Study', 'orgStudyIdInfo': {'id': '202101175'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CGM Intervention', 'description': 'All eligible patients will receive a Continuous Glucose Monitor (CGM) prior to hospital discharge after signing an informed consent.', 'interventionNames': ['Device: CGM4Home']}], 'interventions': [{'name': 'CGM4Home', 'type': 'DEVICE', 'description': 'FreeStyle Libre 2 Continuous Glucose Monitoring System manufactured by Abbott', 'armGroupLabels': ['CGM Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Barnes Jewish Hospital/ Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Paulina Cruz Bravo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Paulina Cruz Bravo', 'investigatorAffiliation': 'Washington University School of Medicine'}}}}