Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2026-01-01 @ 9:36 PM
Study NCT ID:
NCT05360056
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-09
First Post:
2022-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Continuous Glucose Monitoring Following Hospital Discharge
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kathleen.dungan@osumc.edu', 'phone': '6146853333', 'title': 'Dr. Kathleen Dungan', 'organization': 'The Ohio State University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'description': 'Sensor adverse events include failure, bleeding, pain, infection and puritus', 'eventGroups': [{'id': 'EG000', 'title': 'Dexcom CGM', 'description': 'DexCom G6: Wearable continuous glucose monitor', 'otherNumAtRisk': 108, 'deathsNumAtRisk': 108, 'otherNumAffected': 30, 'seriousNumAtRisk': 108, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Sensor event', 'notes': 'Sensor related events including sensor failure, bleeding, pain, infection, or pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 40, 'numAffected': 30}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in TIR 70-180 mg/dl', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexcom CGM', 'description': 'DexCom G6: Wearable continuous glucose monitor'}], 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'spread': '28', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '8.51', 'pValueComment': 'unadjusted p-value', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '28.0', 'groupDescription': 'Paired t-test was performed comparing the %Time in range from 2 weeks to 12 weeks', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'paired t-test'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Change in %time in range between 70-180 mg/dl from 2 weeks to 12 weeks.', 'unitOfMeasure': 'percentage of time spent 70-180 mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '54 participants had data at 2 weeks and 12 weeks'}, {'type': 'PRIMARY', 'title': '% Wear Time >70%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexcom CGM', 'description': 'DexCom G6: Wearable continuous glucose monitor'}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': 'The number of participants with % wear time \\>70% will be reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '58 participants had CGM wear time at week 12'}, {'type': 'PRIMARY', 'title': 'DTSQc Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexcom CGM', 'description': 'DexCom G6: Wearable continuous glucose monitor'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '12'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Wilcoxon signed rank', 'paramValue': '9.85', 'statisticalMethod': 'paired Wilcoxon rank test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '12 weeks', 'description': 'The DTSQc compares the experience of the current treatment with the experience of the treatment before initiation of the study. Scores range from +3 ("much more satisfied now") to -3 ("much less satisfied now"), with 0 (midpoint) representing no change. Higher scores on the DTSQ total score indicate higher treatment satisfaction, and lower scores indicate lower treatment satisfaction. The total score ranges from -18 (maximum deterioration in satisfaction) to +18 (maximum improvement in satisfaction).A score of 0 indicates no change in satisfaction.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '61 participants had an available DTSQ change score at 12 weeks'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dexcom CGM', 'description': 'DexCom G6: Wearable continuous glucose monitor'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '108'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'primary endpoint, week 12', 'groupId': 'FG000', 'numSubjects': '66'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Dexcom CGM', 'description': 'DexCom G6: Wearable continuous glucose monitor'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '92', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.3', 'spread': '10.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '48', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '60', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '106', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '62', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '46', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '108', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline HbA1c', 'classes': [{'categories': [{'measurements': [{'value': '11.3', 'spread': '2.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage of glycosylated hemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-09-21', 'size': 720607, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-11-14T15:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2022-04-26', 'resultsFirstSubmitDate': '2025-10-16', 'studyFirstSubmitQcDate': '2022-05-03', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-12-08', 'studyFirstPostDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in TIR 70-180 mg/dl', 'timeFrame': '12 weeks', 'description': 'Change in %time in range between 70-180 mg/dl from 2 weeks to 12 weeks.'}, {'measure': '% Wear Time >70%', 'timeFrame': '12 weeks', 'description': 'The number of participants with % wear time \\>70% will be reported.'}, {'measure': 'DTSQc Score', 'timeFrame': '12 weeks', 'description': 'The DTSQc compares the experience of the current treatment with the experience of the treatment before initiation of the study. Scores range from +3 ("much more satisfied now") to -3 ("much less satisfied now"), with 0 (midpoint) representing no change. Higher scores on the DTSQ total score indicate higher treatment satisfaction, and lower scores indicate lower treatment satisfaction. The total score ranges from -18 (maximum deterioration in satisfaction) to +18 (maximum improvement in satisfaction).A score of 0 indicates no change in satisfaction.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'In this 12-week prospective observational cohort study, hospitalized insulin-requiring patients with T2D will receive a Dexcom continuous glucose monitor (CGM) to wear post-hospital discharge. Patients will complete surveys assessing patient-reported outcomes prior to CGM use and following completion of the study. CGM data will be captured by the patient smartphone app and analyzed. Patients will receive personalized CGM targets and alerts for hyperglycemia and hypoglycemia. Customized reports/ decision support will be sent to the usual diabetes provider. The initial observational cohort study design will be followed by an extension phase of 12 weeks in which data on continuation of use and glucose control will be collected but no further reports will be communicated to providers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 Diabetes\n* Basal insulin use \\>10 units per day\n* Hemoglobin A1c \\>8.0%\n* Smartphone compatible with Clarity App\n* Age ≥18 years\n\nExclusion Criteria:\n\n* Type 1 DM\n* Inability to consent\n* Pregnancy\n* Prisoners\n* Discharge to skilled nursing facility'}, 'identificationModule': {'nctId': 'NCT05360056', 'briefTitle': 'Continuous Glucose Monitoring Following Hospital Discharge', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Effect of Continuous Glucose Monitoring Following Hospital Discharge of Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': '2021H0426'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dexcom CGM', 'interventionNames': ['Device: DexCom G6']}], 'interventions': [{'name': 'DexCom G6', 'type': 'DEVICE', 'description': 'Wearable continuous glucose monitor', 'armGroupLabels': ['Dexcom CGM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43203', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Medical Center - Outpatient Care East', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Kathleen Dungan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OSU Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '• Availability of data and materials: In accordance with institution policy on sharing data and research resources, the final research data from this study may be made available for research purposes under a limited data use agreement specifying criteria for data access, conditions for research use, privacy and confidentiality standards to ensure data security and prohibitions for manipulating data for the purposes of identifying subjects.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kathleen Dungan', 'class': 'OTHER'}, 'collaborators': [{'name': 'DexCom, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Kathleen Dungan', 'investigatorAffiliation': 'Ohio State University'}}}}