Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-26 @ 1:13 PM
Study NCT ID:
NCT04879693
Status:
UNKNOWN
Last Update Posted:
2021-05-10
First Post:
2021-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness and Safety of the Dexcom G6 Continuous Glucose Monitoring System in Non-Critically Ill Patients in the Inpatient Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000095583', 'term': 'Continuous Glucose Monitoring'}], 'ancestors': [{'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003940', 'term': 'Diagnostic Techniques, Endocrine'}, {'id': 'D008991', 'term': 'Monitoring, Physiologic'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'All systems worn will be blinded. All sensor insertions will be performed at the clinic by subjects and/or caregivers.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-07', 'studyFirstSubmitDate': '2021-05-05', 'studyFirstSubmitQcDate': '2021-05-07', 'lastUpdatePostDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'System Performance', 'timeFrame': 'Up to 10 days', 'description': 'Assess the performance of the CGM System in comparison to a blood glucose comparator method in non-critically ill hospitalized patients who need glucose control.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Patients Needing Glucose Control']}, 'descriptionModule': {'briefSummary': 'Effectiveness and Safety of the Dexcom G6 Continuous Glucose Monitoring System in Non-Critically Ill Patients in the Inpatient Setting', 'detailedDescription': 'To assess the performance of the CGM System in comparison to a blood glucose comparator method in non-critically ill hospitalized patients who need glucose control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age and older\n* Admitted to the hospital in a non-ICU bed or once transferred out of ICU\n* Anticipate at least 48 hours of hospital stay\n* On treatment for glucose control.\n* Willingness to complete the study.\n* Willingness to wear up to 3 CGM systems simultaneously. Two in the abdomen and one on the back of the arm or one on each arm and one on the abdomen.\n* Subject and/or caretaker are able to speak, read, and write English\n\nExclusion Criteria:\n\n* Presence of extensive skin changes/diseases at sensor wear site(s) that preclude wearing the sensor(s) on normal skin (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis)\n* Currently in an intensive care unit (ICU) of the following type (does not apply to participants placed in an ICU bed due to space issues in the non-ICU areas)\n* Known allergy to medical-grade adhesives\n* Pregnancy, demonstrated by a positive test (for subjects of childbearing potential)\n* Women admitted to give birth or any other admission related to pregnancy\n* Patients receiving Hydroxyurea\n* Bleeding disorder\n* Participants that are currently being treated for malignancies, cancer\n* Participant that are hospitalized to receive an organ transplant\n* Require a Magnetic Resonance Imaging (MRI) scan\n* End stage renal disease and currently managed by dialysis or anticipating initiating dialysis during the study wear period\n* Current participation in another investigational study protocol (If a subject has recently completed participation in another drug study, the subject must have completed that study at least 7 days prior to being enrolled in this study.)\n* Any condition that, in the opinion of the Investigator, would interfere with their participation in the trial or pose an excessive risk to study staff (e.g., known history of hepatitis B or C)'}, 'identificationModule': {'nctId': 'NCT04879693', 'briefTitle': 'Effectiveness and Safety of the Dexcom G6 Continuous Glucose Monitoring System in Non-Critically Ill Patients in the Inpatient Setting', 'organization': {'class': 'INDUSTRY', 'fullName': 'DexCom, Inc.'}, 'officialTitle': 'Effectiveness and Safety of the Dexcom G6 Continuous Glucose Monitoring System in Non-Critically Ill Patients in the Inpatient Setting', 'orgStudyIdInfo': {'id': 'PTL-904283'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hospitalized Patients', 'description': 'To assess performance of CGM compared to comparator measurement.', 'interventionNames': ['Device: Continuous Glucose Monitoring System']}], 'interventions': [{'name': 'Continuous Glucose Monitoring System', 'type': 'DEVICE', 'description': 'Continuous Glucose Monitoring System', 'armGroupLabels': ['Hospitalized Patients']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Stayce Beck, PhD, MPH', 'role': 'CONTACT', 'email': 'PTL904283@dexcom.com', 'phone': '858-203-6454'}, {'name': 'Kathleen Hurst', 'role': 'CONTACT', 'email': 'PTL904283@dexcom.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DexCom, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}