Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
Study NCT ID:
NCT04161651
Status:
UNKNOWN
Last Update Posted:
2019-11-20
First Post:
2019-11-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Long-Term Implanted Sensor in Patients on Quality of Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-18', 'studyFirstSubmitDate': '2019-11-10', 'studyFirstSubmitQcDate': '2019-11-10', 'lastUpdatePostDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in quality of life evaluated questionnaires (DTSQ)', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Change in HBA1C', 'timeFrame': '3 / 6 months'}, {'measure': 'CGM Time In Range (70-180 mg/dl)', 'timeFrame': '3 / 6 months'}, {'measure': 'CGM Time in hypoglycaemia below 70 mg/dl', 'timeFrame': '3 / 6 months'}, {'measure': 'CGM Time in hypoglycaemia below 54 mg/dl', 'timeFrame': '3 / 6 months'}, {'measure': 'CGM time in range difference [2 weeks before digital visit and 2 weeks after digital visit]', 'timeFrame': '3 / 6 months'}, {'measure': 'Change in HFS-ii (hypoglycaemia fear survey II)', 'timeFrame': '6 months'}, {'measure': 'Change in Continuous Glucose Monitor Satisfaction Scale (CGM-SAT)', 'timeFrame': '6 months'}, {'measure': 'Any adverse event related to study device', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['eversense', 'type 1 diabetes'], 'conditions': ['Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': 'Evaluation of Long-Term Implanted Sensor in Patients on Quality of life', 'detailedDescription': 'Assess satisfaction and acceptance of long-term implanted single sensor use (eversense XL) for up to 6 months in type 1 insulin-using patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or Female diagnosed with type 1 diabetes mellitus\n2. Age \\> 18\n3. Insulin treatment for at least 1 year (Either MDI of CSII)\n4. HbA1c \\< 11%\n5. Signing informed consent and willing to apply with study procedure\n\nExclusion Criteria:\n\n1. History of severe hypoglycaemia in the last 3 months\n2. History of DKA in the last 3 months\n3. Any condition preventing or complicating the placement, operation or removal of the Sensor including upper extremity deformities or skin condition\n4. Female subjects of childbearing capacity (defined as not surgically sterile or not menopausal for ≥ 1 year) who are lactating or pregnant, intending to become pregnant, or not practicing birth control during the course of the study\n5. Any condition that require MRI imaging or planned MRI during the trial period\n6. Known topical or local anaesthetic allergy\n7. Known allergy to glucocorticoids\n8. History of hepatitis B, hepatitis C or HIV\n9. Any Bleeding disorder or taking anticoagulant medication\n10. Participation in other clinical trial\n11. Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol."}, 'identificationModule': {'nctId': 'NCT04161651', 'briefTitle': 'Evaluation of Long-Term Implanted Sensor in Patients on Quality of Life', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'officialTitle': 'Evaluation of Long-Term Implanted Sensor in Patients on Quality of Life', 'orgStudyIdInfo': {'id': '0047-19-COM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'single arm', 'interventionNames': ['Device: eversense']}], 'interventions': [{'name': 'eversense', 'type': 'DEVICE', 'description': 'eversense CGM', 'armGroupLabels': ['single arm']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meir Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'DYN Diagnostic LTD', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}