Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-01-03 @ 10:17 PM
Study NCT ID:
NCT02345967
Status:
COMPLETED
Last Update Posted:
2018-06-13
First Post:
2015-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Function of Implanted Glucose Sensor 2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-11', 'studyFirstSubmitDate': '2015-01-20', 'studyFirstSubmitQcDate': '2015-01-23', 'lastUpdatePostDateStruct': {'date': '2018-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Adverse Events', 'timeFrame': 'From enrollment to 2-weeks post-explant', 'description': 'Incidence of adverse events related to the Intervention'}]}, 'conditionsModule': {'keywords': ['diabetes mellitus requiring insulin'], 'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to verify safety and assess tolerance of a long-term, implanted glucose monitoring sensor. The study will also provide data to characterize the response properties and calibration of the implanted sensor and determine if such properties vary with implant duration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Either: (1) male or (2) female and not pregnant, breastfeeding, or planning to become pregnant\n* Diabetes diagnosis of type 1, or type 2 using insulin\n* Under the routine care of a physician for diabetes treatment\n* Able to understand and follow directions\n* History of compliance with diabetes care regimen\n* Able to comply with study requirements regarding planned clinical visits and exams\n* In good physical condition without major medical concerns or blood chemistry abnormalities\n\nExclusion Criteria:\n\n* Mental disorders that might affect compliance to protocols\n* Diabetes diagnosis type 2 where treatment involves (1) oral medication without insulin or (2) insulin use restricted to a single daily injection of long-acting insulin or (3) control by diet/exercise regimen alone\n* History of intolerance or sensitivity to any of the device materials\n* History of any adverse reaction or allergy to any of the drugs/agents utilized in the study procedures\n* History of recurrent skin infections'}, 'identificationModule': {'nctId': 'NCT02345967', 'acronym': 'FIGS-2', 'briefTitle': 'Function of Implanted Glucose Sensor 2', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlySens Incorporated'}, 'officialTitle': 'Function of Implanted Glucose Sensor 2', 'orgStudyIdInfo': {'id': 'PR13-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study Group', 'description': 'Device: Model 100 Sensor', 'interventionNames': ['Device: Model 100 Sensor']}], 'interventions': [{'name': 'Model 100 Sensor', 'type': 'DEVICE', 'description': 'One Model 100 Sensor to be implanted per subject.', 'armGroupLabels': ['Study Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91911', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'Profil Institute for Clinical Research', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '92025', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'AMCR Institute', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}], 'overallOfficials': [{'name': 'Linda Morrow, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Profil Institute for Clinical Research, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlySens Incorporated', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Profil Institute for Clinical Research, Inc.', 'class': 'OTHER'}, {'name': 'AMCR Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}