Ignite Creation Date:
2025-12-24 @ 2:02 PM
Ignite Modification Date:
2026-02-22 @ 7:23 PM
Study NCT ID:
NCT00657995
Status:
COMPLETED
Last Update Posted:
2008-04-14
First Post:
2008-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tight Glycemic Control by Artificial Pancreas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019397', 'term': 'Pancreas, Artificial'}], 'ancestors': [{'id': 'D001187', 'term': 'Artificial Organs'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-04-08', 'studyFirstSubmitDate': '2008-04-04', 'studyFirstSubmitQcDate': '2008-04-08', 'lastUpdatePostDateStruct': {'date': '2008-04-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the incidence of severe hypoglycemia (< 40 mg/dl) during the intensive care period following pancreatic resection in patients monitored using the artificial pancreas', 'timeFrame': 'the first postoperative 18 hours in the surgical intensive care unit'}], 'secondaryOutcomes': [{'measure': 'the total amount of insulin required for glycemic control after pancreatic resection', 'timeFrame': 'the first postoperative 18 hours in the surgical intensive care unit'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pancreatogenic', 'diabetes', 'artificial', 'pancreas'], 'conditions': ['Pancreatic Neoplasm']}, 'descriptionModule': {'briefSummary': 'This study evaluated a closed-loop system providing continuous monitoring and strict control of perioperative blood glucose following pancreatic resection.', 'detailedDescription': 'This study recruited 32 patients undergoing elective pancreatic resection for pancreatic disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* This study recruited 32 patients undergoing elective pancreatic resection for pancreatic disease.\n\nExclusion Criteria:\n\n* weight loss greater than 10% during the previous 6 months\n* signs of distant metastasis\n* respiratory, renal,or heart disease\n* Patients provided written informed consent prior to enrollment'}, 'identificationModule': {'nctId': 'NCT00657995', 'briefTitle': 'Tight Glycemic Control by Artificial Pancreas', 'organization': {'class': 'OTHER', 'fullName': 'Kochi University'}, 'officialTitle': 'Continuous Postoperative Blood Glucose Monitoring and Control by an Artificial Pancreas in Patients Undergoing Pancreatic Resection: A Prospective Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'TGC-AP-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Thirty patients who underwent pancreatic resection for pancreatic neoplasm were prospectively randomized. Perioperative blood glucose levels were continuously monitored using an artificial endocrine pancreas (STG-22). Glucose levels were controlled using either the sliding scale method or the artificial pancreas.', 'interventionNames': ['Device: Artificial Pancreas (STG-22)']}], 'interventions': [{'name': 'Artificial Pancreas (STG-22)', 'type': 'DEVICE', 'otherNames': ['STG-22; NIKKISO Corporation, Japan'], 'description': 'safe tool', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '783-8505', 'city': 'Nankoku', 'state': 'Kohasu-Okocho', 'country': 'Japan', 'facility': 'Kochi Medical School, Kochi University', 'geoPoint': {'lat': 33.56943, 'lon': 133.64937}}], 'overallOfficials': [{'name': 'Takehiro Okabayashi, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kochi Medical School, Kochi University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kochi University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Kochi Medical School/Department of Surgery', 'oldOrganization': 'Kochi University'}}}}