Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-30 @ 4:36 AM
Study NCT ID:
NCT01324557
Status:
UNKNOWN
Last Update Posted:
2011-03-29
First Post:
2011-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Insulin Pump Therapy and Continuous Glucose Monitoring in Diabetic Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-03-28', 'studyFirstSubmitDate': '2011-03-09', 'studyFirstSubmitQcDate': '2011-03-28', 'lastUpdatePostDateStruct': {'date': '2011-03-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycosylated hemoglobin (HbA1c) measurement', 'timeFrame': '24 week follow-up'}], 'secondaryOutcomes': [{'measure': 'The frequency of hypoglycemic episodes', 'timeFrame': 'at 24 week follow-up', 'description': 'Glycemic control, Glycosylated hemoglobin (HbA1c) measurement; Frequency of adverse events; Frequency of clinically significant abnormal laboratory values'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Continuous glucose monitoring', 'CAPD patients', 'Insulin pump'], 'conditions': ['Diabetes', 'Poor Glycemic Control']}, 'descriptionModule': {'briefSummary': 'The aims of this study are to assess the potential efficacy and safety of insulin pump to improve glycemic control in conjunction with continuous glucose monitoring (CGMS) for diabetic continuous ambulatory peritoneal dialysis (CAPD) patients.', 'detailedDescription': 'Diabetic nephropathy now accounts for 20% to 40% of all patients entering end-stage renal failure (ESRF) programs. The quality of glycemic control is known to be an important determinant of the rate of progression of patients with diabetic continuous ambulatory peritoneal dialysis (CAPD) patients. Diabetic CAPD patients are usually treated with dialysis fluids utilizing glucose as the osmotic agent to provide ultrafiltration. Most of diabetic CAPD patients had HbA1c readings above 7% despite the recommendation to keep the reading below 7%.\n\nThe continuous blood glucose monitor (CGMS) has recently offered an opportunity to monitor blood glucose at 5-minute intervals for 72 continuous hours in diabetic patients. The CGMS patterns reveal blood glucose tracings well above the recommended standards of control in most of the diabetic CAPD patients.\n\nGood glycemic control is often difficult to maintain in diabetic patients treated with CAPD because they are continuously exposed to high concentrations of glucose in peritoneal dialysate. However, recent studies have suggested that diabetic patients who use insulin pump has been shown to reduce glycated hemoglobin levels without an increased risk of hypoglycemia, as compared with a regimen of multiple daily insulin injections, but results in diabetic CAPD patients have not been reported.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 - 70 years old at registration\n2. Type 1 or Type 2 Diabetic CAPD patients for at least 3 month and less than 60 months\n3. Hemoglobin A1c of at least 7.5% at registration Kt/V is greater than 1.7\n\nExclusion Criteria:\n\n1. Have peritonitis in recent 3 months other active bacterial infections\n2. Unstable clinical conditions or evidence of malignancy\n3. Pregnancy\n4. Non-diabetic ESRD patients\n5. Individuals already receiving diabetes therapy via an insulin pump'}, 'identificationModule': {'nctId': 'NCT01324557', 'briefTitle': 'Insulin Pump Therapy and Continuous Glucose Monitoring in Diabetic Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients', 'organization': {'class': 'OTHER', 'fullName': "Guangdong Provincial People's Hospital"}, 'orgStudyIdInfo': {'id': 'InsulinPump'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CSII', 'description': 'Optimized subcutaneous insulin infusion by means of continuous subcutaneous insulin infusion (CSII)', 'interventionNames': ['Procedure: CSII and MDI']}, {'type': 'NO_INTERVENTION', 'label': 'MDI', 'description': 'MDI: Control Optimized subcutaneous insulin by multiple daily injections (MDI)', 'interventionNames': ['Procedure: CSII and MDI']}], 'interventions': [{'name': 'CSII and MDI', 'type': 'PROCEDURE', 'description': 'The aims of this study are to assess the potential efficacy and safety of insulin pump(MiniMed Paradigm® REAL-Time Revel™ Insulin Pump) to improve glycemic control in conjunction with continuous glucose monitoring (CGMS) for diabetic CAPD Patients.', 'armGroupLabels': ['CSII', 'MDI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shi Wei, PHD', 'role': 'CONTACT', 'email': 'weishi_gz@126.com', 'phone': '8602083827812', 'phoneExt': '62027'}, {'name': 'Liu Shuangxin, PHD', 'role': 'CONTACT', 'email': 'mplsxi@yahoo.com', 'phone': '8602083827812', 'phoneExt': '62027'}, {'name': 'Shi Wei, PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Guangdong General Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Shi Wei, PHD', 'role': 'CONTACT', 'email': 'weishi_gz@126.com', 'phone': '8602083827812', 'phoneExt': '62027'}, {'name': 'Liu Shuangxin, PHD', 'role': 'CONTACT', 'email': 'mplsxi@yahoo.com.cn', 'phone': '86020837812', 'phoneExt': '62027'}], 'overallOfficials': [{'name': 'Shi Wei, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Guangdong Provincial People's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guangdong Provincial People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Division fo Nephrology', 'oldOrganization': 'Guangdong General Hospital'}}}}