Insulin Pump Therapy and Continuous Glucose Monitoring in Diabetic Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients
NCT ID: NCT01324557
Last Updated: 2011-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
44 participants
INTERVENTIONAL
2011-03-31
2013-12-31
Brief Summary
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Detailed Description
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The 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.
Good 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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CSII
Optimized subcutaneous insulin infusion by means of continuous subcutaneous insulin infusion (CSII)
CSII and MDI
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.
MDI
MDI: Control Optimized subcutaneous insulin by multiple daily injections (MDI)
CSII and MDI
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.
Interventions
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CSII and MDI
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.
Eligibility Criteria
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Inclusion Criteria
2. Type 1 or Type 2 Diabetic CAPD patients for at least 3 month and less than 60 months
3. Hemoglobin A1c of at least 7.5% at registration Kt/V is greater than 1.7
Exclusion Criteria
2. Unstable clinical conditions or evidence of malignancy
3. Pregnancy
4. Non-diabetic ESRD patients
5. Individuals already receiving diabetes therapy via an insulin pump
18 Years
70 Years
ALL
No
Sponsors
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Guangdong Provincial People's Hospital
OTHER
Responsible Party
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Guangdong General Hospital
Principal Investigators
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Shi Wei, PHD
Role: STUDY_DIRECTOR
Guangdong Provincial People's Hospital
Locations
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Guangdong General Hospital
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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InsulinPump
Identifier Type: -
Identifier Source: org_study_id
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