Insulin Pump Therapy and Continuous Glucose Monitoring in Diabetic Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Poor Glycemic Control |
Procedure: CSII and MDI |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
- Glycosylated hemoglobin (HbA1c) measurement [ Time Frame: 24 week follow-up ] [ Designated as safety issue: Yes ]
- The frequency of hypoglycemic episodes [ Time Frame: at 24 week follow-up ] [ Designated as safety issue: Yes ]Glycemic control, Glycosylated hemoglobin (HbA1c) measurement; Frequency of adverse events; Frequency of clinically significant abnormal laboratory values
| Estimated Enrollment: | 44 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: CSII
Optimized subcutaneous insulin infusion by means of continuous subcutaneous insulin infusion (CSII)
|
Procedure: 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.
|
|
No Intervention: MDI
MDI: Control Optimized subcutaneous insulin by multiple daily injections (MDI)
|
Procedure: 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.
|
Detailed Description:
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%.
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 18 - 70 years old at registration
- Type 1 or Type 2 Diabetic CAPD patients for at least 3 month and less than 60 months
- Hemoglobin A1c of at least 7.5% at registration Kt/V is greater than 1.7
Exclusion Criteria:
- Have peritonitis in recent 3 months other active bacterial infections
- Unstable clinical conditions or evidence of malignancy
- Pregnancy
- Non-diabetic ESRD patients
- Individuals already receiving diabetes therapy via an insulin pump
Contacts and Locations| Contact: Shi Wei, PHD | 8602083827812 ext 62027 | weishi_gz@126.com |
| Contact: Liu Shuangxin, PHD | 86020837812 ext 62027 | mplsxi@yahoo.com.cn |
| China, Guangdong | |
| Guangdong General Hospital | Recruiting |
| GuangZhou, Guangdong, China, 510080 | |
| Contact: Shi Wei, PHD 8602083827812 ext 62027 weishi_gz@126.com | |
| Contact: Liu Shuangxin, PHD 8602083827812 ext 62027 mplsxi@yahoo.com | |
| Principal Investigator: Shi Wei, PHD | |
| Study Director: | Shi Wei, PHD | Guangdong General Hospital |
More Information
No publications provided
| Responsible Party: | Division fo Nephrology, Guangdong General Hospital |
| ClinicalTrials.gov Identifier: | NCT01324557 History of Changes |
| Other Study ID Numbers: | InsulinPump |
| Study First Received: | March 9, 2011 |
| Last Updated: | March 28, 2011 |
| Health Authority: | China: Guangdong General Hospital Institutional Review Board |
Keywords provided by Guangdong General Hospital:
|
Continuous glucose monitoring CAPD patients Insulin pump |
Additional relevant MeSH terms:
|
Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013