Insulin Pump Therapy and Continuous Glucose Monitoring in Diabetic Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes; Poor Glycemic Control
• Intervention / Treatment: Procedure: CSII and MDI

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.

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Shi Wei, PHD; Phone Number: 62027 8602083827812; Email: weishi_gz@126.com
• Study Contact Backup: Name: Liu Shuangxin, PHD; Phone Number: 62027 86020837812; Email: mplsxi@yahoo.com.cn

Study Locations

• China
  • Guangdong
    • GuangZhou, Guangdong, China, 510080
      • Recruiting
      • Guangdong General Hospital
      • Contact: Shi Wei, PHD; Phone Number: 62027 8602083827812; Email: weishi_gz@126.com
      • Contact: Liu Shuangxin, PHD; Phone Number: 62027 8602083827812; Email: mplsxi@yahoo.com
      • Principal Investigator: Shi Wei, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 18 - 70 years old at registration
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:

1. Have peritonitis in recent 3 months other active bacterial infections
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Glycosylated hemoglobin (HbA1c) measurement	24 week follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The frequency of hypoglycemic episodes	Glycemic control, Glycosylated hemoglobin (HbA1c) measurement; Frequency of adverse events; Frequency of clinically significant abnormal laboratory values	at 24 week follow-up

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital
• Investigators: Study Director: Shi Wei, PHD, Guangdong Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: March 9, 2011
• First Submitted That Met QC Criteria: March 28, 2011
• First Posted (Estimate): March 29, 2011

Study Record Updates

• Last Update Posted (Estimate): March 29, 2011
• Last Update Submitted That Met QC Criteria: March 28, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: Continuous glucose monitoring; Insulin pump; CAPD patients
• Other Study ID Numbers: InsulinPump