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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Guangdong General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Guangdong General Hospital
ClinicalTrials.gov Identifier:
NCT01324557
First received: March 9, 2011
Last updated: March 28, 2011
Last verified: March 2011
  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

Resource links provided by NLM:


Further study details as provided by Guangdong General Hospital:

Primary Outcome Measures:
  • Glycosylated hemoglobin (HbA1c) measurement [ Time Frame: 24 week follow-up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01324557

Contacts
Contact: Shi Wei, PHD 8602083827812 ext 62027 weishi_gz@126.com
Contact: Liu Shuangxin, PHD 86020837812 ext 62027 mplsxi@yahoo.com.cn

Locations
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         
Sponsors and Collaborators
Guangdong General Hospital
Investigators
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
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014