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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01324557
Other study ID # InsulinPump
Secondary ID
Status Recruiting
Phase Phase 2
First received March 9, 2011
Last updated March 28, 2011
Start date March 2011
Est. completion date December 2013

Study information

Verified date March 2011
Source Guangdong General Hospital
Contact Shi Wei, PHD
Phone 8602083827812
Email weishi_gz@126.com
Is FDA regulated No
Health authority China: Guangdong General Hospital Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 44
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
CSII and MDI
The aims of this study are to assess the potential efficacy and safety of insulin pump(MiniMed Paradigm® REAL-Time Revelâ„¢ Insulin Pump) to improve glycemic control in conjunction with continuous glucose monitoring (CGMS) for diabetic CAPD Patients.

Locations

Country Name City State
China Guangdong General Hospital GuangZhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Guangdong General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Glycosylated hemoglobin (HbA1c) measurement 24 week follow-up Yes
Secondary 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 Yes
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