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

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status and phase: Unknown; Phase 2

Conditions: Poor Glycemic Control; Diabetes

Treatments: Procedure: CSII and MDI

Study type: Interventional

Funder types: Other

Identifiers

NCT01324557

InsulinPump

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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44 participants in 2 patient groups

CSII

Experimental group

Description:

Optimized subcutaneous insulin infusion by means of continuous subcutaneous insulin infusion (CSII)

Treatment:

Procedure: CSII and MDI

MDI

No Intervention group

Description:

MDI: Control Optimized subcutaneous insulin by multiple daily injections (MDI)

Treatment:

Procedure: CSII and MDI