Diabetes, Poor Glycemic Control
Conditions
Keywords
Continuous glucose monitoring, CAPD patients, Insulin pump
Brief 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.
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.
Interventions
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.
Sponsors
Study design
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycosylated hemoglobin (HbA1c) measurement | 24 week follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The frequency of hypoglycemic episodes | at 24 week follow-up | Glycemic control, Glycosylated hemoglobin (HbA1c) measurement; Frequency of adverse events; Frequency of clinically significant abnormal laboratory values |
Countries
China