Clinical trial NCT01324557: Insulin Pump Therapy and Continuous Glucose Monitoring in Diabetic Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Diabetes
Poor Glycemic Control
Keywords: Continuous glucose monitoring
CAPD patients
Insulin pump
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2011-03-29
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Glycosylated hemoglobin (HbA1c) measurement
timeFrame: 24 week follow-up
Secondary outcomes:
measure: The frequency of hypoglycemic episodes
timeFrame: at 24 week follow-up
Other outcomes:
Locations:
city: GuangZhou
country: China
facility: Guangdong General Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Shi Wei, PHD
role: STUDY_DIRECTOR
References: