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临床试验/NCT01324557
NCT01324557Unknown2 期

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

Guangdong Provincial People's Hospital1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2011年3月最近更新:
适应症
干预措施

试验速览

阶段
2 期
入组人数
44
试验地点
1
主要终点
Glycosylated hemoglobin (HbA1c) measurement

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 - 70 years old at registration
  • Type 1 or Type 2 Diabetic CAPD patients for at least 3 month and less than 60 months
  • Hemoglobin A1c of at least 7.5% at registration Kt/V is greater than 1.7

排除标准

  • Have peritonitis in recent 3 months other active bacterial infections
  • Unstable clinical conditions or evidence of malignancy
  • Non-diabetic ESRD patients
  • Individuals already receiving diabetes therapy via an insulin pump

研究组 & 干预措施

CSII

Experimental

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

干预措施: CSII and MDI (Procedure)

MDI

No Intervention

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

干预措施: CSII and MDI (Procedure)

结局指标

主要结局

Glycosylated hemoglobin (HbA1c) measurement

时间窗: 24 week follow-up

次要结局

  • The frequency of hypoglycemic episodes(at 24 week follow-up)

研究者

申办方类型
Other

研究点 (1)

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