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临床试验/NCT00574405
NCT00574405已完成不适用

Preservation of Pancreatic Beta Cell Function Through Insulin Pump Therapy

Arkansas Children's Hospital Research Institute1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2005年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
Change in Mixed-meal-stimulated Peak C-peptide Value (Via Mixed-meal Tolerance Test) After 12 Months of Insulin Pump Therapy, Compared With MDI.

研究概览

简要总结

Type I diabetes (T1DM) is the second most common chronic illness effecting children in the USA. Worldwide, Type I diabetes is increasing in incidence, and its underlying etiology remains elusive. Nevertheless, recent data supports the notion that early and intensive management of Type I diabetes can 1) decrease long-term complications of diabetes; and 2) may significantly improve beta cell function and insulin secretion over ensuing years. To this end, we propose using insulin pump therapy to preserve and/or enhance residual endogenous B-cell secretory capacity among patients with newly diagnosed Type 1 DM. Furthermore, we anticipate that early use of an insulin pump will improve glycemic control beyond that achieved with standard multiple daily injection (MDI) therapy, and will be well-tolerated by the patient. These data will provide important pilot information to explore the potential role of intensive insulin pump therapy in the treatment of children newly diagnosed with Type I diabetes. The specific aim of this study is to test the following hypothesis: Early use of insulin pump therapy is effective in preserving or enhancing residual endogenous pancreatic B-cell secretory capacity among patients with newly diagnosed T1DM: Moreover, early use of an insulin pump will improve glycemic control beyond that achieved with standard multiple injection therapy, and will be well-tolerated by the patient.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Medical history and clinical presentation consistent with the diagnosis of Type 1 DM.
  • Age: 8-18 years

排除标准

  • Clinical presentation consistent with Type 2 DM.
  • History of other chronic systemic inflammatory or autoimmune disease or other severe medical conditions.
  • Concurrent pregnancy.
  • Participation in other research protocols or use of other investigational agents within 30 days of enrollment.

研究组 & 干预措施

2

Experimental

CSII (insulin pump), using Animas Corporation insulin pump, model IR 1200.

干预措施: CSII (Animas Corporation insulin pump, model IR 1200) (Device)

1

Active Comparator

MDI = 3-4+ insulin injections/day, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®).

干预措施: MDI (split-mix NPH insulin + regular insulin or Lantus + Novolog® [or Humalog®]) (Drug)

结局指标

主要结局

Change in Mixed-meal-stimulated Peak C-peptide Value (Via Mixed-meal Tolerance Test) After 12 Months of Insulin Pump Therapy, Compared With MDI.

时间窗: 12 months

次要结局

  • Changes in Glycemic Control, as Assessed by the Change in Hemoglobin A1c and Variations in Daily Blood Glucose Measurements (Fasting BG and CGMS) From Day 1 of Treatment to Month 12 of Treatment.(12 months)
  • Changes in Daily Insulin Requirements Over Time(12 months)
  • Frequency of Adverse Glycemic Consequences, i.e., Frequency of Hypoglycemia, Severe Hyperglycemia or Ketosis.(12 months)
  • Patient Satisfaction With Mode of Therapy and Patient Compliance With Treatment Recommendations.(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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