Preservation of Pancreatic Beta Cell Function Through Insulin Pump Therapy
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
- 否
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
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
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)
