Efficacy and Feasibility of Fully Automated Closed Loop Insulin Pump Therapy After Islet Auto-Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Study Period: Average Serum BG
研究概览
简要总结
The purpose of this study is to determine the effectiveness of closed loop insulin pump therapy to control blood sugar following total pancreatectomy and islet auto-transplantation (TPIAT).
详细描述
OBJECTIVES AND HYPOTHESES The main objective of this study is to determine if a closed loop insulin system can successfully achieve tighter blood sugar control than the current multiple daily injection regimen. The investigators hypothesize that the average blood glucose will be lower in the closed loop group than the control group, there will be less glucose variability in the closed loop group than the control group, and there will be less total time spent in hyperglycemia and hypoglycemia in the closed loop group than in the control group. The investigators also will investigate insulin requirements and islet function in the first 6 months post-transplant in the closed loop group The investigators hypothesize that the insulin requirements will be lower and the C-peptide levels higher in the closed loop group than in the control group.
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
- 21 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing total pancreatectomy and islet auto-transplantation.
- •Patients ages 21 to 64 years old
排除标准
- •Preexisting diabetes
- •Use of acetaminophen during study period, which interferes with CGM sensor function
- •Any medical condition requiring corticosteroids
- •Severe Psychiatric disease or developmental delays, that might interfere with the ability to provide informed consent
- •Any other medical condition which in the opinion of the investigators impairs the person's ability to safely participate in the trial
研究组 & 干预措施
Control
Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
Closed Loop Insulin
Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.
干预措施: Closed Loop Insulin (Device)
结局指标
主要结局
Study Period: Average Serum BG
时间窗: 3 days of investigation period
Mean blood glucose value: a single report of the average of the analytical blood glucose values will be computed and compared between the pump and control groups.
Study Period: Serum BG Standard Deviation
时间窗: 3 days of investigation period
Measure of glycemic variability. This is the standard deviation in all serum BG values for each individual patient.
次要结局
- Day 14 Follow-Up: Average Serum BG(Day 14 Follow-Up)
- Day 14 Follow-Up: C-Peptide(Day 14 Follow-Up:)
- Day 28 Follow-Up: Average Serum BG(Day 28 Follow-Up)
- Day 28 Follow-Up: C-Peptide(Day 28 Follow-Up)
- Study Period: Continuous Glucose Monitor Standard Deviation of BG(continuous over the 72 hour investigation period)
- Study Period: Continuous Glucose Monitor (CGM) BG Average(continuously over the 72 hour investigational period)
- Study Period: % of Time CGM BG <70 mg/dL(continuous over the 72 hour investigation period)
- Study Period: Percent Time BG in Range 70-140 mg/dL(continuous over the 72 hour investigation period)
- Study Period: CGM Area Under the Curve (AUC) With Glucose < 70 mg/dL(continuous over the 72 hour investigation period)
- Study Period: % of Time CGM BG > 140 mg/dL(continuous over the 72 hour investigation period)
- Study Period: CGM AUC With Glucose> 140 mg/dL(continuous over the 72 hour investigation period)
- Study Period: Morning C-peptide(Average of 3 day study period)
- Study Period: Daily Insulin Needs(Average of 3 day study period)