Evaluation of a Novel Method for Integrating Insulin Delivery and Glucose Sensing in Subcutaneous Tissue for the Treatment of Type-1 Diabetic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Ratio between the plasma glucose level and the glucose concentration at the subcutaneous insulin delivery site
研究概览
简要总结
The study seeks to use microdialysis and microperfusion techniques to assess the feasibility of combining insulin delivery and glucose sensing at a single subcutaneous tissue site.
详细描述
Current treatment of in type 1 diabetes comprises the measurement of glucose in capillary blood obtained by fingersticking and administration of exogenous insulin in the form of a subcutaneous bolus injection or subcutaneous infusion. This treatment could be simplified if there were a stable ratio between blood glucose concentration and tissue glucose level at the site of insulin delivery so that tissue glucose levels could be used to estimate blood glucose levels, thereby circumventing the need for fingerstick blood glucose monitoring.
The aim of this study is to ascertain whether a stable ratio between the blood glucose concentration and the glucose levels at the tissue site of insulin infusion exists when this tissue site is exposed to variable insulin infusion rates. To achieve this, microdialysis and microperfusion probes are applied in healthy and type 1 diabetic subjects to perform insulin delivery and glucose sampling at the same adipose tissue site during euglycemic clamps and oral glucose tolerance tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Type 1 diabetes mellitus patients aged 18 - 65
- •Healthy subjects aged 18 - 65
- •Informed consent obtained before any trial-related activities.
- •Diabetic subjects:
- •C-peptide negative (≤ 0.05 nmol/L)
- •HbA1c (glycosylated haemoglobin A1c) < 10%
排除标准
- •Severe diabetic complications (e.g., proliferative retinopathy, severe nephropathy)
- •Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods
- •Subject with mental incapacity or language barriers
结局指标
主要结局
Ratio between the plasma glucose level and the glucose concentration at the subcutaneous insulin delivery site
时间窗: 1 day
次要结局
未报告次要终点
研究者
Stefan Korsatko, MD
MD
Medical University of Graz