Continuous Glucose Sensing at the Site of Subcutaneous Insulin Administration: Evaluation of a Novel Single-Port Treatment Approach in Type 1 Diabetic Patients During a 1-Day Stay in a Clinical Research Center and a 6-Day Period at Home
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Mean absolute relative difference between sensor readings and capillary glucose readings
研究概览
简要总结
The study seeks to evaluate a novel treatment approach for performing continuous real-time glucose sensing and insulin delivery at the same subcutaneous tissue site.
详细描述
The treatment of type 1 diabetes usually comprises the measurement of glucose in blood obtained by finger pricking and the administration of insulin via subcutaneous bolus injection or continuous subcutaneous infusion.
This study seeks to test a new treatment approach where glucose sensing and insulin administration are combined and performed at a single subcutaneous tissue site (single-port treatment approach). A single-port device consisting of a continuous glucose sensor and an insulin infusion cannula is inserted into the subcutaneous tissue of 10 type-1 diabetes patients and used for insulin infusion and simultaneous glucose sensing over a 7-day period. The performance of the single-port device is assessed by comparing the obtained glucose readings with those of a blood glucose meter and an additionally worn control sensor.
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
- 否
入选标准
- •18 to 65 years of age, both inclusive
- •Type 1 diabetes treated with Continuous Subcutaneous Insulin Infusion (CSII)
- •HbA1C < 10%
- •Signed informed consent before any study-related activities
排除标准
- •Severe acute diseases
- •Clinically overt diabetic complications
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
- •Taking of any vasoactive substances or anticoagulation medication
- •Diseases of the skin which could interfere with application of the catheters and Sensors as judged by the investigator
- •Pregnancy, breastfeeding, intention of becoming pregnant or not using adequate contraception.
- •Increased tendency towards development of hypoglycaemia
- •Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject
- •Concurrent participation in another study
研究组 & 干预措施
glucose sensing and insulin delivery
Subcutaneous insulin delivery with an insulin pump plus glucose sensing with a continuous glucose sensor placed at the site of subcutaneous insulin delivery.
In parallel, capillary glucose determinations using a conventional glucose meter as well as glucose sensing in subcutaneous, insulin-unexposed tissue using a continuous glucose sensor.
干预措施: insulin delivery (Drug)
glucose sensing and insulin delivery
Subcutaneous insulin delivery with an insulin pump plus glucose sensing with a continuous glucose sensor placed at the site of subcutaneous insulin delivery.
In parallel, capillary glucose determinations using a conventional glucose meter as well as glucose sensing in subcutaneous, insulin-unexposed tissue using a continuous glucose sensor.
干预措施: glucose sensing (Device)
结局指标
主要结局
Mean absolute relative difference between sensor readings and capillary glucose readings
时间窗: 7 days
Mean absolute relative differences calculated by determining the mean of the absolute value of the percentage difference between paired sensor and capillary glucose concentration
次要结局
未报告次要终点
研究者
Pieber Thomas, MD
MD, Prof. of Medicine
Medical University of Graz