Use of a Real Time Continuous Glucose Monitoring System (RT-CGMS) in Type 1 Diabetes Patients on Continuous Intraperitoneal Insulin Infusion (CIPII. A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Clinical effectiveness: percentage of time spent in euglycaemia
研究概览
简要总结
To investigate the effectiveness and safety of a Real Time Continuous Glucose Monitoring System (RT-CGMS in a population of patients with type 1 diabetes mellitus treated with insulin through an implanted pump.
详细描述
Background: Strict glycaemic control reduces risk of complications and improves quality of life in patients with type 1 diabetes mellitus. Real Time Continuous Glucose Monitoring System (RT-CGMS) is a novel system which can provide patients and health care professionals with real time information about the blood glucose level without the need for multiple invasive measurements. Furthermore, with continuous monitoring it is possible to identify trends in glycaemic profiles. Its effectiveness and safety have never been tested in a population of patients with type 1 diabetes mellitus treated with insulin through an implanted pump.
Objective
To investigate the effectiveness and safety of the RT-CGMS in patients treated with intraperitoneal continuous insulin infusion (CIPII).
Study design: Open label, randomized cross-over, single-center controlled trial.
Study population: Patients on CIPII. Intervention: There are 3 study phases. In the Baseline phase, all patients will have the RT-CGMS blinded so that no information on blood glucose values measured and stored by the RT-CGMS will be available to care-givers, investigators or patients during this study period. Randomization will determine the sequence of blinded and unblinded RT-CGMS in the 2nd and 3rd phase. When the RT-CGMS is not blinded, the system will alert whenever a glucose level falls below or rises above preset values. Sensor values are not intended to be used directly for making therapy adjustments. Whenever a value is below or above the preset value, the blood glucose level will be measured using a blood glucose meter and therapy adjustments based on this value will be done according to protocol.
Study endpoints: Primary: Percentage of time spent in euglycaemia. Secondary: percentage of time spent in hypoglycaemia and hyperglycaemia, incidence and severity of hypoglycaemia (as measured with SMBG), incidence of adverse effects, number of measurements of blood glucose (SMBG) performed, number of adjustments of insulin therapy, patient satisfaction, agreement of paired SMBG and RT-CGMS measurements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients on CIPII and treated in the Isala Clinics, Zwolle, The Netherlands
- •Age >18 years
- •Uncontrolled diabetes mellitus type 1
排除标准
- •Failure to obtain informed consent
- •Any condition prevention proper handling of the device, for instance hearing impairment or visual impairment
- •Known allergy to sensor (parts)
- •Currently pregnant or trying to conceive
结局指标
主要结局
Clinical effectiveness: percentage of time spent in euglycaemia
时间窗: 3-6 days
次要结局
- Clinical effectiveness: Percentage of time spent in hypoglycaemia and hyperglycaemia.(3-6 days)
- Safety: incidence of adverse effects(ca. 30 days)
- Incidence of hypoglycaemia; Number of SMBG performed, Number of adjustments of insulin therapy, Patient satisfaction, agreement of paired SMBG and RT-CGMS measurements.(3-6 -30 days)