Perioperative Closed-loop Insulin Delivery Versus Standard Insulin Therapy - a Randomised Controlled Parallel Clinical Trial in Adults With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- The proportion of time spent in the target glucose range from 5.6 to 10.0 mmol/L based on sensor glucose levels during the time from hospital admission for elective surgery until discharge.
研究概览
简要总结
The prevalence of diabetes and hyperglycaemia in surgical patients is rising and associated with grater complication rates, length of stay and mortality rates. Suboptimal glucose management in the perioperative setting remains a major barrier to optimal surgical care. While there are guidelines to manage perioperative diabetes care, implementation is challenging and inconsistent, in part due to a stretched workforce, involvement of several disciplines and clinical teams and shortcomings in clinical training and knowledge. Closed-loop glucose control represents an emerging diabetes treatment modality that autonomously adjusts insulin delivery according to continuously measured glucose levels. The use of fully automated closed-loop insulin delivery may represent an easy-to-adopt approach for safe and effective perioperative diabetes management.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •The subject is aged 18 years or over
- •Diagnosis of type 2 diabetes using standard diagnostic practice (37)
- •The subject is planned for an elective abdominal, thoracic or cardiovascular surgery at the University Hospital Bern expected to last ≥2 hours
- •The subject requires treatment with subcutaneous insulin as part of the perioperative glucose management
- •The subject is literate in German
- •The subject is willing to wear study devices 24/7
排除标准
- •Physical or psychological condition likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator
- •Known or suspected allergy to insulin
- •Type 1 diabetes
- •Pregnancy, planned pregnancy, or breast feeding
- •Medically documented allergy towards the adhesive (glue) of plasters or unable tolerate tape adhesive in the area of sensor placement
- •Lack of safe contraception for female participants of childbearing potential for the entire study duration (medically reliable method of contraception are considered oral, injectable, or implantable contraceptives, intrauterine contraceptive devices, or any other methods judged as sufficiently reliable by the investigator in individual cases).
- •Serious skin diseases located at places of the body, which potentially are possible to be used for localisation of the glucose sensor
- •Illicit drug abuse or prescription drug abuse
- •Incapacity to give informed consent
- •Droplet/airborne isolation precautions
- •Participation in another clinical trial that interferes with the interpretation of the study results
研究组 & 干预措施
Closed-loop insulin therapy
干预措施: CamAPS (Device)
Standard insulin therapy
干预措施: Standard insulin therapy (Drug)
结局指标
主要结局
The proportion of time spent in the target glucose range from 5.6 to 10.0 mmol/L based on sensor glucose levels during the time from hospital admission for elective surgery until discharge.
时间窗: Up to 20 days
次要结局
- Proportion of time spent with sensor glucose values above target (> 10.0 mmol/L)(Up to 20 days)
- Proportion of time spent with sensor glucose <3.0 mmol/L(Up to 20 days)
- Total daily insulin requirements(Up to 20 days)
- Average of sensor glucose level(Up to 20 days)
- Time spent with sensor glucose below target (5.6 mmol/L)(Up to 20 days)
- Proportion of time spent with sensor glucose levels in significant hyperglycaemia (glucose levels > 20 mmol/L)(Up to 20 days)
- Standard deviation and coefficient of variation of sensor glucose levels(Up to 20 days)