Subcutaneous Continuous Glucose Monitoring and Intravenous Dosing of Insulin and Dextrose for Automated Glycemic Control in the Inpatient Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Average Blood Glucose Over the Closed-loop Control Period, as Determined From GlucoScout Measurements.
研究概览
简要总结
The purpose of this study is to test an experimental medical device designed to automatically control blood sugar. This device was designed for use by patients with diabetes while they are in the hospital, and others who may develop high blood sugar as a result of their medical problems.
详细描述
The goal of this first-in-man trial is to test the safety and efficacy of the automated, closed-loop control system in insulin sensitive subjects with type 1 diabetes, insulin sensitive subjects with type 2 diabetes (TTD > 1u/kg/day), and subjects with type 2 diabetes and substantial insulin resistance (<2 u/kg/day). The results of this study will help to design future studies, exploring the use of the closed-loop system for BG control in hospitalized patients, including those with diabetes or hyperglycemia of critical illness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Pregnancy
- •Renal insufficiency
- •Abnormal EKG suggestive of coronary artery disease or increased risk of malignant arrhythmia
- •Acute illness or exacerbation of chronic illness at the time of the study procedure
- •Use of non-insulin, injectable anti-diabetic medications or oral anti-diabetic medications other than metformin
- •History of allergy or adverse reaction to aspirin, peptic ulcers or bleeding disorders
- •Known history of coronary artery disease, TIA or stroke
- •History of seizures
- •Transaminitis
- •Stage 2 hypertension at the time of screening
研究组 & 干预措施
Closed-loop blood glucose control
Type 1 diabetes, Type 2 diabetes, total daily dose (TDD) of insulin that is > 1 u/kg or > 2 u/kg.
干预措施: Closed-loop blood glucose control (Device)
结局指标
主要结局
Average Blood Glucose Over the Closed-loop Control Period, as Determined From GlucoScout Measurements.
时间窗: 12 hours
次要结局
- Number of Carbohydrate Interventions (15 g) Delivered According to Study Protocol(12 hours)
- Number of BG Events < 70 mg/dl and Nadir BG for Each as Determined Form GlucoScout Measurements(12 hours)
- Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From GlucoScout Measurements: - < 70 mg/dl - 70-120 mg/dl - 70-180 mg/dl - >180 mg/dl(12 hours)
- Average Blood Glucose Over the Closed-loop Control Period as Determined From the CGM Driving the Control Algorithm(12 hours)
- Number of BG Events < 70 mg/dl as Determined by the CGM(12 hours)
- Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From the CGM Driving the Control Algorithm: o < 70 mg/dl o 70-120 mg/dl o 70-180 mg/dl o >180 mg/dl(12 hours)
- Insulin Dosing (u/kg)(12 hours)
- Dextrose Dosing (g/kg)(12 hours)
- Accuracy of the CGM Device Using the GlucoScout Measurements as the Standard.(12 hours)
研究者
Steven J. Russell, MD, PhD
Assistant Professor of Medicine
Massachusetts General Hospital