Inpatient Evaluation of the MD-Logic Artificial Pancreas System in Patients
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Overall frequency of hypoglycemia
研究概览
简要总结
The purpose of this feasibility study is to evaluate the MDLAP (MD-Logic Artificial Pancreas system)automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes. The study will include 3 inpatient admissions (12-24 hr), which will include overnight sleep, over-bolus meal, under-bolus meal and exercise.
详细描述
The purpose of this feasibility study is to evaluate the MDLAP (MD-Logic artificial pancreas system)automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes. The study will include 3 inpatient admissions (12-24 hr), which will include overnight sleep, over-bolus meal, under-bolus meal and exercise. During the the visits, meal boluses will be semi-automated, with manual meal announcement by the physician/nurse, automated bolus recommendation by the system, and automated delivery of the bolus following confirmation of the recommendation. Between-meal insulin dosing will be fully automated. Bolus confirmation by the physician/nurse will be requested by the closed loop controller only when it determines that carbohydrates may be necessary to avoid hypoglycemia following the bolus.
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
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of type 1 diabetes for at least one year and using an insulin pump for at least 6 months
- •Age 12 to 65 years
- •Hemoglobin A1c (HbA1c) between 5.0% and 10.5%, as measured with DCA2000 or equivalent device
- •For females, not currently known to be pregnant
- •Demonstration of proper mental status and cognition for the study
- •An understanding of and willingness to follow the protocol and sign the informed consent or assent
排除标准
- •Diabetic ketoacidosis in the past 6 months
- •Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
- •History of a seizure disorder (except hypoglycemic seizure).
- •Coronary artery disease or heart failure.
- •Cystic fibrosis
- •Active infection
- •A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol
- •A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the exercise protocol
- •Current use of a beta blocker medication
- •Hematocrit <30%
- •Use of pseudoephedrine 48 hours prior to Clinical Research Center (CRC) admission
结局指标
主要结局
Overall frequency of hypoglycemia
时间窗: day 3
Success defined as no subjects with severe hypoglycemia with a low blood glucose resulting in seizure, unconsciousness or the inability to treat oneself.
Overall frequency of hyperglycemia
时间窗: Day 3
Success defined as no subjects with diabetic ketoacidosis (DKA).
Percent of glucose values 71-180 mg/dL of combined day and night readings during the first admission visit
时间窗: Day 1
Percent of subjects with blood glucose reading of 71-180 mg/dL 4 hours following the breakfast with a missed meal bolus
时间窗: Day 1
Success is defined as \>=40% subjects with a blood glucose in the 71-180 mg/dL range.
Percent of subjects with blood glucose reading of 71-180 mg/dL 5 hours following the breakfast with a meal bolus 30% more than the recommended bolus amount
时间窗: Day 2
Success is defined as \>=50% subjects with a blood glucose in the 71-180 mg/dL range.
Percent of subjects with a blood glucose nadir <=60 mg/dL following exercise
时间窗: Day 3
Success is defined as less than 25% of subjects with a blood glucose nadir \<=60 mg/dL.
Percent of subjects with a peak blood glucose >400 mg/dL following the breakfast with a meal bolus 30% more than the recommended bolus amount
时间窗: day 2
Success is defined as less than 5% of subjects have a peak blood glucose \>400 mg/dL
次要结局
- Percent of blood glucose values >400 mg/dL during the first admission visit(Day 1)
- Percent of blood glucose values <=60 mg/dL during the first admission visit(Day 1)
- Percent of subjects with a peak blood glucose >400 mg/dL following the breakfast with a missed meal bolus(Day 1)
- Percent of subjects with a nadir blood glucose <=60 mg/dL following the breakfast with a missed meal bolus(Day 1)
- Percent of blood glucose values 71-180 mg/dL during the day (9:00AM-11:00PM) of the first admission visit(Day 1)
- Percent of blood glucose values 70-180 mg/dL during the night (11:00PM-8:00AM) of the first admission visit(Day 1)
- Percent of subjects with a nadir blood glucose <=60 mg/dL following the breakfast with a meal bolus 30% more than the recommended bolus amount(Day 2)