NCT02773875Unknown不适用
A Randomized Crossover Study to Evaluate the Efficacy of Fault Detection Algorithms Using the ZoneMPC Algorithm and DiAs System in Adult Subjects With Type 1 Diabetes in the Outpatient Setting
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 主要终点
- Amount of time sensor glucose levels are >250 mg/dl
研究概览
简要总结
This is a randomized crossover study testing the efficacy of the Fault Detection algorithms using the Zone MPC algorithm and DiAs artificial pancreas platform in adult patients with type 1 diabetes. The trial will last for 6 weeks for each individual subject, with three weeks using the AP algorithm and three weeks using sensor augmented pump in a randomized order
详细描述
Investigational Device:
Artificial Pancreas System with Fault Detection Algorithms: Roche Accu-Check Spirit Combo Insulin Pump, Dexcom G4P System with Share, Diabetes Assistant (DiAs) on Android phone, DiAs Web Monitoring (DWM)
- referred to as Remote Monitoring Server, MPC control algorithm, Health Monitoring System (HMS) algorithm. Sensor and infusion set fault detection algorithms will be applied offline with data obtained from server and notifications will be sent to the clinician.
Control Arm:
Sensor-augmented insulin pump therapy: Subject will use their personal insulin pump and Dexcom G4P System with Share.
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 55 Years（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 12 months
- •Daily insulin therapy for at least 12 months
- •Age between 18.0 to 55.0 years of age
- •Use of an insulin pump for at least 3 months
- •Subject comprehends English
- •Females of childbearing potential must use an adequate method of contraception and have a negative pregnancy test
- •Total daily insulin requirement ≥ 0.3 units/kg/day
- •Subject has an adult companion, age > 18 years, who lives with the subject, has access to where they sleep, is willing to be in the house when the subject is sleeping and willing to attend to the subject if there are safety concerns -
排除标准
- •Diabetic ketoacidosis in the past 6 months
- •Hypoglycemic seizure or loss of consciousness in the past 6 months
- •Subjects requiring an intermediate or long-acting insulin (such as NPH, detemir or glargine)
- •Subjects using other anti-diabetic medications other than insulin (oral or injectable) at the time of enrollment. Any prior use of other anti-diabetic medications must be washed out for at least 8 weeks prior to enrollment.
- •Current use of other medications, which in the judgment of the investigator would be a contraindication to participation in the study
- •Subject has a medical disorder that in the judgment of the investigator will affect completion of any aspect of the protocol
- •Subject is currently participating in another investigational device or drug study within 30 days or 5-half-lives of the drug.
- •Subject has a history of any cardiac or vascular disorder including, but not limited to, myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, arrhythmia or thromboembolic disease
- •Subject has a history of hepatic disease
- •Subject has renal failure on dialysis
- •Systolic blood pressure > 160 mmHg on screening visit
- •Diastolic blood pressure > 90 mmHg on screening visit
- •Subjects with inadequately treated thyroid disease or celiac disease
- •Subject has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol
- •Subject has received inpatient psychiatric treatment in the past 6 months
- •Subject consumes more than an average of 4 standard alcoholic drinks/day in the last 30 days
- •Subject has an active skin condition that would affect sensor placement
- •Subject is unable to avoid acetaminophen for the duration of the study
- •Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study
- •Subject is currently on beta blocker medication -
结局指标
主要结局
Amount of time sensor glucose levels are >250 mg/dl
时间窗: 4 hours after insulin infusion set failure
Amount of time sensor glucose levels are \>250 mg/dl in the control arm versus the experimental arm
次要结局
- Effectiveness of sensor fault detection algorithm as defined by % of sensor failures caught by the system(During 2 week intervention period)
- Percent of time in range between 70-180 mg/dl(2 week intervention period versus 2 week control period)
- Mean sensor glucose values(2 week intervention period versus 2 week control period)
研究者
B. Wayne Bequette
Professor, Department of Chemical & Biological Engineering Associate Director of Process Technologies
Rensselaer Polytechnic Institute
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