Yale-Harvard Hotel-based Closed-Loop Studies in Children (HY-GRAID)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Hypoglycemia Safety: Number of Participants With Blood Glucose (BG)) Readings < 50 Milligrams/Deciliter (mg/dL))
研究概览
简要总结
The aim of this clinical study is to determine the feasibility, safety, and preliminary effectiveness of the Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP) system in pediatric subjects with type 1 diabetes in an ambulatory semi-supervised environment over a short duration of 3 days and 2 nights, or up to 60 hours.
详细描述
The artificial pancreas platform employed under study is centered about the following four key innovations: 1) A zone model predictive control strategy that is at the same time very safe with respect to hypoglycemia, and can simultaneously and independently be tuned with respect to its response to hyperglycemia; 2) Zone control with diurnal blood-glucose target zones; 3) Models of insulin-glucose physiology and insulin on board; 4) A system for alarming and notification of impending hypoglycemia and technical malfunctions: the Health Monitoring System. These features have been evaluated in several clinical trials in adults with unannounced meals and exercise.
The proposed study will evaluate enhancements to our previous system tailored for the special needs of pediatric subjects: 1) A control strategy with responses to hyperglycemia and hypoglycemia spanning wide ranges, as is typical with children; 2) The use of time-dependent zones specific for pediatric subjects; 3) The development of models for young children, capturing the greater physiologic variability, and ensuring cautious insulin delivery; 4) remote alarming and notification systems that are useful to parents.
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
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 2- <18 years; for first cohort(s), subjects will be 12-17 years; additional age brackets will be 8-11 years and then <8 years
- •Type 1 diabetes for ≥ 1 year duration - the diagnosis of type 1 diabetes will be based on the history of ketosis/ketoacidosis at diagnosis or laboratory evidence of islet-cell auto-immunity
- •A1c level ≤ 10.0%
- •Use of insulin pump and carbohydrate counting for ≥ 3 months
- •Average total daily insulin dose of at least 10 units/day
- •Current or past use of Continuous Glucose Monitoring (CGM) is desirable but NOT required
- •Normal renal function as measured within 6 months of enrollment
- •Normal thyroid function within 6 months of enrollment, or if previously diagnosed with hypothyroidism, documented within 3 months of enrollment
- •Parent/guardian agrees to stay at hotel with subject for duration of hotel phase and has cell phone that can send/receive text messages
- •Subject and participating parent/guardian speak and comprehend English
排除标准
- •Episode of diabetic ketoacidosis (DKA) within 6 months of enrollment
- •Episode of severe hypoglycemia (seizure, loss of consciousness) within 6 months of enrollment
- •Use of medications (other than insulin) known to affect BG levels within 4 weeks of enrollment - examples include systemic glucocorticoids, metformin, pramlintide, liraglutide)
- •Current use of other medications, that in opinion of investigator, would interfere with safety or effectiveness of the study including acetaminophen
- •Medical disorder, that in opinion of investigator, would be contraindication for inclusion; hypothyroidism and celiac disease are NOT exclusion if under good control
- •Female subjects of childbearing potential unwilling to have pregnancy testing
- •Female subject currently pregnant or lactating
- •History of alcohol or drug abuse, documented eating disorder, or inpatient psychiatric treatment within 6 months of enrollment
- •Subject is currently participating in another research study involving an investigational drug or device
结局指标
主要结局
Hypoglycemia Safety: Number of Participants With Blood Glucose (BG)) Readings < 50 Milligrams/Deciliter (mg/dL))
时间窗: 60 hours
Number of participants with more than one confirmed BG \< 50 mg/dL
Hyperglycemia Safety: Number of Participants With More Than Two Blood Glucose (BG) Readings > 300 mg/dL Longer Than 2 Hour or Any BG 400 > Milligrams/Deciliter (mg/dL))
时间窗: 60 hours
No more than two confirmed BG ≥ 300 mg/dL longer than 2 hours, and no BG ≥ 400 mg/dL, unless determined to be from an infusion site failure.
Blood Ketone Safety: Number of Participants With Blood Ketone Levels > 1.0 mmol/l for Longer Than 2 Hours or Any Ketone Level> 3.0 mmol/l
时间窗: 60 hours
Number of participants with blood ketone level \> 1.0 mmol/l for longer than 2 hours, and no blood ketone level \>3.0 mmol/L, unless determined to be from an infusion site. failure
Safety: Number of Participants Who Experienced an Adverse Event
时间窗: 60 hours
Adverse events include seizure, loss of consciousness, severe hypoglycemia, diabetic ketoacidosis
次要结局
- Mean Meter and Sensor Glucose Levels Milligram/Deciliter (mg/dL)(60 hours)
- Percent Sensor Glucose Time in Range (70-180 mg/dL)(60 hours)
- Percent Sensor Glucose Time Below Range (<70 mg/dL)(60 hours)
- Percent Sensor Glucose Time Above Range (>180 mg/dL)(60 hours)
- Percent Sensor Glucose Time in Hypoglycemia (<60 mg/dL)(60 hours)
- Percent Sensor Glucose Time in Hyperglycemia (>250 mg/dL)(60 hours)
- Percent Time AP System Active(60 hours)