Randomized Crossover Feasibility Study of Artificial Pancreas Device (AP) Using Zone-MPC Controller (Zone-Model Predictive Control) and Health Monitoring System (HMS) With and Without Basal and Insulin-to-Carbohydrate Bolus Initialization
概览
- 阶段
- 早期 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Type 1 Diabetes Mellitus
- 发起方
- Sansum Diabetes Research Institute
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- time spent in safe blood glucose range
- 状态
- 已完成
- 最后更新
- 10年前
概览
简要总结
The purpose of this trial is to assess the performance of an Artificial Pancreas (AP) device using the Portable Artificial Pancreas System (pAPS) platform for subjects with type 1 diabetes using an insulin pump and rapid acting insulin. This proposed study is designed to compare closed-loop control with or without optimization of initialization parameters related to basal insulin infusion rates and insulin to carbohydrate (I:C) ratios for meals and snacks.
详细描述
The study consists of an evaluation of the Artificial Pancreas device system during two 24-27.5-hour closed-loop phases in an outpatient/hotel environment. Prior to the closed-loop phases, each subject will undergo a 7-day data collection period consisting of his or her usual free-living conditions along with 3 meals of known carbohydrate content. Data from the insulin pump, a continuous glucose monitoring sensor (CGM), diet and exercise records will be collected during this period. These data from this 7-day period will be analyzed in order to come up with adapted basal insulin infusion rates and bolus insulin to carbohydrate (I:C) ratios.
研究者
入排标准
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 with commercially available rapid acting insulin
- •The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
- •Age 21 to 65 years
- •For females, not currently known to be pregnant or nursing
- •HbA1c ≤ to 10%, as measured with DCA2000 or equivalent device
- •Willing to perform the calibration of the study CGMs using a finger stick only and willing to follow instructions for insulin pump and CGM wear.
- •Willing to use the study CGM and study insulin pump during closed-loop.
- •Able to and agrees to avoid the following medication starting 24 hours before sensor wear through completion of the close loop study visit: acetaminophen, prednisone, and pseudoephedrine.
- •An understanding of and willingness to follow the protocol and sign the informed consent.
排除标准
- •Pregnancy (as determined by a positive blood pregnancy test performed in females of childbearing capacity during screening visit and urine test at time of admission for in-patient visit) or nursing mother.
- •Females who are sexually active and able to conceive that do not use contraception.
- •Any documented arrhythmias.
- •Diabetic ketoacidosis in the past 6 months prior to enrollment requiring emergency room visit or hospitalization
- •Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
- •Current treatment for a seizure disorder; Subjects with a history of seizures may be included in the study if they receive written clearance from their neurologist
- •Active infection
- •A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as cognitive deficit.
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation, including subjects not able to read or write.
- •Coronary artery disease or heart failure. Subjects with a history of coronary artery disease may be included in the study if they receive written clearance from their cardiologist
结局指标
主要结局
time spent in safe blood glucose range
时间窗: 24-hour closed-loop
The percentage time spent in safe blood glucose range of \[80-140\] mg/dl will be the primary endpoint. More time spent inside the desired range will be considered successful. Expected levels are \[70-180\] mg/dl the 5 hours after meals and \[70-150\] mg/dl 3 hours after exercise.
次要结局
- glucose level extremes and need for outside intervention(24-hour closed loop)