Sensor-controlled Insulin- and Glucagon Delivery in Subjects With Type 1 Diabetes: Testing of an Automated System in a Supervised Inpatient Setting
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Type I Diabetes Mellitus
- 发起方
- Legacy Health System
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Mean Percent of Time in Target Blood Glucose Range
- 状态
- 已完成
- 最后更新
- 9年前
概览
简要总结
The purpose of this study is to verify an automated system of blood glucose control in Type I Diabetics. The automated system consists of the investigational Artificial Pancreas Control software (APC), two blood glucose sensors, and two hormone pumps, one for delivering insulin to lower blood sugar, and the second for delivering glucagon to raise blood sugar. The blood glucose sensors relays information to the Artificial Pancreas software, which uses the Adaptive Proportional Device algorithm to determine the rate of insulin and glucagon infusion by the hormone pumps. In prior studies, the Adaptive Proportional Device algorithm has been verified, but required manual input into the computer and hormone pumps. This study differs in that it uses a fully automated system under the control of the Artificial Pancreas Control software. The importance of this change is that it is the next step to enable outpatient use of automated, closed loop blood glucose control.
详细描述
The objective of the current human study is to verify the components of the Artificial Pancreas Control system during an inpatient study. This master controller software is designed to be used in conjunction with two subcutaneous continuous glucose monitoring systems to regulate blood glucose levels as well as two Omnipod pumps, one for administering insulin and one for administering glucagon. The sensors communicate wirelessly with two sensor receivers which will be interfaced with the APC by wireless USB connection. The insulin and glucagon pumps will be controlled by the APC through a wireless USB connection. The algorithm included in the APC is an automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm, which was previously studied as an investigational device. The APD has been studied in vivo (in 28 experiments, each 33 hr in length, with manual adjustment of pumps) and no serious adverse effects were noted. Manual input of the glucose sensor data and insulin/glucagon infusion rates will no longer be necessary. The APC will be tested in vivo during 28 hour experiments in an inpatient setting in preparation for outpatient testing.
研究者
W. Kenneth Ward
Senior Scientist
Legacy Health System
入排标准
入选标准
- •Diagnosis of type 1 diabetes mellitus for at least 1 year.
- •Male or female subjects 21 to 65 years of age.
- •Current use of an insulin pump.
- •Willingness to follow all study procedures, including attending all clinic visits.
- •Willingness to sign informed consent and HIPAA documents.
排除标准
- •Pregnancy or Lactation: For women of childbearing potential: there is a requirement for a negative urine pregnancy test and for agreement to use contraception during the study and for at least 1 month after participating in the study. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an IUD, the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence.
- •Renal insufficiency (serum creatinine of 2.0 mg/dL or greater).
- •Serum ALT or AST equal to or greater than 3 times the upper limit of normal; hepatic synthetic insufficiency as defined as a serum albumin of less than 3.3 g/dL; or serum bilirubin of over
- •Adrenal insufficiency
- •Hematocrit of less than or equal to 34%.
- •A history of cerebrovascular disease or coronary artery disease regardless of the time since occurrence.
- •Congestive heart failure, NYHA class III or IV.
- •Diagnosis of 2nd or 3rd degree heart block or any arrhythmia judged by the investigator to be exclusionary.
- •Any active infection.
- •Visual impairment preventing reading of glucose meter values or continuous glucose monitoring device.
结局指标
主要结局
Mean Percent of Time in Target Blood Glucose Range
时间窗: all 28 hour studies
Mean percent of time venous blood glucose was sampled between 70-180 mg/dl
次要结局
- Mean Deviation From Target Blood Glucose(all 28 hour studies)