DEVELOPMENT OF ALGORITHMS FOR A PROTOTYPE CLOSED LOOP INSULIN PUMP

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 雅培糖尿病护理公司开发的导航仪可帮助进行实时连续血糖监测(CGM)。我们认为，开发闭环系统的第一步将是CGM和连续皮下胰岛素输注(CSII)泵之间的通信，当CGM检测到低血糖且受试者对低血糖警报没有反应时，暂停基础胰岛素的输送。暂停基础胰岛素供应可能为解决严重的夜间低血糖问题提供一种解决方案。这项试验将开始评估CGM作为一种预防严重夜间低血糖的方法。 在启动测试这些能力的研究之前，将在临床研究中心(CRC)为严重低血糖风险较低的受试者开发用于原型闭环系统的算法。这些算法将在后续研究中整合到Navigator CGM中，以确定关闭CSII的最佳葡萄糖变化率。我们的目标是证明这将减少血糖水平低于70 mg/dl和低于50 mg/dl的时间，并可能防止严重的低血糖。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The Navigator by Abbott Diabetes Care has been developed to assist in real-time continuous glucose monitoring (CGM). We believe that the first step toward development of the closed loop system will be communication between a CGM and the continuous subcutaneous insulin infusion (CSII) pump to suspend delivery of basal insulin when the CGM detects hypoglycemia and the subject has failed to respond to a hypoglycemic alarm. The suspension of basal insulin delivery may provide a solution to the problem of severe nocturnal hypoglycemia. This trial will begin to evaluate the use of a CGM as a method to prevent severe nocturnal hypoglycemia. Before initiating a study to test these capabilities, algorithms to be used in the prototype closed loop system will be developed in the Clinical Research Center (CRC) in subjects at low risk for severe hypoglycemia. These algorithms will be integrated into the Navigator CGM in follow-up studies to determine what glucose-rate-of-change is optimal for turning off the CSII. We aim to show that this will decrease the time spent with glucose levels below 70 mg/dl, as well as below 50 mg/dl and possibly prevent severe hypoglycemia.