In home closed loop reduction of nocturnal hypoglycemia and daytime hyperglycemia

摘要 在1型糖尿病(T1D)患者中达到正常血糖的两个主要问题是 低血糖(包括对严重低血糖的恐惧)和餐后高血糖。后者 通常发生在青少年中，继发于错过进餐和零食胰岛素丸。两个都是 这些问题将在这笔赠款的五年内得到解决。超过一半的严重 低血糖事件发生在睡眠中，我们将继续开发算法来 使用闭环系统(CLS)预测和预防夜间低血糖 来自连续血糖监测仪(CGM)的信息被用于通过以下方式暂停胰岛素的输送 胰岛素泵。初步研究将在临床转化研究中心进行 (CTRC)来记录“佛罗伦萨”CLS(雅培糖尿病护理)的安全性，然后我们将 在拨款的第二年和第三年在家庭环境中进行随机临床试验。 同样，将使用完全便携式的CLS来检测和纠正由以下原因引起的高血糖 错过了进食。利用CGM信号的算法的安全性和有效性 并向胰岛素泵提供输出，最初将在CTRC的第三年进行研究 格兰特。在这笔赠款的第四年和第五年，我们计划评估预防的联合算法 雅培糖尿病公司开发的完全非卧床系统中的低血糖和高血糖 关心。我们认为，预防低血糖，特别是夜间低血糖，减少后遗症 膳食高血糖可改善血糖控制，降低HbA1c 级别。

ABSTRACT Two of the major problems in attaining euglycemia in subjects with type 1 diabetes (T1D) are hypoglycemia (including fear of severe hypoglycemia) and post-meal hyperglycemia. The latter commonly occurs in adolescents secondary to missed meal and snack insulin boluses. Both of these issues will be addressed over the five years of this grant. As over half of severe hypoglycemic events occur during sleep, we will continue our development of algorithms to predict and prevent nocturnal hypoglycemia using a closed loop system (CLS) in which the information from a continuous glucose monitor (CGM) is used to suspend delivery of insulin by an insulin pump. Initial studies will be done in the Clinical Translational Research Centers (CTRCs) to document safety of the "Florence" CLS (Abbott Diabetes Care) and we will then conduct a randomized clinical trial in the home environment in years 2 and 3 of the grant. Similarly, a fully portable CLS will be used to detect and correct hyperglycemia resulting from missed food boluses. The safety and efficacy of algorithms which utilize the signal form a CGM and provide output to an insulin pump will initially be studied in the CTRC's in year 3 of the grant. In years 4 and 5 of this grant we plan to assess the combined algorithms for prevention of hypoglycemia and hyperglycemia in a fully ambulatory system developed by Abbott Diabetes Care. We believe that prevention of hypoglycemia, particularly at night, and reduction of post prandial hyperglycemia will result in improvement in glycemic control and reduction in HbA1c levels.