In home closed loop reduction of nocturnal hypoglycemia and daytime hyperglycemia

描述(申请人提供)：1型糖尿病(T1D)患者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。后者通常发生在继发于误餐和零食胰岛素丸的青少年中。这两个问题都将在这笔赠款的五年内得到解决。由于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预测和预防夜间低血糖，使用闭环系统(CLS)，其中来自连续血糖监测仪(CGM)的信息被用于暂停胰岛素泵的胰岛素输送。初步研究将在临床转化研究中心(CTRC)进行，以证明“Florence”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，完全便携式的CLS将被用来检测和纠正因错过进食丸剂而导致的高血糖。利用来自CGM的信号并向胰岛素泵提供输出的算法的安全性和有效性将在CTRC的赠款的第三年进行初步研究。在这笔赠款的第4年和第5年，我们计划评估雅培糖尿病护理公司开发的完全非卧床系统中预防低血糖和高血糖的联合算法。我们认为，预防低血糖，特别是夜间低血糖，以及减少餐后高血糖将导致血糖控制的改善和糖化血红蛋白水平的降低。 公共卫生相关性：低血糖是1型糖尿病患者达到最佳血糖控制的主要威慑因素之一。这项研究的重点是降低1型糖尿病患者的低血糖和餐后高血糖。希望这将改善参与者的血糖控制。

DESCRIPTION (provided by applicant): 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. PUBLIC HEALTH RELEVANCE: Hypoglycemia is one of the main deterrents for attaining optimal glycemic control for people with type 1 diabetes. This research is focused on reducing hypoglycemia as well as hyperglycemia after meals in people with type 1 diabetes. Hopefully this will lead to improved glycemic control for participants.