In home closed loop reduction of nocturnal hypoglycemia and daytime hyperglycemia

描述（由申请人提供）：1型糖尿病（T1D）受试者在获得血糖正常方面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，继发于缺餐和零食胰岛素推注。这两个问题将在该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期间，我们将继续开发使用闭环系统（CLS）预测和预防夜间低血糖的算法，其中来自连续葡萄糖监测仪（CGM）的信息用于暂停胰岛素泵的胰岛素输注。初步研究将在临床转化研究中心（CTRC）进行，以记录“佛罗伦萨”CLS（雅培糖尿病护理）的安全性，然后我们将在赠款的第2年和第3年在家庭环境中进行随机临床试验。类似地，完全便携式CLS将用于检测和纠正由于错过食物团而导致的高血糖症。利用CGM信号并向胰岛素泵提供输出的算法的安全性和有效性最初将在资助的第3年在CTRC中进行研究。在第4年和第5年，我们计划评估由Abbott Diabetes Care开发的完全非卧床系统中预防低血糖和高血糖的组合算法。我们认为，预防低血糖（尤其是夜间）和降低餐后高血糖将改善血糖控制并降低HbA1c水平。 公共卫生相关性：低血糖是1型糖尿病患者实现最佳血糖控制的主要障碍之一。这项研究的重点是减少1型糖尿病患者餐后低血糖和高血糖。希望这将有助于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.