In home closed loop reduction of nocturnal hypoglycemia and daytime hyperglycemia

在家闭环减少夜间低血糖和日间高血糖

• 批准号: 8336881
• 负责人: ROY W. BECK
• 金额: $ 76.59万
• 依托单位: JAEB CENTER FOR HEALTH RESEARCH, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2014-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8336881
• 关键词: 18 year old; 3 year old; Address; Adolescent; Algorithms; Bolus Infusion; Caring; Center for Translational Science Activities; Clinical; Clinical Trials; Coupled; Development; Diabetes Mellitus; Event; Food; Fright; Glucose; Glycosylated hemoglobin A; Goals; Grant; Home environment; Hyperglycemia; Hypoglycemia; Incidence; Infusion Pumps; Insulin; Insulin Infusion Systems; Insulin-Dependent Diabetes Mellitus; Lead; National Institute of Diabetes and Digestive and Kidney Diseases; Outpatients; Output; Participant; Patients; Persons; Prevention; Protocols documentation; Pump; Randomized Clinical Trials; Research; Safety; Secondary to; Signal Transduction; Sleep; Study Section; System; Technology; Testing; Time; basal insulin; base; design; forgetting; glucose monitor; glycemic control; improved; monitoring device; prevent; safety testing; sensor; subcutaneous

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.

摘要 在1型糖尿病（T1D）受试者中实现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推注。两 这些问题将在这笔赠款的五年期间得到解决。超过一半的严重 如果低血糖事件发生在睡眠期间，我们将继续开发算法， 使用闭环系统（CLS）预测和预防夜间低血糖， 来自连续葡萄糖监测器（CGM）的信息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）记录“佛罗伦萨”CLS（Abbott Diabetes Care）的安全性，然后我们将 在补助金的第二年和第三年在家庭环境中进行随机临床试验。 同样，一个完全便携式CLS将用于检测和纠正高血糖症导致的 错过了食物。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3年进行研究。 格兰特.在第4年和第5年，我们计划评估联合预防算法， 在Abbott Diabetes开发的完全非卧床系统中， 在乎我们认为，预防低血糖，特别是在夜间， 餐时高血糖将导致血糖控制改善和HbA1c降低 程度.