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: 8207373
• 负责人: ROY W. BECK
• 金额: $ 11.4万
• 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 2012-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8207373
• 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; public health relevance; safety testing; sensor; subcutaneous

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.

描述（由申请人提供）：1型糖尿病（T1D）患者实现血糖正常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，继发于错过膳食和零食胰岛素丸。这两个问题将在这笔拨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，我们将继续开发算法来预测和预防夜间低血糖，使用闭环系统（CLS），其中使用连续血糖监测仪（CGM）的信息来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（CTRCs）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2年和第3年在家庭环境中进行随机临床试验。同样，一个完全便携式的CLS将用于检测和纠正因食物遗漏而导致的高血糖。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将在资助的第三年在CTRC中进行初步研究。在该资助的第4年和第5年，我们计划在雅培糖尿病护理公司开发的全动态系统中评估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，减少餐后高血糖，将改善血糖控制和降低HbA1c水平。