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: 7939702
• 负责人: ROY W. BECK
• 金额: $ 75.82万
• 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/7939702
• 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）：在患有1型糖尿病（T1D）受试者中达到尤格血糖的两个主要问题是低血糖（包括对严重低血糖的恐惧）和美al后高血糖。后者通常发生在接下来是遗体和零食胰岛素大力的青少年中。这两个问题将在这笔赠款的五年内解决。由于睡眠期间发生了超过一半的严重降血糖事件，因此我们将继续使用闭环系统（CLS）（CLS）来预测和预防夜间低血糖，其中使用连续葡萄糖监测仪（CGM）的信息用于胰岛素泵暂停胰岛素的胰岛素递送。初步研究将在临床转化研究中心（CTRC）中进行，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2年和第3年中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来检测和纠正因遗漏食物的质量而导致的高血糖。使用信号形成CGM并为胰岛素泵提供输出的算法的安全性和功效最初将在赠款的第3年中研究。在这笔赠款的第4年和第5年中，我们计划评估预防雅培糖尿病护理完全卧床系统中预防低血糖和高血糖的综合算法。我们认为，预防低血糖，尤其是在夜间，以及降低促春时高血糖的降低将导致血糖控制和HBA1C水平降低的改善。 公共卫生相关性：低血糖是为1型糖尿病患者获得最佳血糖控制的主要威慑力量之一。这项研究的重点是减少1型糖尿病患者饮食后的低血糖和高血糖。希望这将导致参与者的血糖控制改善。