A probabilistic closed-loop artificial pancreas to handle unannounced meals

概率闭环人工胰腺处理突击餐

• 批准号: 8674837
• 负责人: B. WAYNE BEQUETTE
• 金额: $ 39.89万
• 依托单位: RENSSELAER POLYTECHNIC INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-04-11 至 2017-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8674837
• 关键词: Algorithms; Ambulatory Monitoring; Artificial Pancreas; Autoimmune Process; Beta Cell; Blood Glucose; Caring; Cessation of life; Chronic; Clinic; Clinical; Clinical Research; Collaborations; Coma; Development; Devices; Diabetes Mellitus; Disease; Dose; Drops; Eating; Enrollment; Evaluation; Exercise; Exercise stress test; Fingers; Food; Glucose; Goals; Health; Home environment; Hospitals; Hour; Hyperglycemia; Hypoglycemia; Individual; Infusion Pumps; Infusion procedures; Injection of therapeutic agent; Inpatients; Institutes; Insulin; Insulin Infusion Systems; Insulin-Dependent Diabetes Mellitus; Intervention; Life Style; Measures; Metabolic Diseases; Microvascular Dysfunction; Moderate Exercise; Monitor; Motion; Outpatients; Pancreas; Patients; Performance; Physiological; Plastics; Preparation; Pump; Replacement Therapy; Research; Safety; Seizures; Skin; Sleep; Suspension substance; Suspensions; System; Testing; Time; Tube; Uncertainty; Universities; Virginia; Work; base; blood glucose regulation; care burden; cost; design; glucose monitor; glucose sensor; improved; laptop; macrovascular disease; novel; programs; safety testing; sensor; subcutaneous; sugar

DESCRIPTION (provided by applicant): Type 1 diabetes is a condition caused by destruction of the pancreas' ability to produce insulin. This results in lifelong insulin requirement. This condition is treated with insulin injections or by a pump that pumps insulin continuously through a small plastic tube that sits under the skin. Currently, insulin doses need to be worked out by the patient depending on their finger-stick blood glucose level and the sugar content in their food. The development of an artificial pancreas that can manage all of this automatically by measuring glucose levels and working out how much insulin to give, would greatly change the treatment of diabetes. The aim of this study is to further develop an artificial pancreas system which we have developed and studied in a small group of patients. Our initial results were encouraging and we were able to control glucose levels within an acceptable level during the day and night. Our system will consist of an insulin pump, glucose sensor and smartphone with a calculator, which determines how much insulin to give by a special formula. Through this study, we hope to make the system better by adding an accelerometer that can measure how active a patient is. The system can then change insulin delivery depending on activity levels. It will also be able to tell when you are sleeping and adjust insulin for this. Our system will be designed so that the patient does not have to tell us about meals or exercise. This is a true, automatic, artificial pancreas for both day and night time. We will incorporate special formulas and information that we know already about, such as timing of meals and exercise, to improve the performance of the system. In this study, we will initially test the system in a group of 20 patients in hospital with type 1 diabetes to see how well the system can work in managing glucose levels. We will use the results to make further improvements to our system. When the system is working well, we will continue testing the system in another group of 20 patients over 4 days in a hotel setting with remote monitoring. Towards the end of this program, we will test the system in a group of 12 patients using the system at home for 2 weeks with remote monitoring.

描述(由申请人提供)：1型糖尿病是一种由于胰腺产生胰岛素的能力被破坏而引起的疾病。这会导致终生需要胰岛素。这种情况可以通过注射胰岛素或通过皮下的小塑料管持续泵入胰岛素来治疗。目前，胰岛素剂量需要由患者根据手指粘连的血糖水平和食物中的糖含量来计算。人工胰腺的开发将极大地改变糖尿病的治疗方法，这种人工胰腺可以通过测量血糖水平并计算出应该提供多少胰岛素来自动管理所有这些。这项研究的目的是进一步开发一种人工胰腺系统，我们已经在一小部分患者中开发和研究了该系统。我们的初步结果令人鼓舞，我们能够在白天和晚上将血糖水平控制在可接受的水平。我们的系统将由胰岛素泵、葡萄糖传感器和带有计算器的智能手机组成，计算器可以通过特殊的公式确定要给多少胰岛素。通过这项研究，我们希望通过增加一个可以测量患者活动程度的加速度计，使系统变得更好。然后，该系统可以根据活动水平改变胰岛素的释放。它还将能够判断你什么时候在睡觉，并为此调整胰岛素。我们的系统将被设计成患者不必告诉我们关于饮食或锻炼的事情。这是一个真正的，自动的，人工的胰腺，白天和晚上都可以。我们将纳入我们已经知道的特殊配方和信息，如进餐时间和锻炼，以改善系统的性能。在这项研究中，我们将首先在20名住院的1型糖尿病患者中测试该系统，看看该系统在管理血糖水平方面的效果如何。我们将利用结果对我们的系统进行进一步的改进。当系统运行良好时，我们将在酒店的另一组20名患者中继续测试该系统，为期4天，并进行远程监控。在这个项目接近尾声的时候，我们将在12名患者中测试该系统，在家中使用该系统2周，并进行远程监测。