Personal Mobile Diabetes Management System(PMDMS): IN-TRACK

描述(由申请人提供)：在美国2400万被诊断为糖尿病的患者中，650万(27%)依赖于严格的胰岛素注射制度。有限或不可靠的患者报告的关键糖尿病护理参数(血糖测量、碳水化合物摄入量和胰岛素方案)是糖尿病管理不善的主要来源，导致美国每年在糖尿病护理方面的支出为1,740亿美元。特别是，胰岛素推注计算的不准确，加上对关键糖尿病护理参数的有限跟踪，被认为是导致胰岛素依赖患者糖尿病管理结果不佳的反复低血糖事件的主要原因。尽管据报道，配备了胰岛素泵来计算胰岛素推量和跟踪糖尿病护理参数的好处，但只有37.5万名胰岛素依赖症患者使用它们，让610万美国人中的大多数需要解决方案。KRIKORJAN提出个人移动糖尿病管理系统：提供临床上准确的计算支持和关键糖尿病护理参数的监控，从而加强胰岛素管理治疗。第一阶段将重点开发IN-Track，这是一种胰岛素管理工具，它结合了对糖尿病护理参数、剩余有效胰岛素和体力活动的历史跟踪的实时胰岛素推注计算，支持患者和保健团队有效地管理胰岛素治疗，进而管理糖尿病。这一第一阶段的发展涉及两个目标。目标1将专注于构建一个移动软件程序，该程序能够计算下一个建议的胰岛素推注(SIB)，并实时和历史地跟踪血糖、碳水化合物摄入量、体力活动和剩余的活性胰岛素以及胰岛素。SIB的准确性 在AIM 2期间，将通过与目前的胰岛素计算方法进行比较测试来验证计算结果：胰岛素泵(Revel(R)(MiniMed)、Animas(R)(Johnson&Johnson)和OmniPod(R)(Insulet))、电子计算(iPhone InsulinCalculator“(星期五开始))、Freestyle(R)InsuLinx(雅培))和纸质协议(纸轮InsuCalc”(InsuCalc.com))。在第二阶段，一项临床试验将评估In-Track预防胰岛素“堆积”(在短时间内给予几次推注，导致胰岛素活性重叠)和相关的降低低血糖事件的潜力。额外的跟踪、即时支持和劝说能力将被纳入，以满足患者和临床团队在临床评估中出现的需求。In-Track建立在患者和临床对实用和经济有效的工具的需求基础上，以改善胰岛素管理。它的实用性体现在人们熟悉的移动框架上，建立在这种框架上需要有限的培训，并减轻与泵相关的限制，而其有用性则体现在限制低血糖事件及其危及生命的并发症上。 公共卫生相关性：In-Track通过更好的胰岛素管理为改善糖尿病治疗提供实用且经济高效的解决方案，从而满足94%的胰岛素依赖型糖尿病人口的需求。其临床上精确的胰岛素剂量计算器通过实时监测血糖测量、碳水化合物摄入量、体力活动和胰岛素状态，以及患者快速获取趋势来增强 作为临床医生，随后进行适当的反馈。In-Track代表了一种强大的胰岛素管理工具，预计它将显著减少低血糖事件，并改善整体糖尿病护理。

DESCRIPTION (provided by applicant): Of the 24 million patients diagnosed with diabetes in the US, 6.5 million (27%) depend on a strict regime of insulin administration. Limited or unreliable patient reporting of critical diabetes care parameters (blood glucose measurements, carbohydrate intake, and insulin regime) is the leading source of diabetes mismanagement contributing to the $174 billion/year spending in diabetes care in the US. In particular, inaccurat insulin bolus computation in combination with limited tracking of critical diabetes care parameters is recognized as a principal cause of recurrent hypoglycemic events leading to poor diabetes management outcomes in insulin dependent patients. Despite the reported benefits of insulin pumps equipped to calculate insulin bolus and track diabetes care parameters, only 375,000 insulin dependent patients use them, leaving the majority of 6.1 million Americans in need of a solution. KRIKORJAN proposes Personal Mobile Diabetes Management System: IN-TRACK to deliver clinically accurate computation support and monitoring of critical diabetes care parameters leading to enhanced insulin management treatment. Phase I will focus in the development of IN-TRACK, an Insulin Management tool that incorporates a real-time insulin bolus computation with history tracking of diabetes care parameters, remaining active insulin, and physical activity, supporting the patient and the healthcare team in effectively managing insulin treatment and, by extension, diabetes. This Phase I development involves two Aims. Aim 1 will focus on building of a mobile software program capable of computing the next suggested insulin bolus (SIB) and tracking blood glucose, carbohydrate intake, physical activity, and remaining active insulin, and insulin in real-time as well as historically. The accuracy of SIB computation will be validated during Aim 2 via comparison testing against current insulin computation methods: insulin pumps (Revel(R) (MiniMed), Animas(R) (Johnson & Johnson), and OmniPod(R) (Insulet), electronic computations (the iPhone InsulinCalculator" (Friday Forward), the FreeStyle(R) InsuLinx (Abbott)) and paper protocols (paper wheel InsuCalc" (InsuCalc.com)). In Phase II, a clinical trial will evaluate the IN- TRACK potential to prevent insulin "stacking" (several boluses given in a short period of time leading to overlapping insulin activity) and associated reduction in hypoglycemic events. Additional tracking and just-in- time support and persuasion capabilities will be incorporated to address patient and clinical team needs emerging from the clinical evaluation. IN-TRACK builds on the patient and clinical need for practical and cost-effective tools to improve insulin management. Its practicability is embodied by the familiar mobile framework onto which is built requiring limited training and alleviating pump related limitations, while its usefulness is reflected by limiting hypoglycemic events and their life-threatening complications. PUBLIC HEALTH RELEVANCE: IN-TRACK addresses the needs of 94% of the insulin dependent diabetic population by offering a practical and cost-effective solution to improved diabetes treatment through better Insulin Management. Its clinically accurate insulin dose calculator is enhanced by real-time monitoring of blood glucose measurements, carbohydrate intake, physical activity, and insulin regime, along with quick access to trends by patient as well as clinician, followed by appropriate feedback. IN-TRACK represents a powerful Insulin Management tool which is expected to significantly reduce hypoglycemic incidents and improve overall diabetes care.