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

个人移动糖尿病管理系统（PMDMS）：IN-TRACK

• 批准号: 8311248
• 负责人: Gabriela Voskerician
• 金额: $ 24.42万
• 依托单位: KRIKORJAN, INC.
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-08-03 至 2013-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8311248
• 关键词: Accounting; Address; Affect; Age; Algorithms; American; Blood Glucose; Bolus Infusion; Calendar; Carbohydrates; Caring; Circadian Rhythms; Clinical; Clinical Trials; Communication; Computer Simulation; Computer software; Computers; Data; Development; Devices; Diabetes Mellitus; Diagnosis; Dose; Electronics; Ensure; Evaluation; Event; Exercise; Feedback; Glosso-Sterandryl; Goals; Health Insurance Portability and Accountability Act; Hypoglycemia; Image; Injection of therapeutic agent; Insulin; Insulin Infusion Systems; Intake; Internet; Intervention; Language; Lead; Left; Life; Link; Manuals; Measurement; Medical Care Team; Methods; Monitor; Nervous System Trauma; Outcome; Output; Paper; Patients; Performance; Persuasive Communication; Pharmaceutical Preparations; Phase; Physical activity; Population; Protocols documentation; Pump; Quantitative Evaluations; Recommendation; Recording of previous events; Recurrence; Regimen; Reporting; Research Infrastructure; Residual state; Simulate; Solutions; Source; Statistical Methods; Structure; System; Testing; Text; Time; Training; Voice; Weight; basal insulin; base; clinically relevant; cost effective; data modeling; design; diabetes management; diabetic; improved; insulin sensitivity; prevent; programs; research clinical testing; tool; trend

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.

描述（由申请人提供）：在美国被诊断出患有糖尿病的2400万患者中，有650万（27％）取决于严格的胰岛素给药。关键糖尿病护理参数的有限或不可靠的患者报告（血糖测量，碳水化合物摄入量和胰岛素制度）是糖尿病管理不善的主要来源，在美国糖尿病护理中造成1740亿美元/年支出。特别是，与关键糖尿病护理参数的有限跟踪相结合的INACCURAT胰岛素推注计算被认为是复发性降血糖事件的主要原因，导致胰岛素依赖蛋白患者的糖尿病管理不良结果。尽管据报道，配备有能力计算胰岛素推注和跟踪糖尿病护理参数的胰岛素泵的好处，但只有375,000名胰岛素依赖性患者使用它们，这使得大多数需要解决方案的美国人中的大多数。 Krikorjan提出了个人移动糖尿病管理系统：轨道上提供临床准确的计算支持和监测关键糖尿病护理参数，从而增强胰岛素管理治疗。第一阶段将重点放在In-Track的开发上，In-Track是一种胰岛素管理工具，将实时胰岛素推注计算与糖尿病护理参数的历史跟踪，保持活跃的胰岛素和体育活动的历史跟踪，支持患者和医疗团队有效地管理胰岛素治疗，并通过延伸，糖尿病。 I阶段的开发涉及两个目标。 AIM 1将专注于构建能够计算下一个建议的胰岛素推注（SIB）的移动软件程序，并追踪血糖，碳水化合物的摄入量，体育锻炼和剩余的活性胰岛素和胰岛素，并在历史上实时以及历史上。 SIB的准确性 在目标2期间通过比较测试与当前的胰岛素计算方法进行验证：胰岛素泵（REVEL（R）（最小）（最小），Animas（R）（R）（Johnson＆Johnson）和Omnipod（R）（INSULET）（INSULET），电子计算，电子计算（Electronic Computations），电子计算（iPhone insulinculculator”（星期五，freeThere the freeTyle（r）inselle（r）Inselcott（r）Insuct（r）Insuct（abbott）（ABBBOBBOTT）（ABBBOBBOTT）（ABBBOBBOBBOTT）（ABBBOBBOBBOBT） （助理）。对改善胰岛素管理的实用和成本效益的工具的临床需求是由熟悉的移动框架所体现的，该框架需要有限的培训和减轻泵相关的限制，而其实用性则通过限制降压事件及其生命的并发症反映。 公共卫生相关性：轨道内通过提供更好的胰岛素治疗来改善糖尿病治疗的实用且具有成本效益的解决方案，以满足胰岛素依赖蛋白依赖蛋白的94％的需求。通过实时监测血糖测量，碳水化合物摄入，体育锻炼和胰岛素状态，以及患者的快速访问趋势，可以增强其临床准确的胰岛素剂量计算器。 作为临床医生，然后是适当的反馈。内部轨道代表了一种强大的胰岛素管理工具，预计将显着减少降低降​​血症事件并改善整体糖尿病护理。