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）：在美国诊断为糖尿病的2400万患者中，650万（27%）依赖于严格的胰岛素给药制度。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治疗方案）是糖尿病管理不善的主要原因，导致美国每年在糖尿病护理方面的支出为1740亿美元。特别是，胰岛素剂量计算不准确，加上对关键糖尿病护理参数的追踪有限，被认为是胰岛素依赖患者反复发生低血糖事件的主要原因，导致糖尿病管理结果不佳。尽管有报道称配备胰岛素泵计算胰岛素丸量和跟踪糖尿病护理参数有好处，但只有37.5万胰岛素依赖患者使用它们，这使得610万美国人中的大多数需要一个解决方案。KRIKORJAN提出个人移动糖尿病管理系统：IN-TRACK提供临床准确的计算支持和关键糖尿病护理参数的监测，从而提高胰岛素管理治疗。第一阶段将重点开发in - track，这是一种胰岛素管理工具，它结合了实时胰岛素丸计算和糖尿病护理参数的历史跟踪，剩余活性胰岛素和身体活动，支持患者和医疗团队有效地管理胰岛素治疗，并扩展到糖尿病。第一阶段的发展有两个目的。目标1将专注于建立一个移动软件程序，能够计算下一个建议的胰岛素剂量（SIB），并跟踪血糖、碳水化合物摄入量、身体活动和剩余活性胰岛素，以及实时和历史的胰岛素。SIB的准确性