Automatic Insulin Dosage Adjustment to Improve Glycemic Control of Diabetic Patie

描述（由申请人提供）：糖尿病已成为一种日益增长的流行病，但治疗目标很少实现，患者忍受有害的并发症。胰岛素是唯一的剂量依赖性抗糖尿病药物，大多数患者可以达到平衡的血糖水平时，适当的剂量规定。尽管如此，只有当胰岛素剂量经常滴定时，药物的全部益处才能实现。患者需求和护理人员可用性之间的不匹配阻碍了频繁的胰岛素剂量滴定。EQUEIA INC.正在开发一种名为“私人医生”的设备，旨在供需要胰岛素的糖尿病患者使用。Private-Doc将是一个口袋大小的设备，将血糖仪与嵌入式专有算法软件相结合，该软件分析记录在设备存储器中的血糖水平，并定期建议修改胰岛素剂量。已经开发的软件算法是基于内分泌学家评估和频繁调整糖尿病患者胰岛素的方式。使用强化胰岛素治疗试验的历史数据对算法效用进行了回顾性评价。与市场上的其他血糖仪一样，Pakeia打算免费向患者分发Private-Doc，而消耗性血糖试纸的费用将由医疗保险支付。在第一阶段，Pneumeia试图在一项为期16周的临床安全性和有效性研究中前瞻性地证实Private-Doc的软件，包括60名1型和2型糖尿病患者，他们已经接受胰岛素治疗，但代谢控制不良。在试验的前4周（对照期），将由入组患者记录每日葡萄糖水平和胰岛素剂量，而不改变其胰岛素剂量。在接下来的12周实验期间，将根据Private-Doc软件算法的建议并由研究团队传达，每周向患者提供胰岛素剂量调整。将通过血红蛋白A1 C、果糖胺和平均每周血糖数据评估胰岛素剂量调整的疗效。安全性将通过低血糖发生频率进行确认。Questeia假设Private-Doc软件将有效和安全地优化需要胰岛素的1型和2型糖尿病患者的血糖控制。在第一阶段验证概念的可行性后，将在第二阶段测试包含专有软件的原型手持设备在家庭环境中的安全性和有效性。我们相信，一旦Private-Doc广泛用于需要胰岛素的糖尿病患者，个体化胰岛素剂量优化器装置的总体医疗益处将是降低糖尿病并发症的发生率，减轻卫生系统负担，从而潜在地节省数十亿美元的国家卫生保健成本。 公共卫生相关性：尽管为实现平衡血糖控制付出了巨大努力，但仍有数百万接受胰岛素治疗的糖尿病患者血糖水平较高，并发生毁灭性并发症，每年的费用巨大。Escheia Research开发了一种新的软件，回顾性地证明，该软件能够以与一组专家内分泌学家相似的方式优化患者的胰岛素剂量。这项研究将测试软件前瞻性治疗糖尿病患者的能力，从而开发出一种智能血糖仪，积极帮助医生管理患者，减少疾病并发症，并节省数十亿纳税人的医疗保健费用。

DESCRIPTION (provided by applicant): Diabetes has become a growing epidemic, yet treatment goals are seldom achieved, and patients endure detrimental complications. Insulin is the only dose-dependent antidiabetic medication in which most patients can accomplish balanced blood glucose levels when adequate dosages are prescribed. Nonetheless, only when insulin dosage is frequently titrated, is the full benefit of the drug realized. The mismatch between patients' needs and caregivers' availability prohibit frequent insulin dosage titrations. Hygieia INC. is developing a device called the "Private-Doc", intended for use by insulin-requiring diabetic patients. Private-Doc will be a pocket-size device, combining a glucose meter with embedded proprietary algorithmic software that analyzes blood glucose levels recorded in the device's memory, and periodically recommends modifications in insulin dosage. The already developed software algorithms are based on the way an endocrinologist evaluates and frequently adjusts insulin in a diabetic patient. The algorithms utility has been evaluated retrospectively using historical data from an intensive insulin therapy trial. Like other glucose meters on the market, Hygieia intends to distribute Private-Doc without cost to the patient, while the cost of consumable glucose test strips will be covered by the medical insurance. In Phase I, Hygieia seeks to prospectively corroborate Private-Doc's software in a 16-week clinical safety and efficacy study, including 60 Type-1 and Type-2 diabetic patients, who are already on insulin therapy, but have poor metabolic control. During the first 4 weeks of the trial (the control period), daily glucose levels and insulin dosages will be documented by the enrolled patients, without modifying their insulin dosages. During the 12-week experimental period that follows, patients will be provided with weekly insulin dosage modifications as recommended by Private-Doc's software algorithms and communicated by the study-team. Efficacy of the insulin dosage modifications will be assessed by hemoglobin A1C, fructosamine and mean weekly glucose data. Safety will be confirmed by frequency of hypoglycemia. Hygieia hypothesizes that Private-Doc software will effectively and safely optimize glucose control in insulin-requiring type-1 and type-2 diabetic patients. Upon validating feasibility of the concept in Phase I, , a prototype hand-held device containing the proprietary software will be tested for safe and effective use by the patients in the home setting in Phase II. We believe that once Private-Doc becomes widely available to insulin- requiring diabetic patients, the overall medical benefit of the individualized insulin dosage optimizer device will be to reduce the incidence of diabetic complications, to alleviate the health system burden and thus potentially save billions of dollars in national health care costs. PUBLIC HEALTH RELEVANCE: Despite immense effort to achieve balanced glucose control, millions of insulin-treated diabetic patients have high glucose levels and develop devastating complications at tremendous annual cost. Hygieia Research developed novel software retrospectively proven capable of optimizing patient's insulin dosage in a similar manner to a group of expert endocrinologists. This study will test the software ability to prospectively treat diabetic patients, thus leading to the development of an intelligent glucose meter that will actively help physicians manage patients, reduce complications of the disease, and save billions of tax payer dollars in health care costs.