Diabetes Insulin Guidance System to Improve Glycemic Control of Diabetic Patients

描述(由申请人提供)：根据UnitedHealth14，到2020年，一半的美国人将患有糖尿病或糖尿病前期，年成本为5000亿美元-主要归因于糖尿病相关并发症。糖尿病是一种日益流行的疾病，但治疗目标很少实现，患者承受着有害的并发症。在美国，65%的胰岛素接受者(其中大多数患有2型糖尿病)患有7%的糖化血红蛋白，因此他们容易出现并发症。挑战在于，在现实中，胰岛素剂量很少在两次临床预约之间进行滴定。对合并不同胰岛素方案的2型和1型糖尿病患者的多项研究表明，在大多数患者2-10中，胰岛素剂量的频繁滴定是实现治疗目标的关键因素。不幸的是，没有单曲， 对患者友好、经济高效、安全有效的干预措施，为患者提供频繁的胰岛素滴定，并最大限度地发挥胰岛素治疗的潜在好处。Hygieia开发了糖尿病胰岛素指导系统(DIGS)软件(以前称为“Private-Doc”)，以自动化胰岛素剂量滴定过程。Digs胰岛素调整软件模拟临床医生评估和调整剂量的方式。在第一阶段STTR项目12期间，DIGS软件的实用性已经在一项为期16周的前瞻性临床试验中得到了证明。在第一阶段的研究中，DIGS软件每周对38名患有1型和2型糖尿病的成人患者进行胰岛素治疗，结果改善了糖耐量控制(较低的HbA1c、平均血糖和低血糖频率)。Hygieia进一步开发了d-Nav，这是一种手持设备，将血糖仪与DIGS软件相结合，可以分析血糖模式并定期调整用户的胰岛素剂量。其目标是让胰岛素服用者使用d-Nav而不是血糖仪，成本相似，不需要改变行为或增加测试频率，从而实现更好的血糖控制。D-Nav试纸将由患者的初级保健医生(PCP)免费提供，而消耗性d-Nav葡萄糖试纸的费用则由医疗保险支付。在第二阶段，Hygieia寻求招募[200]名接受胰岛素治疗的患者，进行一项前瞻性、开放标签、随机、对照、多中心、为期6个月的试验，评估在2型糖尿病患者中使用d-Nav和[SMART]血糖仪进行胰岛素治疗的有效性和安全性。在登记后，患者将随机接受d-Nav或[智能]血糖仪。疗效将通过HbA1c的衰减来测试，安全性将通过低血糖的频率和严重程度来测试。其目的是建立注册的临床指征，并说服PCPS胰岛素联合d-Nav治疗是安全有效的。我们相信，一旦d-Nav广泛应用于胰岛素服用者，优化胰岛素剂量将减少糖尿病并发症的发生率，减轻医疗系统负担，从而节省数十亿美元的国家医疗成本。

DESCRIPTION (provided by applicant): According to UnitedHealth14 by 2020 half of all Americans would have either diabetes or pre-diabetes with an annual cost of $500 billion - mainly attributed to diabetes related complications. Diabetes is a growing epidemic yet treatment goals are seldom achieved, and patients endure detrimental complications. In the US, 65% of all insulin takers (most of which have type-2 diabetes) have HbA1c>7% and thus they are susceptible to complications. The challenge is that in reality insulin dosage is rarely titrate between clinic appointments27. Multiple studies with patients with type-2 and type-1 diabetes incorporating different insulin regimens showed frequent titration of insulin dosage is the key element to achieve therapy goal in the majority of patients2-10. Unfortunately, there is no single, patient-friendly, cost-effective, safe and effective intervention that provides frequent insulin titration to patients and maximizes the potential benefits of insulin therapy. Hygieia developed the Diabetes Insulin Guidance System (DIGS") software (formerly called "Private-Doc") to automate the process of insulin dosage titration. The DIGS insulin adjustment software emulates the way clinicians evaluate and adjust dosage. The utility of the DIGS software has been demonstrated in a prospective 16-week clinical trial during the Phase I STTR project12. In the Phase I study, the DIGS software titrated insulin therapy of 38 adults with type-1 and type-2 diabetes, on a weekly basis, resulting in improved glycolic control (lower HbA1c, mean glucose, and frequency of hypoglycemia). Hygieia further developed d-Nav, a handheld device, combining a glucose meter with the DIGS software that analyzes blood glucose patterns and periodically adjust the user's insulin dosage. The goal is to have insulin takers use d-Nav instead of a glucose meter, at a similar cost and requiring no behavioral changes or increased testing frequency, leading to superior glycolic control. The d-Nav DIGS will be given to patients free of charge by their primary care physician (PCP), while the cost of consumable d-Nav glucose test strips is covered by medical insurance. In Phase II, Hygieia seeks to recruit [200] insulin treated patients in a prospective, open-label, randomized, controlled, multi-center, 6- month trial assessing the efficacy and safety of insulin therapy using d-Nav" compared to a [smart] glucose meters in patients with type-2 diabetes. Upon enrollment patients will be randomized to either receive d-Nav or a [smart] glucose meter. Efficacy will be tested by attenuation in HbA1c and safety by the frequency and severity of hypoglycemia. The objectives are to establish clinical indication for registration and convince PCPs insulin therapy combined with d-Nav is safe and effective. We believe once d-Nav becomes widely available to insulin takers, optimization of insulin dosage will reduce incidence of diabetic complications and alleviate the health care system burden, thus saving billions of dollars in national health care costs.