Diabetes Insulin Guidance System to Improve Glycemic Control of Diabetic Patients

糖尿病胰岛素指导系统可改善糖尿病患者的血糖控制

• 批准号: 8520789
• 负责人: Richard Mauritz Bergenstal
• 金额: $ 74.95万
• 依托单位: HYGIEIA RESEARCH, LLC
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-06-10 至 2015-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8520789
• 关键词: Adult; American; Award; Behavioral; Blood Glucose; Caring; Charge; Clinic; Clinic Visits; Clinical; Clinical Research; Clinical Trials; Companions; Complications of Diabetes Mellitus; Computer software; Devices; Diabetes Mellitus; Disease; Disease Outcome; Economics; Elements; Enrollment; Environment; Epidemic; Equilibrium; Event; Exhibits; Federal Government; Frequencies; Glucose; Glycosylated hemoglobin A; Goals; Health Care Costs; Health Personnel; Healthcare Systems; Home environment; Hypoglycemia; Incidence; Individual; Insulin; Insurance; Intervention; Israel; Knowledge; Medical; Metabolic Control; Modification; National Institute of Diabetes and Digestive and Kidney Diseases; Non-Insulin-Dependent Diabetes Mellitus; Outcome; Patients; Pattern; Pharmaceutical Preparations; Phase; Positioning Attribute; Prediabetes syndrome; Primary Care Physician; Problem Solving; Process; Prospective Studies; Randomized; Recommendation; Recruitment Activity; Regimen; Reporting; Research; Safety; Savings; Secondary to; Severities; Small Business Technology Transfer Research; Solutions; System; Taxes; Testing; Titrations; United States National Institutes of Health; attenuation; base; blood glucose regulation; commercial application; cost; cost effective; diabetes control; diabetes management; diabetic patient; dosage; effective intervention; glucose monitor; glucose sensor; glycemic control; improved; innovation; medication compliance; meter; open label; phase 1 study; prospective; public health relevance; software systems; standard of care; success; technological innovation; tool; type I and type II diabetes; virtual

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.

描述（由申请人提供）：据 UnitedHealth14 称，到 2020 年，一半的美国人将患有糖尿病或糖尿病前期，每年造成的损失达 5,000 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，患者还要忍受有害的并发症。在美国，65% 的胰岛素服用者（其中大多数患有 2 型糖尿病）的 HbA1c>7%，因此他们容易出现并发症。挑战在于，实际上胰岛素剂量很少在两次临床预约之间进行滴定27。对 2 型和 1 型糖尿病患者采用不同胰岛素治疗方案的多项研究表明，频繁调整胰岛素剂量是大多数患者实现治疗目标的关键因素2-10。不幸的是，没有一个， 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益处。 Hygieia 开发了糖尿病胰岛素指导系统 (DIGS") 软件（以前称为“Private-Doc”）来自动执行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。DIGS 软件的实用性已在 I 期 STTR 项目期间的一项为期 16 周的前瞻性临床试验中得到证实。 在 I 期研究中，DIGS 软件对 38 名 1 型和 1 型成人患者进行了滴定胰岛素治疗。 Hygieia 进一步开发了 d-Nav，一种手持设备，将血糖仪与分析血液的 DIGS 软件结合在一起。血糖模式并定期调整用户的胰岛素剂量，目标是让胰岛素服用者以相似的成本使用 d-Nav 代替血糖仪，并且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 DIGS 将由患者的初级保健医生 (PCP) 免费提供给患者，而消耗性 d-Nav 血糖试纸的费用则由医疗保险承担。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，评估使用 d-Nav 的胰岛素治疗的有效性和安全性。 2 型糖尿病患者的 [智能] 血糖仪入组后，患者将被随机分配接受 d-Nav 或 [智能] 血糖仪，通过 HbA1c 的衰减和频率和安全性进行测试。目标是确定注册的临床适应症并说服 PCP 胰岛素治疗与 d-Nav 联合使用是安全有效的。我们相信，一旦 d-Nav 广泛应用于胰岛素使用者，优化胰岛素剂量将降低糖尿病的发生率。并发症并减轻医疗保健系统的负担，从而节省数十亿美元的国家医疗保健费用。