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）：根据UnitedHealth 14，到2020年，一半的美国人将患有糖尿病或糖尿病前期，每年花费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。在美国，65%的胰岛素使用者（其中大多数患有2型糖尿病）的HbA 1c>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临床治疗之间滴定27。对2型和1型糖尿病患者进行的采用不同胰岛素方案的多项研究显示，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，没有单一的， 患者友好、经济、安全和有效的干预措施，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。Diabetes Insulin Guidance System（DIGS）软件（以前称为“Private-Doc”）是由Diabetes Insulin Guidance System（DIGS）开发的，用于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。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12。在I期研究中，DIGS软件每周滴定38例1型和2型糖尿病成人的胰岛素治疗，改善了乙醇酸控制（降低HbA 1c、平均血糖和低血糖频率）。D-Nav是一种手持式设备，将血糖仪与DIGS软件结合起来，分析血糖模式并定期调整用户的胰岛素剂量。目标是让胰岛素使用者使用d-Nav代替血糖仪，以类似的成本，不需要行为改变或增加测试频率，从而实现上级乙醇酸控制。d-Nav DIGS将由初级保健医生（PCP）免费提供给患者，而消耗性d-Nav葡萄糖试纸的费用由医疗保险支付。在第二阶段，Pneumeia寻求招募[200]名接受胰岛素治疗的患者参加一项前瞻性、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”与[智能]血糖仪相比胰岛素治疗2型糖尿病患者的疗效和安全性。入组后，患者将随机接受d-Nav或[智能]血糖仪。疗效将通过HbA 1c的衰减进行检验，安全性将通过低血糖的频率和严重程度进行检验。目的是确定注册的临床适应症，并说服PCP胰岛素治疗联合d-Nav是安全有效的。我们相信，一旦d-Nav广泛用于胰岛素使用者，胰岛素剂量的优化将降低糖尿病并发症的发生率，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。