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: 8733673
• 负责人: Richard Mauritz Bergenstal
• 金额: $ 74.98万
• 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 2017-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8733673
• 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UnitedHealth14，到2020年，所有美国人中有一半将患有糖尿病或糖尿病前，年费用为5000亿美元，主要归因于糖尿病相关的并发症。糖尿病是一种流行病，但很少实现治疗目标，并且患者会忍受有害并发症。在美国，所有胰岛素接受者中有65％（其中大多数患有2型糖尿病）的HBA1C> 7％，因此它们易于并发症。面临的挑战是，实际上胰岛素剂量很少在诊所任命之间滴定27。对掺入不同胰岛素方案的2型和1型糖尿病患者的多项研究表明，胰岛素剂量的频繁滴定是在大多数患者中实现治疗目标的关键元素2-10。不幸的是，没有一个 患者友好，具有成本效益，安全有效的干预措施，可为患者提供频繁的胰岛素滴定，并最大程度地提高胰岛素治疗的潜在益处。 Hygieia开发了糖尿病胰岛素引导系统（DIGS”）软件（以前称为“ Private-Doc”）来自动化胰岛素剂量滴定过程。DIGSDIGS胰岛素调整软件模仿临床医生评估和调整剂量的方式。在I期Project12中，在一项I阶段研究中已证明了16周的临床试验。改善了糖浆对照（较低的HBA1C，平均葡萄糖和低血糖的频率）是要让胰岛素接受者使用D-NAV代替葡萄糖表，以类似的成本，不需要行为变化或增加测试频率，从而导致糖质控制。初级保健医师（PCP），而易于D-NAV葡萄糖测试条的成本却被医疗保险覆盖。在第二阶段，Hygieia试图在前瞻性，开放标签，随机，控制，多中心，6个月的试验中胰岛素治疗的患者招募[200]，使用D-NAV评估胰岛素治疗的疗效和安全性。 [智能] 2型糖尿病患者的葡萄糖仪会随机接受D-NAV或[SMART]葡萄糖仪，通过HBA1C的衰减来测试。目的是建立注册的临床指示，并说服PCP胰岛素疗法与D-NAV相结合是安全有效的。医疗保健系统负担，从而节省了数十亿美元的国家医疗保健费用。