Automatic Insulin Dosage Adjustment to Improve Glycemic Control of Diabetic Patie

自动调整胰岛素剂量以改善糖尿病患者的血糖控制

基本信息

批准号：
7808133
负责人：
Richard Mauritz Bergenstal
金额：
$ 34.29万
依托单位：
HYGIEIA RESEARCH, LLC
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-06-10 至 2011-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7808133
关键词：
Achievement Adult Algorithms Antidiabetic Drugs Apple Appointment Biomedical Research Blood Glucose Blood Glucose Self-Monitoring Boston Brain Carbohydrates Caregivers Caring Charge Chronic Disease Clinic Clinic Visits Clinical Clinical Research Clinical Trials Complications of Diabetes Mellitus Computer software Computers Data Data Analyses Decision Making Development Devices Diabetes Mellitus Diagnosis Disease Disease Management Doctor of Philosophy Dose Eating Electrical Engineering Electronics Endocrinologist Endocrinology Enrollment Epidemic Equilibrium FDA approved Face Faculty Frequencies Fructosamine Future Glucose Glycosylated hemoglobin A Goals Guidelines Hand Health Care Costs Health Personnel Health system Hemoglobin Home environment Human Hypoglycemia Incidence Income Individual Industry Infusion Pumps Instruction Insulin Insurance Internal Medicine International Internet Intervention Israel Knowledge Laws Lead Legal patent Manufacturer Name Marketing Measures Mediation Medical Memory Metabolic Control Michigan Modeling Modification Monitor Mus Non-Insulin-Dependent Diabetes Mellitus Patients Pharmaceutical Preparations Phase Physician Executives Physicians Population Primary Care Physician Procedures Process Production Pump Quality of Care Recommendation Recording of previous events Regimen Research Research Personnel Rights Risk Safety Sales Self Management Self-Administered Simulate Solutions Study Section System Taxes Technology Testing Therapeutic Therapy Clinical Trials Time Titrations Training Treatment Protocols Universities base blood glucose regulation commercialization cost design diabetic diabetic patient dosage expectation experience glucose monitor glycemic control improved international center medical schools member meter novel phase 1 study phase 2 study prospective prototype public health relevance research and development software development subcutaneous technological innovation week trial

项目摘要

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.

描述（由申请人提供）：糖尿病已成为一种日益流行的疾病，但治疗目标却很少实现，而且患者还要忍受有害的并发症。胰岛素是唯一一种剂量依赖性抗糖尿病药物，大多数患者在服用足够剂量时可以达到平衡的血糖水平。尽管如此，只有经常调整胰岛素剂量，才能充分发挥药物的作用。患者的需求和护理人员的可用性之间的不匹配阻碍了频繁的胰岛素剂量滴定。 Hygieia INC.正在开发一种名为“Private-Doc”的设备，旨在供需要胰岛素的糖尿病患者使用。 Private-Doc 将是一款袖珍设备，将血糖仪与嵌入式专有算法软件相结合，分析设备内存中记录的血糖水平，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该算法的实用性进行了回顾性评估。与市场上其他血糖仪一样，Hygieia 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承担。在第一阶段，Hygieia 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，该研究包括 60 名已经接受胰岛素治疗但代谢控制不佳的 1 型和 2 型糖尿病患者。在试验的前 4 周（对照期），入组患者将记录每日血糖水平和胰岛素剂量，而不修改其胰岛素剂量。在接下来的 12 周实验期间，将按照 Private-Doc 软件算法的建议并由研究团队传达，每周为患者提供胰岛素剂量修改。胰岛素剂量调整的效果将通过糖化血红蛋白、果糖胺和平均每周血糖数据进行评估。安全性将通过低血糖的频率来确认。 Hygieia 假设 Private-Doc 软件将有效、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。在第一阶段验证该概念的可行性后，将在第二阶段测试包含专有软件的原型手持设备，以供患者在家中安全有效地使用。我们相信，一旦 Private-Doc 广泛为需要胰岛素的糖尿病患者提供，个体化胰岛素剂量优化器设备的总体医疗效益将是减少糖尿病并发症的发生率，减轻卫生系统的负担，从而可能节省数十亿美元。美元的国家医疗保健费用。公共健康相关性：尽管为实现平衡血糖控制付出了巨大努力，但数以百万计接受胰岛素治疗的糖尿病患者的血糖水平很高，并出现毁灭性的并发症，每年花费巨大。 Hygieia Research 开发的新型软件经回顾证明能够以与内分泌专家组类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，它将积极帮助医生管理患者，减少疾病并发症，并为纳税人节省数十亿美元的医疗保健费用。