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Adapting wireless glucometer to boost opioid dependence medication compliance

采用无线血糖仪提高阿片类药物依赖性药物依从性

基本信息

批准号：
8523553
负责人：
Tian Lan
金额：
$ 19.3万
依托单位：
GLUCOSENTIENT, INC.
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-04-15 至 2015-03-14
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8523553
关键词：
AIDS/HIV problem American Antibodies Award Binding Buffers Buprenorphine Creatinine Crime Data Analyses Detection Development Devices Diagnostic Drug Prescriptions Drug usage Electronics Ensure Enzymes FDA approved Foundations Glucose Goals Health Health Care Costs Healthcare Heroin Home environment Hospitals Hydrocodone Illicit Drugs Illinois Infection Invertase Legal patent Licensing Marketing Measures Medical Methods Monitor Narcotics Opiate Addiction Opioid Outcome Oxycodone Patients Pharmaceutical Preparations Phase Play Preclinical Drug Evaluation Process Recruitment Activity Relapse Reporting Research Role Sampling Signal Transduction Solutions Substance Use Disorder Substance of Abuse Sucrose Symptoms Taxes Technology Test Result Testing Time Treatment outcome United States Universities Urine Violence Visit Wireless Technology Work addiction base commercial application cost drug testing effective therapy glucose monitor improved innovation interest medication compliance meetings member patient privacy performance tests prescription opioid abuse prevent prototype public health relevance screening social transmission process trend user-friendly

项目摘要

DESCRIPTION: Substance use disorder (SUD) is a major health problem with direct and indirect impact on healthcare and societal cost that is estimated at over $181 billion annually in the United States. Opioids are the second most abused substances and buprenorphine (BUP) is an effective and safe medication for opioid dependence. However, BUP remains a narcotic, and strict BUP compliance is critical for patients to obtain the best treatment outcome, prevent relapse, and avoid medication diversion. Compliance is commonly monitored by periodic and random urine tests at hospital visits. However, due to long intervals between each periodic urine drug test, high cost and intrusiveness of random drug testing of a patient, such a measure has not been sufficient to prevent the diversion of BUP for unintended use. Therefore random urine drug tests that are inexpensive, convenient to use, and provide real time test results to doctors while maintaining the privacy of the patients will boost medication compliance. While many methods have been developed for the urine tests and for electronic monitoring, few test technologies meet all of the above requirements, likely due to the fact that new POC devices are costly to develop and expensive to manufacture, particularly when the devices are new to the market. To overcome this limitation, Prof. Yi Lu's group at the University of Illinois has reported a discovery that allows repurposing the widely available and low-cost personal glucose meter (PGM) for detecting many non- glucose targets. The innovation lies in converting the binding of non-glucose target (e.g. BUP) by its antibody to releasing the enzyme invertase which can hydrolyze sucrose into glucose and then quantified by PGM. Through this SHIFT award, we propose to transform the patent-pending discovery into commercial products. Through licensing the technology and recruiting two key members of the Lu group, GlucoSentient, Inc. plans to develop low-cost, at-home urine tests for BUP, norbuprenorphine (norBUP), a major dealkylated metabolite of BUP using the PGM. By developing test strips that are compatible with existing PGMs, we will take advantage of over 30 years of PGM research and circumvent the costly hardware development process. The recent successful launch of FDA-approved smartphone-enabled PGMs will enable wireless transmission of reminders, test results, and data analysis through smartphone apps. The goal of the Phase I research is to demonstrate the feasibility of using a smartphone attached PGM to: (1) detect BUP and norBUP at 10 ng/mL in buffer solution and urine; (2) develop test strips for BUP and norBUP with a limit of detection of 10 ng/mL in buffer solution; and (3) assess the performance of tests strips in urine samples. Accomplishing these specific aims will pave the way for Phase II research in developing both product prototypes and the smartphone platform. Successful applications of the proposed product will have significant impact on boosting compliance for not only BUP treatment, but also treatment of other SUDs.

描述：物质使用障碍(SUD)是一种主要的健康问题，对医疗保健和社会成本有直接和间接的影响，在美国每年估计超过1810亿美元。阿片类药物是第二大滥用药物，丁丙诺啡(BUP)是治疗阿片类药物依赖的一种有效且安全的药物。然而，BUP仍然是一种麻醉剂，严格遵守BUP对患者获得最佳治疗结果、防止复发和避免药物转移至关重要。通常通过在医院就诊时进行定期和随机的尿检来监测遵从性。然而，由于每次定期尿液药物测试的间隔时间较长，患者的随机药物测试成本较高，而且具有侵入性，这种措施不足以防止BUP被转用于非预期用途。因此，价格低廉、使用方便，并在保护患者隐私的同时向医生提供实时检测结果的随机尿药检测将提高患者的服药依从性。虽然已经开发了许多用于尿液测试和电子监测的方法，但很少有测试技术满足所有上述要求，这可能是因为新的PoC设备的开发和制造成本很高，特别是当这些设备是市场上的新设备时。为了克服这一限制，伊利诺伊大学的陆毅教授的团队报告了一项发现，该发现允许重新使用广泛可用的低成本个人血糖仪(PGM)来检测许多非葡萄糖靶标。创新之处在于将非葡萄糖靶标(如BUP)与其抗体的结合转化为释放能将蔗糖分解为葡萄糖的转化酶，然后用PGM进行定量。通过这一转移奖，我们建议将正在申请专利的发现转化为商业化产品。通过获得技术许可并招募Lu集团的两名关键成员，GLucoSentient公司计划开发用于BUP的低成本家庭尿液测试，去丁丙诺啡(NorBUP)是BUP的一种使用PGM的主要脱烷基代谢物。通过开发与现有PGM兼容的测试条，我们将利用PGM 30多年的研究成果，避免昂贵的硬件开发过程。最近FDA批准的支持智能手机的PGM的成功推出将使提醒、测试结果和数据分析能够通过智能手机应用程序进行无线传输。第一阶段研究的目标是证明使用智能手机连接PGM的可行性：(1)检测缓冲液和尿液中10 ng/毫升的BUP和norBUP；(2)研制BUP和NorBUP的测试试纸，缓冲区溶液中的最低检测限为10 ng/mL；以及(3)评估尿样测试试纸的性能。实现这些具体目标将为开发产品原型和智能手机平台的第二阶段研究铺平道路。建议产品的成功应用不仅将对提高BUP治疗的依从性有重大影响，而且对其他肥皂水的治疗也将产生重大影响。