Late stage development and preparation of a long-term non-enzymatic continuous glucose sensor for clinical trials
用于临床试验的长期非酶连续葡萄糖传感器的后期开发和制备
基本信息
- 批准号:9788419
- 负责人:
- 金额:$ 35.68万
- 依托单位:
- 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:2013-09-20 至 2020-07-31
- 项目状态:已结题
- 来源:
- 关键词:AdoptedAdoptionAffectAntioxidantsBody TemperatureBoronic AcidsBusinessesCellsChemistryChronicChronic DiseaseClinical TrialsClinical trial protocol documentComplexCost of IllnessDataDevelopmentDevicesDiabetes MellitusDiseaseDocumentationDyesElectronicsEnsureFamily suidaeFibrosisFilmForeign BodiesFrightGlucoseHealthHealth ExpendituresHealthcare SystemsHumanHydrogelsHydrogen PeroxideHypoglycemiaImmuneImmune responseImplantIndividualInflammationInflammatory ResponseInjectableInstitutional Review BoardsInsulinInvestigationLengthLettersLibrariesLifeMarket ResearchMonitorOperative Surgical ProceduresOpticsPatientsPhasePhysiologicalPlasticsPolymersPrediabetes syndromePreparationProductionPumpQuality of lifeReaderReporterRiskSkinSmall Business Innovation Research GrantSterilitySterilizationSyringesSystemTarget PopulationsTechnologyThinnessTimeTissuesValidationVariantVertebral columnWireless TechnologyWorkauthoritybasebiomaterial compatibilityburden of illnesscapsuleclinical developmentclinical translationcommercializationcostdesigndiabetes managementdiabeticdiabetic patientfirst-in-humanglucose monitorglucose sensorhard metalimplantable deviceimprovedin vivonanosizedpreclinical studyresearch clinical testingresponsescaffoldsensorsensor technologysubcutaneoustoolusabilityverification and validation
项目摘要
Abstract
Diabetes is a complex multi-factorial disease that diminishes the length and quality of life of affected individuals.
The use of continuous glucose monitors (CGM) can be an invaluable management tool for patients afflicted by
this chronic and costly disease. However, despite years of development, currently available continuous glucose
monitors (CGMs) still lack good accuracy and reliability for short-term and particularly, long-term use in diabetes
management. The main obstacles to achieving a long-term, accurate CGM are instabilities in the sensing
chemistry and the body’s immune response against the sensor – specifically the foreign body response (FBR) –
leading to biofouling, inflammation, avascular fibrosis and sensing chemistry degradation. Additionally, current
CGM systems in the market and under development are either bulky percutaneous probes or implantable
devices encased in hard metals or plastics that become surrounded by an avascular tissue capsule over time or
are taken up by immune cells (if nano-sized). Profusa has developed fluorescent, non-enzymatic boronic acid
(BA)-based glucose sensors that are produced in a tissue-integrating hydrogel format that has been shown to
minimize the FBR, enabling long-term monitoring. In this CRP SBIR, we aim to guide our successfully
demonstrated injectable glucose sensors through late stage development and technical activities that are vital
for commercialization. Clinical translation of this technology will motivate and enable diabetic and pre-diabetic
patients to more tightly control their glucose levels without fear of hypoglycemia and will reduce the diabetes
disease burden on the healthcare system. In this project, we propose to prepare the path for first-in-human
clinical testing, as a first step towards commercialization. To this end, we will demonstrate production of sterile,
biocompatible, packaged sensors ready for clinical trial use in order to ensure compliance with regulatory
standards. We will perform market research analysis to determine target population, assess reimbursement
potential, and develop regulatory strategies to align clinical development with business objectives. In addition,
we will complete documentation regarding investigational device exemption. Finally, we will design and plan for
a first-in-human (FIH) clinical trial by preparing all necessary documents for IRB submission. This proposal will
aid Profusa in moving its glucose sensor towards commercialization, to significantly improve the health and
quality of life of pre-diabetic and diabetic patients.
摘要
糖尿病是一种复杂的多因素疾病,会缩短受影响个体的生命长度和质量。
使用连续葡萄糖监测仪(CGM)可以是一个宝贵的管理工具,为患者的痛苦,
这种慢性且昂贵的疾病。然而,尽管经过多年的发展,目前可用的连续葡萄糖
对于糖尿病患者的短期使用,特别是长期使用,
管理实现长期、准确CGM的主要障碍是传感中的不稳定性
化学和身体对传感器的免疫反应-特别是异物反应(FBR)-
导致生物淤积、炎症、无血管纤维化和传感化学降解。此外,当前
市场上和开发中的CGM系统要么是笨重的经皮探头,要么是植入式探头。
用硬金属或塑料包裹的器械,随着时间的推移,被无血管组织囊包围,或
被免疫细胞吸收(如果是纳米级的)。Profusa开发了荧光,非酶硼酸
基于(BA)的葡萄糖传感器,以组织整合水凝胶形式生产,已被证明可以
最大限度地减少FBR,实现长期监测。在这个CRP SBIR中,我们的目标是成功地指导我们的
通过后期开发和技术活动展示了可注射葡萄糖传感器,
用于商业化。这项技术的临床转化将激励和使糖尿病和糖尿病前期
患者更严格地控制他们的血糖水平,而不必担心低血糖,并将减少糖尿病
医疗系统的疾病负担。在这个项目中,我们建议为首次在人类
临床试验,作为迈向商业化的第一步。为此,我们将展示无菌,
可用于临床试验的生物相容性包装传感器,以确保符合法规要求
标准我们将进行市场调查分析,以确定目标人群,评估报销
潜力,并制定监管策略,使临床开发与业务目标保持一致。此外,本发明还提供了一种方法,
我们将完成有关试验用器械豁免的文件。最后,我们将设计和规划
通过准备IRB提交的所有必要文件进行首次人体(FIH)临床试验。这项建议会
帮助Profusa将其葡萄糖传感器推向商业化,以显著改善健康状况,
糖尿病前期和糖尿病患者的生活质量。
项目成果
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