Stream Dx: Point of Care Cellular Enabled IoT Communication Hub for Improved Diagnosis, Monitoring, and Post-Treatment Evaluation of LUTS

Stream Dx：护理点蜂窝物联网通信中心，用于改进 LUTS 的诊断、监测和治疗后评估

• 批准号: 9909164
• 负责人: James Hotaling
• 金额: $ 99.9万
• 依托单位: STREAM DX, INC.
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-04-03 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9909164
• 关键词: Address; Affect; Aftercare; Age; Age-Years; Aging; American; Area; Bluetooth; Businesses; Characteristics; Child; Chronically Ill; Cities; Clinic; Clinical; Communication; Consumption; Data; Device or Instrument Development; Devices; Diagnosis; Disabled Persons; Early Diagnosis; Evaluation; Event; Flowmeters; Frequencies; Frustration; Future; Generations; Goals; Gold; Grant; Graph; Guidelines; Healthcare Systems; Heart failure; Home environment; Hour; Insurance; Intake; International; Intervention; Legal patent; Liquid substance; Measurement; Measures; Medical; Medical Device; Medication Management; Memory; Mental Depression; Monitor; National Institute of Diabetes and Digestive and Kidney Diseases; Notification; Online Systems; Operative Surgical Procedures; Outcome; Patient Monitoring; Patient Representative; Patient-Focused Outcomes; Patients; Pattern; Performance; Pharmaceutical Preparations; Phase; Physicians; Physiological; Play; Positioning Attribute; Privacy; Privatization; Probability; Process; Progressive Disease; Quality of life; Research; Resolution; Risk; Role; Screening for cancer; Societies; Sodium Chloride; Stream; System; Technology; Test Result; Testing; Time; United States Food and Drug Administration; United States National Institutes of Health; Universities; Urinalysis; Urine; Urodynamics; Urology; Utah; Wireless Technology; Woman; base; care providers; compliance behavior; cost; data integrity; design; diaries; experience; follow-up; improved; innovation; lower urinary tract symptoms; male; men; meter; off-patent; older men; older patient; point of care; public health relevance; rural patients; screening; sensor; treatment planning; urinary; urologic; usability; verification and validation; wireless communication

PROJECT SUMMARY / ABSTRACT - STREAM DX Lower urinary tract symptoms (LUTS) is one of the most common medical problems among older men – affecting 33% of men by the time they reach 50 years of age and 75% by the time they reach the age of 80. LUTS is a progressive disease that has been shown to significantly increase the risk of depression and reduce quality of life. Early detection, intervention and active management is critical to successful treatment of LUTS. Uroflowmetry is an important and ubiquitous test in the diagnosis, monitoring, and post-treatment evaluation of men with LUTS. Uroflowmeters are devices that collect a complete urine void and then generate graphs that characterize the volume and flow rate pattern of the void. From these graphs, physicians should be able to identify the peak urinary flow (Qmax) which is the best single measure to predict whether a patient’s urine stream is obstructed. However, there are serious limitations and inherent pitfalls to uroflowmetry testing done in-clinic. First, having patients void in an artificial and unfamiliar clinic setting resulting in a different flow characteristic compared to having them void at home. Second, in-clinic testing results in a high number of uninterpretable voids when the patient can’t void enough in the unfamiliar setting. Uninterpretable voids are not billable by the care provider and the time spent attempting to collect this data in the clinic is wasted, creating frustration for the patient and the clinicians. Third, disabled, rural and elderly patients often have difficulty in getting to the doctor’s office exacerbating the testing process further. Stream Dx, Inc. has developed a low-cost, clinically accurate electronic flowmeter for at-home use, SDX01. The device is patented, registered with the FDA and has been introduced to the marketplace. It is an early stage uroflowmeter which accurately generates the same volume and flow data that is collected by in-clinic uroflowmeters but can store multiple days’ worth of patient void data in memory. SDX01 collects the data for each void, which is then either uploaded by the patient or Stream Dx to the company’s web-based portal for clinician viewing. The clinician can them immediately address concerns directly with the patient. In this Phase IIb proposal, Stream Dx will significantly improve the product and reduce costs while maintaining clinical accuracy. We expect to improve the device and data by adding fluid consumption as well as collecting additional urine flow data. We will migrate data transfer to a wireless cellular enabled IoT communications hub via Bluetooth 5.0. for real time access to patient data. These are non-irritative improvements and key to assuring patient usability and outcomes, maximize clinician time and patient interactions, ultimately producing the gold standard product. Today, none of the existing devices or apps in this area have a focus on monitoring the relationship of fluid intake to urine outflow, provide patient notifications to improve patient compliance, provide physician alerts or can collect urinalysis or other physiological data in future applications. When this Phase IIb is complete, Stream Dx’s SDX01 will be the gold standard in the monitoring and treatments of LUTS and be integrated into the marketplace across the U.S.

项目摘要/摘要 - STREAM DX 下尿路症状 (LUTS) 是老年男性中最常见的医疗问题之一 - 影响 33% 的男性在 50 岁时出现这种情况，75% 在 80 岁时出现这种情况。 进行性疾病已被证明会显着增加抑郁症的风险并降低生活质量。 早期发现、干预和积极管理对于成功治疗 LUTS 至关重要。尿流率测定是 在男性 LUTS 的诊断、监测和治疗后评估中，这是一项重要且普遍的测试。 尿流量计是收集完整尿液并生成表征尿液特征的图表的设备。 空隙的体积和流速模式。从这些图表中，医生应该能够识别峰值 尿流量（Qmax）是预测患者尿流是否受阻的最佳单一指标。 然而，在诊所进行的尿流率测定存在严重的局限性和固有的缺陷。首先，有 患者在人工且不熟悉的诊所环境中排尿，导致尿流特征与患者不同 让它们在家里无效。其次，临床测试会导致大量无法解释的空洞，当 患者在不熟悉的环境中无法充分排尿。无法解释的空缺不会由护理提供者计费，并且 尝试在诊所收集这些数据的时间被浪费了，给患者和医生带来挫败感 临床医生。第三，残疾人、农村患者和老年患者就医往往存在困难 进一步加剧测试过程。 Stream Dx, Inc. 开发了一种低成本、临床准确的电子 家用流量计，SDX01。该设备已获得专利，已在 FDA 注册并已推出 到市场。它是一款早期尿流量计，可准确生成相同的体积和流量数据 该数据由诊所内尿流量计收集，但可以在内存中存储多天的患者排尿数据。 SDX01 收集每个空位的数据，然后由患者或 Stream Dx 上传到公司的 供临床医生查看的基于网络的门户。临床医生可以立即直接与患者解决问题 病人。在这个 IIb 阶段提案中，Stream Dx 将显着改进产品并降低成本，同时 保持临床准确性。我们希望通过增加液体消耗以及 收集额外的尿流数据。我们将把数据传输迁移到支持无线蜂窝的物联网 通过蓝牙 5.0 的通信集线器。实时访问患者数据。这些都是无刺激性的 改进和确保患者可用性和结果的关键，最大化临床医生的时间和患者 相互作用，最终产生黄金标准产品。今天，这个领域中没有现有的设备或应用程序 区域重点监测液体摄入量与尿液流出量的关系，向患者提供通知 提高患者的依从性，向医生提供警报或可以在将来收集尿液分析或其他生理数据 应用程序。当第二阶段完成后，Stream Dx 的 SDX01 将成为监控领域的黄金标准 LUTS 的治疗和治疗，并融入美国市场