Home Monitoring of Metabolic Disorders
Home Monitoring of Metabolic Disorders
批准号:
10699781
负责人:
Marylaura Lind Thomas
金额:
$54.21万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2023
资助国家:
美国
项目状态:
未结题
起止时间:
2023-09-25 至 2026-08-31
关键词:
AcuteAgeAmmoniaBehaviorBlindedBloodCaregiversCessation of lifeChronicClinicalClinical TrialsCognitionConsensusDataData AnalysesDatabasesDevelopmentDevicesDietDiseaseDropsEmergency department visitEnsureEventFastingFoundationsFrequenciesFundingFutureGeneticGoalsHealthHealth SciencesHereditary DiseaseHomeHome environmentHyperammonemiaImpaired cognitionIndividualInstitutional Review BoardsIntellectual functioning disabilityInterventionKnowledgeLaboratoriesManuscriptsMarketingMeasurementMeasuresMedicalMedical RecordsMedical emergencyMetabolicMetabolic DiseasesMetabolismMonitorMorbidity - disease rateNeurologicNeurologic DysfunctionsNeurologic SymptomsOregonOutcomeParticipantPatient CarePatient RecruitmentsPatientsPerformancePersonsPharmaceutical PreparationsPhysiciansPhysiologyPlasmaPopulationPreventionPreventive measureRecommendationResearchRiskSafetyScienceSignal TransductionSmall Business Innovation Research GrantSurveysSymptomsTarget PopulationsTestingThinkingTimeUnited States Food and Drug AdministrationUnited States National Institutes of HealthUniversitiesUrea cycle disordersWorkclinically relevantcohortcommercializationdisabilityeffective therapyexperiencefatty acid oxidationhealth equityhigh riskimprovedinnovationinnovative technologiesinterestmedical attentionmeetingsmembermetermortalityparticipant enrollmentpatient populationpoint of carepreventreal time monitoringrecruitresponsetime use
中文摘要
项目摘要
本提案是对NOT-HD-22-009特别关注通知(NOSI)的直接响应:创新
技术,以改善评估,干预,和个人与智力和
发育障碍[IDD](R43/R44)。患有某些代谢紊乱的所有年龄段的人都有
当某种代谢物积累时,代谢危机,而这种代谢物可以在临床上测量。
在实验室中,目前没有基于家庭的设备来监测导致代谢危机的代谢物。
我们团队的长期目标是降低与代谢相关的代谢危机的发病率和死亡率。
一定的代谢积累。通过以前和正在进行的国家科学基金会和国家
卫生研究院小企业创新研究基金,我们已经开发了一种家用设备,
准确地测量这种代谢物从一滴血,并正在努力争取FDA的批准。整体
本提案的目的是研究每日在家监测目标代谢物的影响
使用我们开发的设备。这将是第一次在家里测量代谢物,
在家中的目标人群中测量。
我们的中心假设是,当参与者在家中,空腹,早晨测量代谢物水平时,
代谢物结果升高与患者进一步服用
采取行动联系其医疗团队,以进一步监测或采取措施降低代谢物水平。
我们的具体目标是:1)在10名患有疾病的参与者中进行临床试验,
代谢物水平升高,2)分析收集的大量数据,3)准备
结果为了完成我们的方法,我们将从俄勒冈州的现有患者人群中招募患者
健康与科学大学我们将从受试者的病历、观察结果中收集大量数据,
以及装置每日代谢物测量。
这项研究具有创新性,因为它首次提供了一种简单的家庭设备
用于目标代谢物的测量。在这个项目结束时,我们希望了解更多的
家庭代谢物监测对患者护理的影响。
英文摘要
PROJECT SUMMARY
This proposal is submitted in direct response to NOT-HD-22-009 Notice of Special Interest (NOSI): Innovative
Technologies to Improve Assessments, Interventions, and Outcomes for Individuals with Intellectual and
Developmental Disabilities [IDD] (R43/R44). Persons of all ages with certain metabolic disorders are at-risk for
metabolic crises when a certain metabolite accumulates, while this metabolite can be measured in a clinical
laboratory, currently there is no home-based device to monitor the metabolie that causes the metabolic crises.
Our team’s long-term goal is to reduce the morbidity and mortality of metabolic crises associated with
certain metabolic accumulation. Through previous and ongoing National Science Foundation and National
Institutes of Health Small Business Innovation Research funding, we have developed an at-home device to
accurately measure this metabolite from a drop of blood and are working towards FDA clearance. The overall
objective of this proposal is to investigate the impact of daily home-based monitoring of the target metabolite
using the device we developed. This will be the first time that at-home measurement of the metabolite will be
measured in the target population at home.
Our central hypothesis is that when participants measure at-home, fasting, morning metabolite levels
there will be an association between getting an elevated metabolite result and then the patient taking further
action to contacting their medical team to further monitor or take steps to reduce the metabolite level.
Our specific aims are 1) to perform a clinical trial in 10 participants with disorders resulting in risk of
elevated metabolite levels, 2) to analyze the extensive data collected, and 3) to prepare a manuscript of the
results. To complete our approach we will recruit patients from the available patient population at Oregon
Health & Science University. We will collect extensive data from the participant medical record, observations,
and the device daily metabolite measurements.
This research is innovative because, for the first time, it provides a straightforward, home-based device
for measurement of the target metabolite. At the conclusion of this project, we expect to understand more the
impact of home-based metabolite monitoring on patient care.
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Whole Blood Point of Care Metabolic Measurement
-
批准号:10385505
-
项目类别:
-
资助金额:$63.78万
-
财政年份:2021
-
负责人:Marylaura Lind Thomas
-
依托单位:
Whole Blood Point of Care Metabolic Measurement
-
批准号:10618091
-
项目类别:
-
资助金额:$19.63万
-
财政年份:2021
-
负责人:Marylaura Lind Thomas
-
依托单位:
Whole Blood Point of Care Metabolic Measurement
-
批准号:10490896
-
项目类别:
-
资助金额:$63.37万
-
财政年份:2021
-
负责人:Marylaura Lind Thomas
-
依托单位:
Whole Blood Point of Care Metabolic Measurement
-
批准号:10909646
-
项目类别:
-
资助金额:$19.63万
-
财政年份:2021
-
负责人:Marylaura Lind Thomas
-
依托单位:
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