The Biostatistics Research Center for the Impaired Awareness of Hypoglycemia Consortium
The Biostatistics Research Center for the Impaired Awareness of Hypoglycemia Consortium
批准号:
10599379
负责人:
Vernon M Chinchilli
金额:
$82.93万
依托单位国家:
美国
项目类别:
财政年份:
2022
资助国家:
美国
项目状态:
未结题
起止时间:
2022-09-25 至 2027-12-31
关键词:
AccountabilityAdherenceAdultAdverse eventAdvocacyAncillary StudyAwarenessBiological AssayBiological MarkersBiometryBlood GlucoseCaregiversCessation of lifeClinical ResearchClinical TrialsClinical Trials Data Monitoring CommitteesCollectionComaCommunicationConduct Clinical TrialsConflict of InterestDataData AnalysesData Coordinating CenterData Management ResourcesDevelopmentDevicesDiabetes MellitusDigestive System DisordersEnrollmentEnsureEvaluationFamily memberFundingGlucoseGlycosylated hemoglobin AHealth SciencesHealthcare SystemsHeterogeneityHypoglycemiaImpairmentIndividualInstitutesInstitutional Review BoardsInsulin-Dependent Diabetes MellitusInternetInvestigationInvestigational New Drug ApplicationKidney DiseasesLaboratoriesLeadLogisticsManualsManuscriptsMeasuresMedicalMedicineMonitorNational Institute of Diabetes and Digestive and Kidney DiseasesPatient Self-ReportPatientsPennsylvaniaPreparationProceduresProcessProtocols documentationPsychometricsPublic HealthPublicationsQuality ControlQuestionnairesReportingRequest for ApplicationsResearchResearch DesignSafetySafety ManagementSample SizeSecuritySite VisitStatistical Data InterpretationSupport SystemSystemTechnologyTimeUnited States Food and Drug AdministrationUnited States National Institutes of HealthUniversitiesValidationVendorVisitacute pancreatitisbaseclinical centercollegecostdata exchangedata managementdata submissiondesigndrug distributionexperienceglucose monitorimprovedmemberparticipant enrollmentprogramsquality assurancerandomized trialrecruitrepositoryresponserestorationweb site
中文摘要
摘要
1 型糖尿病 (T1D) 患者容易反复发生低血糖,这可能导致
低血糖意识受损(IAH)。因此,IAH 导致人们对 IAH 的认识减少。
对外部葡萄糖的需求以及增加所需的反调节反应的减弱
血糖。对于患有 IAH 的 T1D 患者来说,这可能是一种非常危险的情况,可能会导致昏迷和昏迷。
在某些情况下,死亡。对于患有 IAH 的 T1D 个体来说,这可能是一种非常危险的情况,可能会导致
昏迷,在某些情况下甚至死亡。许多 T1D 研究因混杂因素而排除 IAH 个体
问题。因此,国家糖尿病、消化和肾脏疾病研究所(NIDKK)发布了
两个 RFA 组成 IAH 联盟,该联盟将研究导致异质性的因素
恢复患有 IAH 的成年 T1D 患者对低血糖的认识。 RFA-DK-21-020 和 RFA-DK-21-
036 分别请求临床中心和唯一的生物统计研究中心(BRC)的申请。
IAH 联盟的目标是
• 确定是否使用糖尿病技术来优化 HbA1c 的最新管理策略
同时最大限度地减少低血糖可以恢复低血糖意识并改善反调节
T1D 和 IAH 患者的反应
• 确定范围内的时间强度和持续时间、发生低血糖的时间或其他指标
与低血糖意识恢复相关的连续血糖监测仪
• 确定当前或新制定的IAH 自我报告措施与反措施之间的关联
阐明低血糖意识恢复的异质性的监管反应
宾夕法尼亚州立大学医学院公共卫生科学系提议
担任 IAH 联盟的 BRC,并将实现七个具体目标。
具体目标 1:合作开展和开展研究,并领导统计分析
具体目标 2:领导联盟制定自我报告 IAH 的措施
具体目标 3:建立一个中心实验室
具体目标 4:领导联盟参与利益相关者的参与
具体目标 5:开发数据管理和网站流程
具体目标 6:保持监管合规性
具体目标 7:提供沟通和项目管理支持
英文摘要
ABSTRACT
Individuals with Type 1 Diabetes (T1D) are susceptible to repeated episodes of hypoglycemia, which can result
in impaired awareness of hypoglycemia (IAH). As a consequence, IAH contributes to diminished recognition of
the need for external glucose and the blunting of counter-regulatory responses that are required to increase
blood glucose. This can be a very risky situation for T1D individuals with IAH, possibly leading to coma and in
some circumstances, death. This can be a very risky situation for T1D individuals with IAH, possibly leading to
coma and in some circumstances, death. Many T1D studies exclude IAH individuals because of confounding
issues. Therefore, the National Institute for Diabetes and Digestive and Kidney Diseases (NIDKK) has issued
two RFAs to form the IAH Consortium that will investigate factors which contribute to the heterogeneity of
restoration of awareness of hypoglycemia in adult T1D individuals with IAH. RFA-DK-21-020 and RFA-DK-21-
036 request applications for Clinical Centers and the sole Biostatistics Research Center (BRC), respectively.
The objectives of the IAH Consortium will be to
• determine if the most up-to-date management strategies using diabetes technology to optimize HbA1c
while minimizing hypoglycemia can restore awareness of hypoglycemia and improve counter-regulatory
responses in individuals with T1D and IAH
• identify the magnitude and duration of time in range, time spent in hypoglycemia or other metrics for
continuous glucose monitors that are associated with restoration of awareness of hypoglycemia
• determine the association of current or newly developed self-reported measures of IAH with counter-
regulatory responses to elucidate the heterogeneity in restoration of hypoglycemia awareness
The Department of Public Health Sciences at The Pennsylvania State University College of Medicine proposes
to serve as the BRC for the IAH Consortium, and will pursue seven specific aims.
Specific Aim 1: Collaborate on the development and conduct of studies, and lead statistical analyses
Specific Aim 2: Lead the Consortium in developing measures of self-reported IAH
Specific Aim 3: House a Central Laboratory
Specific Aim 4: Lead the Consortium in stakeholder engagement
Specific Aim 5: Develop data management and website processes
Specific Aim 6: Maintain regulatory compliance
Specific Aim 7: Provide communication and project management support
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会议论文
Data Coordinating Center for the Type 1 Diabetes in Acute Pancreatitis Consortium
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批准号:10907944
-
项目类别:
-
资助金额:$31.8万
-
财政年份:2020
-
负责人:Vernon M Chinchilli
-
依托单位:
Data Coordinating Center for the Type 1 Diabetes in Acute Pancreatitis Consortium
-
批准号:10461052
-
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资助金额:$395.07万
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财政年份:2020
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负责人:Vernon M Chinchilli
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依托单位:
Data Coordinating Center for the Type 1 Diabetes in Acute Pancreatitis Consortium
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批准号:10672905
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项目类别:
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资助金额:$389.57万
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财政年份:2020
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负责人:Vernon M Chinchilli
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Data Coordinating Center for the Type 1 Diabetes in Acute Pancreatitis Consortium
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批准号:10471067
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资助金额:$176.91万
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Data Coordinating Center for the Type 1 Diabetes in Acute Pancreatitis Consortium
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批准号:10265554
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资助金额:$231.63万
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财政年份:2020
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负责人:Vernon M Chinchilli
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依托单位:
Novel statistical methods for controlled variable selection of microbiome data
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批准号:10116262
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资助金额:$22.57万
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财政年份:2020
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负责人:Vernon M Chinchilli
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依托单位:
Ambulatory Methods for Measuring Cognitive Change
-
批准号:10213642
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项目类别:
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资助金额:$59.04万
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财政年份:2018
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负责人:Vernon M Chinchilli
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依托单位:
Ambulatory Methods for Measuring Cognitive Change
-
批准号:10426148
-
项目类别:
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资助金额:$65.57万
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财政年份:2018
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负责人:Vernon M Chinchilli
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依托单位:
Data Coordinating Center for the Natural History of AKI Consortium
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批准号:7687205
-
项目类别:
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资助金额:$19.0万
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财政年份:2008
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负责人:Vernon M Chinchilli
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依托单位:
Data Coordinating Center for the Natural History of AKI Consortium
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批准号:8143961
-
项目类别:
-
资助金额:$20.0万
-
财政年份:2008
-
负责人:Vernon M Chinchilli
-
依托单位:
Data Coordinating Center for the Natural History of AKI Consortium
-
批准号:8909116
-
项目类别:
-
资助金额:$87.0万
-
财政年份:2008
-
负责人:Vernon M Chinchilli
-
依托单位:
Data Coordinating Center for the Natural History of AKI Consortium
-
批准号:8333252
-
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资助金额:$84.0万
-
财政年份:2008
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负责人:Vernon M Chinchilli
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依托单位:
Data Coordinating Center for the Natural History of AKI Consortium
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批准号:8585601
-
项目类别:
-
资助金额:$87.0万
-
财政年份:2008
-
负责人:Vernon M Chinchilli
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依托单位:
Data Coordinating Center for the Natural History of AKI Consortium
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批准号:8733966
-
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资助金额:$36.02万
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财政年份:2008
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负责人:Vernon M Chinchilli
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依托单位:
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批准号:8737229
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项目类别:
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资助金额:$90.76万
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财政年份:2008
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负责人:Vernon M Chinchilli
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依托单位:
Data Coordinating Center for the Natural History of AKI Consortium
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批准号:7810236
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项目类别:
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资助金额:$0.62万
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财政年份:2008
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负责人:Vernon M Chinchilli
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依托单位:
Data Coordinating Center for the Natural History of AKI Consortium
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批准号:7547630
-
项目类别:
-
资助金额:$65.0万
-
财政年份:2008
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负责人:Vernon M Chinchilli
-
依托单位:
Data Coordinating Center for the Natural History of AKI Consortium
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批准号:8333019
-
项目类别:
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资助金额:$9.0万
-
财政年份:2008
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负责人:Vernon M Chinchilli
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依托单位:
Data Coordinating Center for the Natural History of AKI Consortium
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批准号:7912956
-
项目类别:
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资助金额:$84.0万
-
财政年份:2008
-
负责人:Vernon M Chinchilli
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依托单位:
Data Coordinating Center for the Natural History of AKI Consortium
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批准号:8923478
-
项目类别:
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资助金额:$10.0万
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财政年份:2008
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负责人:Vernon M Chinchilli
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依托单位:
海外基金