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Data Coordinating Center for the Type 1 Diabetes in Acute Pancreatitis Consortium

Award Number: U01DK127384
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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ABSTRACT Type 1 diabetes mellitus (T1D) may develop after, or as a consequence of, one or more acute pancreatitis episodes. Elucidation of early biomarkers, clinical signs, biomarkers of disease progression, immune and genetic risk factors, most susceptible subgroups, precipitating mechanisms, etiology of acute pancreatitis, and associated pathophysiology of the T1D can help inform best practices in treatment for reducing incidence of T1D onset. In response to the National Institute of Diabetes and Digestive and Kidney Diseases’ RFA-DK-19- 023, the Departments of Public Health Sciences (DPHS) and Medicine (Endocrinology and Gastroenterology) at The Pennsylvania State University College of Medicine and the Allegheny Health Network propose to serve as the Data Coordinating Center (DCC) for the Type 1 Diabetes in Acute Pancreatitis Consortium (T1DAPC). One DCC and 10 Clinical Centers (RFA-DK-19-022) will form the clinical consortium, T1DAPC. An efficient and supportive DCC not only collaborates on development of all documentation and provides efficient statistical analyses and Trial Master File, the results from the DCC form the backbone of numerous publications, preliminary data for subsequent trials, and may lead to profound novel insights from ad-hoc, post-hoc, and newly formulated analyses to Questions arising during the study. DPHS has vast experience and expertise as the DCC for 10 NIH-funded clinical trial and five observational study research networks, which resulted in more than 200 publications, six subsequent grants. Our vast experience in DCC for HIPAA-compliant data compilation and analyses of multicenter clinical trials spans more than a dozen therapeutic areas and can provide additional insights for analysis of ethnically and geographically diverse population of subjects as well as development and analyses of distinct and overlapping clinical profiles, some being instituted post hoc with development and testing cohorts. The DCC will aggregate and analyze all common data elements and samples and provide scientific infrastructure and administrative support in a clear, concise, friendly manner for the T1DAPC Consortium. The DCC and the Clinical Centers will form multi-disciplinary teams that execute a prospective longitudinal observational study that can determine the incidence of T1 diabetes associated with an acute pancreatitis episode and assess relationships with potential early biomarkers, clinical signs, biomarkers of disease progression, immune and genetic risk factors, most susceptible subgroups, precipitating mechanisms, etiology of acute pancreatitis, and associated pathophysiology of the T1D or other types of diabetes. The DCC will collect, synthesize, and disseminate main findings and lessons learned from the T1DAPC parent and ancillary studies, create public data sets, and share the biological samples in accordance with the NIDDK and T1DAPC.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2023 ( Subtotal = $4,213,656 )
2023	2023	PENNSYLVANIA STATE UNIVERSITY	500 UNIVERSITY DRIVE	HERSHEY	PA	17033	DAUPHIN	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	4	9/1/2023	SUPPLEMENT FOR EXPANSION	$318,006
2023	2023	PENNSYLVANIA STATE UNIVERSITY	500 UNIVERSITY DRIVE	HERSHEY	PA	17033	DAUPHIN	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	4	8/2/2023	NON-COMPETING CONTINUATION	$3,895,650
2023	2022	PENNSYLVANIA STATE UNIVERSITY	500 UNIVERSITY DRIVE	HERSHEY	PA	17033	DAUPHIN	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	5/30/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $4,213,656

Issue Date FY: 2022 ( Subtotal = $5,719,816 )
2022	2022	PENNSYLVANIA STATE UNIVERSITY, THE	500 UNIVERSITY AVE RM C1607	HERSHEY	PA	17033	DAUPHIN	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	003	3	7/28/2022	NON-COMPETING CONTINUATION	$3,950,734
2022	2022	PENNSYLVANIA STATE UNIVERSITY, THE	500 UNIVERSITY AVE RM C1607	HERSHEY	PA	17033	DAUPHIN	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	2	5/16/2022	SUPPLEMENT FOR EXPANSION	$1,769,082
2022	2021	PENNSYLVANIA STATE UNIVERSITY, THE	500 UNIVERSITY AVE RM C1607	HERSHEY	PA	17033	DAUPHIN	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	10/15/2021	NON-COMPETING CONTINUATION	$0
2022	2021	PENNSYLVANIA STATE UNIVERSITY, THE	500 UNIVERSITY AVE RM C1607	HERSHEY	PA	17033	DAUPHIN	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	2	12/20/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $5,719,816

Issue Date FY: 2021 ( Subtotal = $2,316,295 )
2021	2021	PENNSYLVANIA STATE UNIVERSITY, THE	500 UNIVERSITY AVE RM C1607	HERSHEY	PA	17033	DAUPHIN	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	8/3/2021	NON-COMPETING CONTINUATION	$2,316,295
														Subtotal = $2,316,295

Issue Date FY: 2020 ( Subtotal = $2,322,833 )
2020	2020	PENNSYLVANIA STATE UNIVERSITY, THE	500 UNIVERSITY DR C1607	HERSHEY	PA	17033	DAUPHIN	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	9/17/2020	NEW	$2,322,833
														Subtotal = $2,322,833

Grand Total All Awards = $14,572,600

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Data Coordinating Center for the Type 1 Diabetes in Acute Pancreatitis Consortium

Award Number: U01DK127384

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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