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The Biostatistics Research Center for the Impaired Awareness of Hypoglycemia Consortium

Award Number: U01DK135126
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 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


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: 2024 ( Subtotal = $2,361,429 )
2024	2024	PENNSYLVANIA STATE UNIVERSITY	500 UNIVERSITY DRIVE	HERSHEY	PA	17033	DAUPHIN	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	4/10/2024	NON-COMPETING CONTINUATION	$2,361,429
														Subtotal = $2,361,429

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2022	PENNSYLVANIA STATE UNIVERSITY	500 UNIVERSITY DRIVE	HERSHEY	PA	17033	DAUPHIN	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	6/27/2023	NEW	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $829,347 )
2022	2022	PENNSYLVANIA STATE UNIVERSITY, THE	500 UNIVERSITY AVE RM C1607	HERSHEY	PA	17033	DAUPHIN	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	9/23/2022	NEW	$829,347
														Subtotal = $829,347

Grand Total All Awards = $3,190,776

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The Biostatistics Research Center for the Impaired Awareness of Hypoglycemia Consortium

Award Number: U01DK135126

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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