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Restoration of Impaired Awareness of Hypoglycemia U01 Consortium: University of Kentucky

Award Number: U01DK135111
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/25/2022
PERIOD OF PERFORMANCE END DATE: 12/31/2027

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Restoration of Impaired Awareness of Hypoglycemia U01 Consortium: University of Kentucky - “Restoration of Impaired Awareness of Hypoglycemia U01 Consortium: University of Kentucky” Abstract For insulin-treated people with Type 1 Diabetes (T1D), hypoglycemia is the rate limiting step in their goals to appropriately control their blood sugar and avoid long-term diabetes complications. Unfortunately, repeated episodes of hypoglycemia have been shown to induce a pathological process leading to impaired awareness of hypoglycemia (IAH) and an impaired counterregulatory response hypoglycemia that increases the risk for life-threatening hypoglycemia. This grant application (in response to RFA-DK-21-020) seeks to establish a 10- site clinical consortium to determine the factors that contribute to the heterogeneity in the restoration of IAH and improved counterregulatory responses in adult individuals with T1D. It is proposed to test the hypothesis that a combination of, 1) advanced diabetes care technology comprised of a hybrid closed loop insulin pump with continuous glucose monitor (CGM), coupled with 2) intensive hypoglycemia avoidance education, will lead to a decrease in the frequency/severity of hypoglycemia and thereby improve the awareness of hypoglycemia and improve the counterregulatory response. The specific aims of this proposal, as outlined in the RFA, are; 1) determine if diabetes care with use of the most up-to-date management strategies (i.e. a hybrid closed loop system and hypoglycemia avoidance education) which optimizes HbA1c while minimizing hypoglycemia can restore awareness of hypoglycemia in individuals with T1D and IAH, 2) determine the physiological factors that are associated with restoration of hypoglycemia awareness and counterregulatory response, including but not limited to age, duration of diabetes and metrics of glycemia (eg, time in range, time spent in hypoglycemia or other CGM metrics), and 3) determine the association of the current self-report questionnaires (or develop new metrics) for identification of IAH with measurement of CRR using state of the art metabolic assessments, i.e. hypoglycemic, hyperinsulinemic clamps. The University of Kentucky is well-poised to contribute to this valuable consortium effort because 1) the University has the requisite institutional infrastructure to support all aspects of this research, 2) this proposal outlines several novel approaches to measure and analyze hypoglycemia awareness, 3) the PI has assembled an experienced leadership team has the requisite expertise in T1D subject recruitment and conducting hypoglycemia awareness studies, and importantly, 4) this site will provide the NIDDK with access to unique pool of US-based, often understudied, rural study subjects with T1D.


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: 2026 ( Subtotal = $790,957 )
2026	2026	UNIVERSITY OF KENTUCKY RESEARCH FOUNDATION, THE	500 S LIMESTONE	LEXINGTON	KY	40526	FAYETTE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	2/2/2026	NON-COMPETING CONTINUATION	$790,957
														Subtotal = $790,957

Issue Date FY: 2025 ( Subtotal = $530,098 )
2025	2025	UNIVERSITY OF KENTUCKY RESEARCH FOUNDATION, THE	500 S LIMESTONE	LEXINGTON	KY	40526	FAYETTE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	3	4/10/2025	NON-COMPETING CONTINUATION	$530,098
2025	2024	UNIVERSITY OF KENTUCKY RESEARCH FOUNDATION, THE	500 S LIMESTONE	LEXINGTON	KY	40526	FAYETTE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	12/11/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $530,098

Issue Date FY: 2024 ( Subtotal = $654,502 )
2024	2024	UNIVERSITY OF KENTUCKY RESEARCH FOUNDATION, THE	500 S LIMESTONE	LEXINGTON	KY	40526	FAYETTE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	4/18/2024	NON-COMPETING CONTINUATION	$654,502
														Subtotal = $654,502

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2022	UNIVERSITY OF KENTUCKY RESEARCH FOUNDATION, THE	500 S LIMESTONE 109 KINKEAD HALL	LEXINGTON	KY	40526	FAYETTE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	6/27/2023	NEW	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $374,425 )
2022	2022	UNIVERSITY OF KENTUCKY RESEARCH FOUNDATION, THE	500 S LIMESTONE 109 KINKEAD HALL	LEXINGTON	KY	40526	FAYETTE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	9/21/2022	NEW	$374,425
														Subtotal = $374,425

Grand Total All Awards = $2,349,982

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Restoration of Impaired Awareness of Hypoglycemia U01 Consortium: University of Kentucky

Award Number: U01DK135111

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/25/2022

PERIOD OF PERFORMANCE END DATE: 12/31/2027

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