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University of Minnesota Clinical Center for the Restoration of Impaired Awareness of Hypoglycemia in Type 1 Diabetes

Award Number: U01DK135130
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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University of Minnesota Clinical Center for the Restoration of Impaired Awareness of Hypoglycemia in Type 1 Diabetes - Hypoglycemia (HG) is common in the lives of people with type 1 diabetes (T1D) and may prevent them from achieving the benefits associated with optimal glycemic control. Recurrent HG over a few days to weeks may lead to the condition of impaired awareness of HG (IAH) where the first sign of a low blood sugar is confusion or unconsciousness. Avoiding HG is associated with a reduced risk of IAH and when strictly done, may restore HG in some but not all patients with IAH. The reason for this heterogeneity in response remains uncertain.The purpose of this application is to apply to become part of a consortium that will implement a protocol designed to restore awareness of HG in persons with T1D and IAH. As instructed by the FOA, we address the following objectives in our application: 1. Determine if diabetes care with use of the most up-to-date management strategies with T1D and IAH. 2. Determine the physiological factors that are associated with restoration of HG awareness, including but not limited to age, duration of diabetes and metrics of glycemia. 3. Determine the association of the current self-report questionnaires (or develop new questionnaires or metrics) for identification of IAH with measurement of CRR using state of the art metabolic assessments. To meet objective 1, we propose the consortium enroll 650 subjects with T1D and IAH into a randomized clinical trial where a 12-month intervention of HG avoidance education and use of a hybrid closed loop system for insulin infusion is compared to standard care (which includes HG avoidance education, insulin administration via regular pump or injections, and CGM usage). With epinephrine response during the hypoglycemic clamp at 12 months as our primary outcome variable, we will test the hypothesis that subjects in the closed loop intervention arm will have a greater epinephrine response during the hypoglycemic clamp at 12 months of follow- up than will subjects in the control arm. To meet objective 2, we will collect information about glycemic variability, food quality and quantity, physical activity, sleep, stress, mood, and feelings about HG as well as patient characteristics such as HG induced glucagon secretion, residual C-peptide secretion, and diabetes duration. This information will then be explored using machine learning techniques to see what exposures and experiences correlate with IAH restoration. To meet objective three, we will compare the concordance of the Clarke, Gold, and Hypo-AQ questionnaires at categorizing subjects into IAH and NAH groups. The scores on each of the questionnaires will also be correlated with objective measures of the counterregulatory response.


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 = $826,620 )
2026	2026	REGENTS OF THE UNIVERSITY OF MINNESOTA	2221 UNIVERSITY AVE SE STE 100	MINNEAPOLIS	MN	55414	HENNEPIN	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	2/2/2026	NON-COMPETING CONTINUATION	$826,620
														Subtotal = $826,620

Issue Date FY: 2025 ( Subtotal = $997,197 )
2025	2025	REGENTS OF THE UNIVERSITY OF MINNESOTA	2221 UNIVERSITY AVE SE STE 100	MINNEAPOLIS	MN	55414	HENNEPIN	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	3	4/10/2025	NON-COMPETING CONTINUATION	$997,197
2025	2024	REGENTS OF THE UNIVERSITY OF MINNESOTA	200 OAK ST SE	MINNEAPOLIS	MN	55455	HENNEPIN	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	12/11/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $997,197

Issue Date FY: 2024 ( Subtotal = $864,900 )
2024	2024	REGENTS OF THE UNIVERSITY OF MINNESOTA	200 OAK ST SE	MINNEAPOLIS	MN	55455	HENNEPIN	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	4/18/2024	NON-COMPETING CONTINUATION	$864,900
														Subtotal = $864,900

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2022	REGENTS OF THE UNIVERSITY OF MINNESOTA	200 OAK ST SE # 224	MINNEAPOLIS	MN	55455	HENNEPIN	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	6/23/2023	NEW	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $387,494 )
2022	2022	REGENTS OF THE UNIVERSITY OF MINNESOTA	200 OAK ST SE # 224	MINNEAPOLIS	MN	55455	HENNEPIN	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	9/21/2022	NEW	$387,494
														Subtotal = $387,494

Grand Total All Awards = $3,076,211

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University of Minnesota Clinical Center for the Restoration of Impaired Awareness of Hypoglycemia in Type 1 Diabetes

Award Number: U01DK135130

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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