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Advanced Insulin Delivery to Reduce Impaired Awareness of Hypoglycemia in a T1D Cohort (AIDRIAHT1C)

Award Number: U01DK135131
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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Advanced Insulin Delivery to Reduce Impaired Awareness of Hypoglycemia in a T1D Cohort (AIDRIAHT1C) - Project Summary/Abstract Intensive insulin treatment decreases the risk of micro- and macrovascular complications in type 1 diabetes (T1D) but is associated with a higher risk of severe hypoglycemia, limiting optimal glycemic control. Over time, 20-30% of patients with T1D develop impaired awareness of hypoglycemia (IAH), most likely as a consequence of repeated and severe episodes of hypoglycemia. IAH is, itself, a significant risk factor for subsequent episodes of severe hypoglycemia, leading to a vicious cycle with potentially lethal consequences. IAH is associated with diminished counter-regulatory responses (CRR) to hypoglycemia and changes in brain structure and function. Reducing the frequency of hypoglycemia with advanced technologies (continuous glucose monitoring [CGM] and insulin pumps) and targeted education improves IAH, but not completely. The Advanced Insulin Delivery to Reduce Impaired Awareness of Hypoglycemia in a Type 1 Diabetes Cohort (AIDRIAHT1C) trial aims at testing the efficacy of HCL compared to sensor-augmented pump (SAP) therapy to improve awareness of hypoglycemia and CRR by reducing the amount of time spent in hypoglycemia. The study will enroll a diverse population of adults with T1D of at least ten years duration. Participants will be classified as having IAH using the HYPO score. Individuals with IAH will be randomized 1:1 to the two interventions and both groups will receive a targeted educational program designed to decrease hypoglycemia. At baseline and at 6-month intervals for 2 years, participants will undergo step-wise hyperinsulinemic- hypoglycemic clamps. The primary outcome, assessed at 12 months, consists of the co-primary endpoints of CRR to hypoglycemia (endogenous glucose production, pancreatic polypeptide, and epinephrine, tested hierarchically) and symptom recognition (autonomic symptom score, HYPO score, also tested hierarchically) (Aim 1). Factors associated with IAH and the restoration of hypoglycemia awareness will be determined from the screened population and the participants in the trial (Aim 2). A matched control group of healthy non- diabetic controls and of participants with T1D and normal awareness of hypoglycemia will be enrolled to provide normative responses to hypoglycemia at baseline. The study also aims at developing new approaches to diagnosing IAH by testing combinations of self-reported items, CGM-prompted reporting, and physiological monitoring, and predicting responses to intervention using machine learning and artificial intelligence (Aim 3) and at studying brain structure and function associated with and predictive of IAH improvement (Aim 4) using fMRI, with and without hypoglycemia. The ultimate goals of the study are to identify the best treatment for IAH, develop better ways to identify individuals at risk, understand the mechanisms of IAH and, ultimately, to reduce the burden and risks associated with severe hypoglycemia and improve quality of life and treatment satisfaction in patients 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 = $740,881 )
2026	2026	ADVENTIST HEALTH SYSTEM/SUNBELT INC	601 E ROLLINS ST	ORLANDO	FL	32803	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	2/2/2026	NON-COMPETING CONTINUATION	$740,881
														Subtotal = $740,881

Issue Date FY: 2025 ( Subtotal = $328,315 )
2025	2025	ADVENTIST HEALTH SYSTEM/SUNBELT INC	601 E ROLLINS ST	ORLANDO	FL	32803	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	3	4/10/2025	NON-COMPETING CONTINUATION	$328,315
2025	2024	ADVENTIST HEALTH SYSTEM/SUNBELT INC	601 E ROLLINS ST	ORLANDO	FL	32803	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	12/11/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $328,315

Issue Date FY: 2024 ( Subtotal = $850,910 )
2024	2024	ADVENTIST HEALTH SYSTEM/SUNBELT INC	601 E ROLLINS ST	ORLANDO	FL	32803	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	4/18/2024	NON-COMPETING CONTINUATION	$850,910
														Subtotal = $850,910

Issue Date FY: 2023 ( Subtotal = -$14,794 )
2023	2022	ADVENTIST HEALTH SYSTEM/SUNBELT, INC.	601 E ROLLINS ST	ORLANDO	FL	32803	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	1	6/23/2023	NEW	$0
2023	2022	ADVENTIST HEALTH SYSTEM/SUNBELT, INC.	601 E ROLLINS ST	ORLANDO	FL	32803	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	2/7/2023	NEW	-$14,794
														Subtotal = -$14,794

Issue Date FY: 2022 ( Subtotal = $409,121 )
2022	2022	ADVENTIST HEALTH SYSTEM/SUNBELT, INC.	601 E ROLLINS ST	ORLANDO	FL	32803	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	9/21/2022	NEW	$409,121
														Subtotal = $409,121

Grand Total All Awards = $2,314,433

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Advanced Insulin Delivery to Reduce Impaired Awareness of Hypoglycemia in a T1D Cohort (AIDRIAHT1C)

Award Number: U01DK135131

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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