Official websites use .gov

A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS

A lock ( 🔒 ) or https:// means you've safely connected to the .gov website. Share sensitive information only on official, secure websites.

Need Help

Using technology to define and mitigate risk of impaired awareness of hypoglycemia in patients with type 1 diabetes

Award Number: U01DK135121
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

Group Awards By:

View Award Description

Using technology to define and mitigate risk of impaired awareness of hypoglycemia in patients with type 1 diabetes - PROJECT SUMMARY/ ABSTRACT Severe hypoglycemia remains a common and life-threatening issue for patients living with type 1 diabetes (T1D). Research has consistently shown that patients with impaired awareness of hypoglycemia (IAH), which typically coexists with a diminished counterregulatory response (CRR), are at the highest risk for severe hypoglycemia. However, we currently do not have clinically available tools to identify patients with IAH, and even if identified, we lack interventions to reduce their risk. The ultimate goal of this research is to address these large, unmet needs. Specifically, we plan to utilize continuous glucose monitoring (CGM) to identify which CGM metrics are associated with IAH and a diminished CRR (AIM 1). We will then determine if modern T1D management with hybrid closed loop (HCL) systems can restore hypoglycemia awareness (AIM 2). AIM 1: Identify the CGM metrics associated with hypoglycemia awareness Our first hypothesis is that time below range (TBR) by CGM will inversely correlate with epinephrine AUC during a hypoglycemic clamp. This hypothesis is strongly supported by our preliminary data detailed in our research strategy. To test this hypothesis, we propose that the consortium enroll a total of 112 subjects with T1D. Subjects will wear a blinded CGM for 10 days prior to a hypoglycemic clamp. Data to be collected will include counterregulatory hormones during hypoglycemia, hypoglycemia symptom scores (Edinburgh), and hypoglycemic awareness questionnaires (Clarke, Gold, Pederson, and hypo A-Q) as we have previously done. CGM metrics will be correlated with CRR, symptom scores, and currently used questionnaires to define awareness. The study design will determine which CGM metrics predict hypoglycemia awareness and CRR. AIM 2: Determine if hypoglycemia awareness can be restored in individuals with T1D using up-to-date management of diabetes Our second hypothesis is that reducing TBR using modern diabetes management with HCL systems will improve awareness of hypoglycemia and the CRR. To test this hypothesis, all 112 subjects will be randomized 1:1 to either a control arm or a hypoglycemia reduction arm for 2 years. In the control arm, all insulin delivery methods will be allowed and CGM targets will follow current standards of care that allow up to 4% TBR (~1 hour/day). The hypoglycemia avoidance arm will provide all patients with a HCL system and target <1% TBR. Hypoglycemic clamps will be conducted at baseline and months 3, 6, 12, 18, and 24 with 10 days of blinded CGM prior to each clamp. The primary outcome will be the difference in epinephrine AUC during hypoglycemic clamp between study arms. This study design will determine if up-to-date T1D management can restore the CRR and hypoglycemia awareness.


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 = $879,491 )
2026	2026	UNIVERSITY OF CALIFORNIA, SAN DIEGO	9500 GILMAN DR	LA JOLLA	CA	92093	SAN DIEGO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	3/5/2026	NON-COMPETING CONTINUATION	$879,491
														Subtotal = $879,491

Issue Date FY: 2025 ( Subtotal = $633,053 )
2025	2025	UNIVERSITY OF CALIFORNIA, SAN DIEGO	9500 GILMAN DR	LA JOLLA	CA	92093	SAN DIEGO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	3	4/10/2025	NON-COMPETING CONTINUATION	$633,053
2025	2024	UNIVERSITY OF CALIFORNIA, SAN DIEGO	9500 GILMAN DR	LA JOLLA	CA	92093	SAN DIEGO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	12/11/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $633,053

Issue Date FY: 2024 ( Subtotal = $858,003 )
2024	2024	UNIVERSITY OF CALIFORNIA, SAN DIEGO	9500 GILMAN DR	LA JOLLA	CA	92093	SAN DIEGO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	4/19/2024	NON-COMPETING CONTINUATION	$858,003
														Subtotal = $858,003

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2022	UNIVERSITY OF CALIFORNIA, SAN DIEGO	9500 GILMAN DRIVE	LA JOLLA	CA	92093	SAN DIEGO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	6/23/2023	NEW	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $325,987 )
2022	2022	UNIVERSITY OF CALIFORNIA, SAN DIEGO	9500 GILMAN DR	LA JOLLA	CA	92093	SAN DIEGO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	9/21/2022	NEW	$325,987
														Subtotal = $325,987

Grand Total All Awards = $2,696,534

Top

All Categories

About

Search

Reports

Data Submission

Award Information

Using technology to define and mitigate risk of impaired awareness of hypoglycemia in patients with type 1 diabetes

Award Number: U01DK135121

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

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer