Tuesday, August 19, 2025 8/19/2025

Robust Statistical Methods to Identify and Use Surrogate Markers in Diabetes

Award Number: R01DK118354
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/15/2018
PERIOD OF PERFORMANCE END DATE: 06/30/2026

Group Awards By:

View Award Description

Robust Statistical Methods to Identify and Use Surrogate Markers in Diabetes - One in 10 Americans is living with diabetes, a chronic disease that occurs when the pancreas is no longer able to make insulin, or when the body cannot make good use of the insulin it produces. Diabetes impacts an individual’s quality of life, decreases their life expectancy, and increases their risk of heart disease, stroke, kidney failure, and dementia. These consequences of diabetes highlight the importance of identifying effective strategies for prevention of diabetes, and treatment and management of diabetes after diagnosis. In studies that aim to formally test such interventions, it is often the case that long term follow-up of patients is needed in order to observe the primary outcome. The identification and use of surrogate markers in such intervention studies have the potential to support more timely decision-making about the intervention’s effectiveness. While incredible progress has been made in the development of statistical methods to identify surrogate markers, existing methods for evaluating surrogate markers and appropriately using surrogate markers to test for a treatment effect in a future study still face key challenges. Importantly, there are no robust methods to identify when a surrogate may be useful for only certain subgroups of patients, where such subgroups are defined by multiple patient characteristics. Existing methods are limited to a single patient characteristic, but in practice, heterogeneity of a surrogate is more complex and is likely a function of multiple covariates. For example, the surrogacy of changes in hormone levels likely varies by not just sex but also age and body mass index. The impact of such complex heterogeneity is especially important to understand with respect to its potential to lead to violations of surrogacy assumptions that existing methods commonly require to ensure that future testing on the surrogate would accurately reflect testing on the primary outcome. When such testing is not in alignment, termed a surrogate paradox, incorrect conclusions about a treatment may be made. In this study, we aim to develop and apply robust statistical methods to address these challenges. Our methods, software, and results have the potential to inform and improve the design and analysis of future studies aimed at diabetes prevention by identifying when and how a surrogate marker can be used in future studies.


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: 2025 ( Subtotal = $329,222 )
2025	2025	UNIVERSITY OF TEXAS AT AUSTIN	110 INNER CAMPUS DR	AUSTIN	TX	78712	TRAVIS	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	7	7/21/2025	NON-COMPETING CONTINUATION	$329,222
														Subtotal = $329,222

Issue Date FY: 2024 ( Subtotal = $344,090 )
2024	2024	UNIVERSITY OF TEXAS AT AUSTIN	110 INNER CAMPUS DR	AUSTIN	TX	78712	TRAVIS	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	6	8/28/2024	COMPETING CONTINUATION	$359,307
2024	2021	UNIVERSITY OF TEXAS AT AUSTIN	110 INNER CAMPUS DR	AUSTIN	TX	78712	TRAVIS	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	1/26/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	-$15,217
														Subtotal = $344,090

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2021	THE RAND CORPORATION	1776 MAIN ST	SANTA MONICA	CA	90401	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	5/12/2023	NON-COMPETING CONTINUATION	$50
2023	2021	UNIVERSITY OF TEXAS AT AUSTIN	110 INNER CAMPUS DR	AUSTIN	TX	78712	TRAVIS	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	5	5/12/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	-$50
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = -$47,833 )
2022	2021	UNIVERSITY OF TEXAS AT AUSTIN	110 INNER CAMPUS DR	AUSTIN	TX	78712	TRAVIS	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	5	5/20/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$173,728
2022	2021	RAND CORP	1776 MAIN ST	SANTA MONICA	CA	90401	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	003	4	6/27/2022	NON-COMPETING CONTINUATION	-$116,205
2022	2021	UNIVERSITY OF TEXAS AT AUSTIN	110 INNER CAMPUS DR	AUSTIN	TX	78712	TRAVIS	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	004	5	6/27/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$147,207
2022	2021	RAND CORPORATION, THE	1776 MAIN ST	SANTA MONICA	CA	90401	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	5/19/2022	NON-COMPETING CONTINUATION	-$221,561
2022	2020	RAND CORP	1776 MAIN ST	SANTA MONICA	CA	90401	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	3	6/27/2022	NON-COMPETING CONTINUATION	-$31,002
														Subtotal = -$47,833

Issue Date FY: 2021 ( Subtotal = $337,766 )
2021	2021	RAND CORPORATION, THE	1776 MAIN ST	SANTA MONICA	CA	90401	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	6/25/2021	NON-COMPETING CONTINUATION	$337,766
														Subtotal = $337,766

Issue Date FY: 2020 ( Subtotal = $342,256 )
2020	2020	RAND CORPORATION, THE	1776 MAIN ST	SANTA MONICA	CA	90401	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	6/29/2020	NON-COMPETING CONTINUATION	$342,256
														Subtotal = $342,256

Issue Date FY: 2019 ( Subtotal = $335,972 )
2019	2019	RAND CORPORATION, THE	1776 MAIN ST	SANTA MONICA	CA	90401	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	7/18/2019	NON-COMPETING CONTINUATION	$335,972
														Subtotal = $335,972

Issue Date FY: 2018 ( Subtotal = $331,832 )
2018	2018	RAND CORPORATION, THE	1776 MAIN ST	SANTA MONICA	CA	90401	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	9/15/2018	NEW	$331,832
														Subtotal = $331,832

Grand Total All Awards = $1,973,305

Top

All Categories

About

Search

Reports

Data Submission

Award Information

Robust Statistical Methods to Identify and Use Surrogate Markers in Diabetes

Award Number: R01DK118354

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/15/2018

PERIOD OF PERFORMANCE END DATE: 06/30/2026

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer