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Quantifying proteins in plasma do democratize personalized medicine for patients with type 1 diabetes

Award Number: U01DK137097
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: 07/21/2023
PERIOD OF PERFORMANCE END DATE: 06/30/2027

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Quantifying proteins in plasma do democratize personalized medicine for patients with type 1 diabetes - ABSTRACT Type 1 diabetes affects more than 1.25 million people in the United States and the annual incidence is increasing at an alarming rate of 3-4%. The emotional and financial burden of the disease is overwhelming and we currently have no way to predict or prevent new cases. As we gain a better understanding of the pathophysiological processes in the pancreas and the downstream effects of hyperglycemia (and periodic hypoglycemia during treatment), more robust biomarker assays are needed to improve the reproducibility of research findings and to translate those findings to clinical care. One technology that can provide robust, transferable assays for the measurement of proteins is liquid chromatography-tandem mass spectrometry. By directly detecting the analyte of interest, assays that use mass spectrometry detection can have better specificity than immunoassays and when paired with enrichment strategies, they can also be very sensitive. As we have demonstrated previously, it is straightforward to harmonize the results of mass spectrometric assays, which is significantly more difficult for immunoassays in general. This proposal aims to generate and validate novel transferable protein assays that harness the power of mass spectrometry. We aim to leverage a new method for the enrichment of extracellular vesicles and new de novo proteins for affinity enrichment, called minibinders, to help with sensitivity of the methods. Whenever possible, assays will be multiplexed and if antibodies are required for enrichment, they will be widely distributed through the Iowa Hybridoma Bank. Plasmids encoding minibinders will be deposited at Addgene. Chromatographic data from method development (particularly peptide selection, which will use narrow-window data-independent acquisition rather than relying on algorithms or data- dependent acquisition methods) as well as chromatographic data from method validation will be distributed via Panorama, along with detailed standard operating procedures. As requested in RFA DK-21-031, a portion of the assays produced will target glucagon, other fragments of proglucagon, proinsulin and its fragments, glycated soluble CD59, amylin, and the chromogranins. Our Target Prioritization Committee will help identify the most important proteins to add to this list and focus our development efforts.


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 = $816,554 )
2026	2026	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	5/22/2026	NON-COMPETING CONTINUATION	$816,554
														Subtotal = $816,554

Issue Date FY: 2025 ( Subtotal = $828,866 )
2025	2025	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	3	5/26/2025	NON-COMPETING CONTINUATION	$828,866
2025	2024	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	12/16/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $828,866

Issue Date FY: 2024 ( Subtotal = $848,497 )
2024	2024	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	6/17/2024	NON-COMPETING CONTINUATION	$848,497
														Subtotal = $848,497

Issue Date FY: 2023 ( Subtotal = $867,679 )
2023	2023	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	7/20/2023	NEW	$867,679
														Subtotal = $867,679

Grand Total All Awards = $3,361,596

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Quantifying proteins in plasma do democratize personalized medicine for patients with type 1 diabetes

Award Number: U01DK137097

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: 07/21/2023

PERIOD OF PERFORMANCE END DATE: 06/30/2027

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