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ChartGlucose4Moms: Characterizing, by Trimester, Continuous Glucose Monitoring Measurements for determining effects on Maternal & Offspring Metabolic Sequelae

Award Number: U01DK123791
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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PROJECT SUMMARY/ABSTRACT: Gestational diabetes (GDM) rates are on the rise in the US, particularly among racial and ethnic minorities. GDM is associated with higher rates of large for gestational age (LGA) infants, C-section, and serious perinatal complications, and increased long-term risks of Type 2 diabetes and morbidity in both mothers and infants. Women who get treatment for GDM are less likely to experience perinatal complications and give birth to LGA infants than those who do not; therefore, rapid detection of GDM may be critical to reducing perinatal complications and disparities in birth outcomes. GDM is normally diagnosed by oral glucose tolerance testing (OGTT) at 24-28 weeks gestation, but clinically important insulin resistance and metabolic dysfunction may be missed by not testing earlier. A metabolically unhealthy uterine environment in early pregnancy may lead to long-term negative impacts on mother and child, but how and when to test for insulin resistance and associated metabolic dysfunction in pregnancy is poorly defined. More data are needed on how glucose levels and other metabolic measures change across pregnancy to better evaluate women's metabolic risks and how those risks relate to perinatal and long-term outcomes. Using continuous glucose monitoring (CGM) and metabolic biomarker assays, we will describe detailed metabolic phenotype profiles over the course of pregnancy and examine how they are associated with perinatal and postpartum outcomes. We propose to recruit a diverse sample of 400 women in their first trimester from Kaiser Permanente Northwest and Kaiser Permanente Hawaii and to perform CGM, OGTT, and obtain biomarkers at 12 weeks, 20 weeks, and 28 weeks of gestation to examine how these measures relate to each other and to perinatal outcomes. Aim 1 and Aim 3 will assess the effects of CGM variables (Aim 1) and OGTT and other biomarkers (Aim 3) at each time point on the risk of LGA, other perinatal outcomes, and postpartum diabetes. Aim 2 will assess the relationship between CGM variables and diagnosis of GDM by OGTT, as well as the relationship between CGM variables and other metabolic biomarkers. We hypothesize that dysglycemia is just one marker of a much larger metabolic dysregulation that can be characterized through the work of this consortium. Characterizing a broader spectrum of metabolic dysregulation and its association with adverse perinatal outcomes will lead to improved screening regimens and treatments for pregnant women and better outcomes for both mothers and babies.


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: 2024 ( Subtotal = $0 )
2024	2023	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	3/29/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $538,992 )
2023	2023	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	003	4	9/4/2023	NON-COMPETING CONTINUATION	$538,992
2023	2022	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	4/26/2023	NON-COMPETING CONTINUATION	$0
2023	2022	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	3	7/27/2023	NON-COMPETING CONTINUATION	$0
2023	2019	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	1	8/9/2023	NEW	$0
														Subtotal = $538,992

Issue Date FY: 2022 ( Subtotal = $673,230 )
2022	2022	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	3	9/6/2022	NON-COMPETING CONTINUATION	$673,230
2022	2020	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	2	5/10/2022	NON-COMPETING CONTINUATION	$0
2022	2020	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	1/13/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $673,230

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2020	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	11/26/2020	NON-COMPETING CONTINUATION	$0
2021	2020	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	2	6/23/2021	NON-COMPETING CONTINUATION	$0
2021	2020	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	2	2/19/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $662,614 )
2020	2020	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	9/1/2020	NON-COMPETING CONTINUATION	$662,614
														Subtotal = $662,614

Issue Date FY: 2019 ( Subtotal = $800,511 )
2019	2019	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	9/20/2019	NEW	$800,511
														Subtotal = $800,511

Grand Total All Awards = $2,675,347

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ChartGlucose4Moms: Characterizing, by Trimester, Continuous Glucose Monitoring Measurements for determining effects on Maternal & Offspring Metabolic Sequelae

Award Number: U01DK123791

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

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