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Comparing the effects of pharmacological treatment for gestational diabetes on long-term maternal and child health outcomes

Award Number: R01DK138135
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: 12/20/2023
PERIOD OF PERFORMANCE END DATE: 11/30/2027

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Comparing the effects of pharmacological treatment for gestational diabetes on long-term maternal and child health outcomes - Abstract Gestational diabetes mellitus (GDM) is among the most common complications of pregnancy and it increases the risk of perinatal complications and long-term sequelae for both the mother (subsequent diabetes) and the exposed child (obesity). Up to 50% of women with GDM require the addition of pharmacologic therapy during pregnancy. However, the long-term effects of pharmacologic treatment of GDM on maternal and child outcomes are unknown, making the optimal treatment unclear. We propose a longitudinal cohort study of more than 44,000 Kaiser Permanente members with time-varying exposure to metformin, glyburide, and insulin during pregnancy. Pregnancies diagnosed with GDM requiring pharmacologic treatment from 2008 to 2021 at Kaiser Permanente Northern and Southern California will be included. We will follow pregnant women and their children through our comprehensive electronic health record (EHR) for up to 18 years. We will take advantage of natural variation in clinical practice and changes over time in prescribing practices for first line medical therapy. The study population will consist of all women diagnosed with GDM who - after diet therapy - initiated pharmacotherapy within either insulin, glyburide, or metformin. We will use state-of-the-art causal and statistical methods that can emulate inferences from conceptual randomized controlled trials (RCTs) using observational data to inform the choice of pharmacologic treatment in a large, diverse population of women with GDM. This will be accomplished by conducting a series of real-world data cohort studies based on retrospective EHR data with inclusion/exclusion criteria and start of follow-up that mimic those of the RCTs emulated. We plan to conduct analyses for pregnant women diagnosed with GDM to compare the effects of static and dynamic treatment regimens with glyburide, metformin, and insulin on maternal diabetes risk after pregnancy and child growth and obesity risk. The static and dynamic treatment regimens will be specified to reflect current clinical practice and directly inform decisions on, not only, what initial drug type and dose to choose, but also, if and how to intensify treatment through increased drug dose or initiation of insulin when glycemia control is not reached with an oral agent. The incidence of maternal diabetes (Aim 1) and child growth and obesity (Aim 2) outcomes will be contrasted between any two static or dynamic regimens (e.g., sustained exposure to insulin versus exposure to glyburide unless glycemic control is not reached, at which time insulin is initiated). This study will yield results immediately applicable to clinical practice by providing head-to-head comparisons of pharmacologic GDM treatment strategies (metformin, glyburide, insulin) using state-of-the-art analytic methodology.


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 = $671,519 )
2026	2026	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	1/19/2026	NON-COMPETING CONTINUATION	$671,519
														Subtotal = $671,519

Issue Date FY: 2025 ( Subtotal = $672,314 )
2025	2025	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	11/25/2024	NON-COMPETING CONTINUATION	$605,082
2025	2025	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	2	7/16/2025	NON-COMPETING CONTINUATION	$67,232
														Subtotal = $672,314

Issue Date FY: 2024 ( Subtotal = $670,325 )
2024	2024	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	12/20/2023	NEW	$811,562
2024	2024	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	1	1/18/2024	NEW	-$16,500
2024	2024	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	1	12/21/2023	NEW	-$124,737
														Subtotal = $670,325

Grand Total All Awards = $2,014,158

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Comparing the effects of pharmacological treatment for gestational diabetes on long-term maternal and child health outcomes

Award Number: R01DK138135

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: 12/20/2023

PERIOD OF PERFORMANCE END DATE: 11/30/2027

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