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Continuous Glucose Monitoring for High-Risk Type 2 Diabetes in the Hospital: Cloud-Based Real-Time Glucose Evaluation and Management System (Cyber GEMS)

Award Number: R01DK124427
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: 07/27/2021
PERIOD OF PERFORMANCE END DATE: 05/31/2026

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Continuous Glucose Monitoring for High-Risk Type 2 Diabetes in the Hospital: Cloud-Based Real-Time Glucose Evaluation and Management System (Cyber GEMS) - 7. Project Summary/Abstract There is strong evidence that poor glycemic control in the hospital is common. Given the known consequences of uncontrolled blood sugars during a hospitalization (e.g., infection, serious neurological and cardiac complications, mortality, longer lengths of stay, readmissions, higher healthcare costs), health systems devote significant resources to developing protocols for improving glucometrics. Surprisingly, despite the widespread use and demonstrated effectiveness of continuous glucose monitoring (CGM) for ambulatory glucose management, CGMs are not currently used in any US hospital. Therefore, the long-term goal to develop Cloud-Based Real-Time Glucose Evaluation and Management System (Cyber GEMS) is to provide an effective, real-time solution to augment existing processes, to provide a valuable test of real-world effectiveness, while capitalizing on standardized algorithms to facilitate sustainability and scalability to other systems and at-risk populations. The innovative intervention will enable hospital care teams to take immediate steps based on the wireless transmission of glucose data from the Dexcom G6 device, sent to a Digital Dashboard, where integration with existing real-world hospital processes can provide immediate prioritization to prevent or correct impending hypoglycemia and severe hyperglycemic events. The first step toward this long-term goal is a randomized controlled trial, defined as a Phase III/IV definitive clinical trial that in turn establishes efficacy and effectiveness of this intervention. Aim 1 will establish the effectiveness of Cyber GEMS versus Usual Care (UC) in increasing the % time patients are in-range and decreasing % time in hypoglycemia and severe hyperglycemia during hospitalization. Simultaneously, Aim 2 will evaluate the effectiveness of Cyber GEMS versus UC in decreasing hospital-acquired infection risk. The described Digital Dashboard is progressive, as it facilitates real-time, wireless transmission of glucose data of a large volume of patients simultaneously; automatically identifies and prioritizes patients for intervention; and detects potentially dangerous hypoglycemic episodes – all at a reduced burden than current methods of stratification and review. The uninterrupted coverage by telemetry, coupled with efficient and remote diabetes specialist oversight in Cyber GEMS is a scalable, novel, team-based approach to maximize the use of continuously streaming CGM data for optimal glucose management. The work proposed pushes the limits of these challenges by providing evidence, identified by a team-based approach to glucose management in an underserved and understudied population, supplementing prior data designed to improve outcomes among high-risk patients with T2D and related cardiometabolic conditions.


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 = $615,143 )
2025	2025	SCRIPPS HEALTH	4555 EXECUTIVE DR	SAN DIEGO	CA	92121	SAN DIEGO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	5	6/3/2025	NON-COMPETING CONTINUATION	$615,143
2025	2024	SCRIPPS HEALTH	4555 EXECUTIVE DR	SAN DIEGO	CA	92121	SAN DIEGO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	4/29/2025	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $615,143

Issue Date FY: 2024 ( Subtotal = $673,579 )
2024	2024	SCRIPPS HEALTH	4275 CAMPUS POINT CT	SAN DIEGO	CA	92121	SAN DIEGO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	4	8/26/2024	SUPPLEMENT FOR EXPANSION	$80,653
2024	2024	SCRIPPS HEALTH	4275 CAMPUS POINT CT	SAN DIEGO	CA	92121	SAN DIEGO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	5/27/2024	NON-COMPETING CONTINUATION	$592,926
														Subtotal = $673,579

Issue Date FY: 2023 ( Subtotal = $791,931 )
2023	2023	SCRIPPS HEALTH	10140 CAMPUS POINT DR	SAN DIEGO	CA	92121	SAN DIEGO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	3	8/23/2023	SUPPLEMENT FOR EXPANSION	$174,300
2023	2023	SCRIPPS HEALTH	10140 CAMPUS POINT DR	SAN DIEGO	CA	92121	SAN DIEGO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	5/23/2023	NON-COMPETING CONTINUATION	$617,631
														Subtotal = $791,931

Issue Date FY: 2022 ( Subtotal = $617,631 )
2022	2022	SCRIPPS HEALTH	10140 CAMPUS POINT DR, CPA 415	SAN DIEGO	CA	92121	SAN DIEGO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	6/9/2022	NON-COMPETING CONTINUATION	$617,631
														Subtotal = $617,631

Issue Date FY: 2021 ( Subtotal = $608,174 )
2021	2021	SCRIPPS HEALTH	10140 CAMPUS POINT DR, CPA 415	SAN DIEGO	CA	92121	SAN DIEGO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	7/27/2021	NEW	$608,174
														Subtotal = $608,174

Grand Total All Awards = $3,306,458

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Continuous Glucose Monitoring for High-Risk Type 2 Diabetes in the Hospital: Cloud-Based Real-Time Glucose Evaluation and Management System (Cyber GEMS)

Award Number: R01DK124427

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: 07/27/2021

PERIOD OF PERFORMANCE END DATE: 05/31/2026

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