7. Project Summary/Abstract (Parent Cyber GEMS study, R01DK124427)
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.
