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

Information

  • Research Project
  • 10119606
  • ApplicationId
    10119606
  • Core Project Number
    R01DK124427
  • Full Project Number
    1R01DK124427-01A1
  • Serial Number
    124427
  • FOA Number
    PA-18-330
  • Sub Project Id
  • Project Start Date
    7/27/2021 - 3 years ago
  • Project End Date
    5/31/2026 - a year from now
  • Program Officer Name
    BURCH, HENRY B
  • Budget Start Date
    7/27/2021 - 3 years ago
  • Budget End Date
    5/31/2022 - 2 years ago
  • Fiscal Year
    2021
  • Support Year
    01
  • Suffix
    A1
  • Award Notice Date
    7/27/2021 - 3 years ago
Organizations

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.

IC Name
NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
  • Activity
    R01
  • Administering IC
    DK
  • Application Type
    1
  • Direct Cost Amount
    434232
  • Indirect Cost Amount
    173942
  • Total Cost
    608174
  • Sub Project Total Cost
  • ARRA Funded
    False
  • CFDA Code
    847
  • Ed Inst. Type
  • Funding ICs
    NIDDK:608174\
  • Funding Mechanism
    Non-SBIR/STTR RPGs
  • Study Section
    NRCS
  • Study Section Name
    Nursing and Related Clinical Sciences Study Section
  • Organization Name
    SCRIPPS HEALTH
  • Organization Department
  • Organization DUNS
    131185241
  • Organization City
    SAN DIEGO
  • Organization State
    CA
  • Organization Country
    UNITED STATES
  • Organization Zip Code
    921211520
  • Organization District
    UNITED STATES