NCT05307237

Continuous Glucose Monitoring for High-Risk Type 2 Diabetes in the Hospital (Cyber GEMS)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 518 (actual)
• Sponsor: Scripps Whittier Diabetes Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Given the known serious consequences of uncontrolled blood sugars during hospitalization, this research plans to study an alternative seamlessly integrated continuous glucose monitoring (CGM) system in the hospital to test a dynamic and digitized, team-based approach to glucose management in an underserved and understudied, yet high-risk population. A digital dashboard will facilitate real-time, remote monitoring of a large volume of patients simultaneously; automatically identify and prioritize patients for intervention; and will detect any and all potentially dangerous hypoglycemic episodes in a hospital environment. The study will focus on clinical metrics of glucose control and infection that are in-line with patient priorities and US hospital quality initiatives.

Detailed description

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. Despite the widespread use and demonstrated effectiveness of continuous glucose monitoring (CGM) for ambulatory glucose management, CGMs is not routinely used in US hospitals. 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 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. This study is a randomized controlled trial, defined as a Phase II/III 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. Aim 2 will evaluate the effectiveness of Cyber GEMS versus UC in decreasing hospital-acquired infection risk. A digital dashboard will facilitate real-time, wireless transmission of glucose data of a large volume of patients simultaneously; automatically identify and prioritize patients for intervention; and detect potentially dangerous hypoglycemic episodes - all at a reduced burden than current methods of stratification and review. The uninterrupted coverage, and 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.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DEVICE	Dexcom G6 Continous Glucose Monitoring Management	CGM data will be transmitted from the bedside iPhone to web-based platforms for: (1) Real-Time Management (via iPad-based FOLLOW app used by bedside RN and Digital Dashboard used by the remote monitoring team) and (2) Clinical Optimization (via CLARITY, by which a Diabetes RN Coordinator will conduct remote clinical management of patients from a central, Scripps Diabetes Hub.
DEVICE	Usual Care - Blinded Continuous Glucose Monitoring Management	CGM data will be blinded and used for evaluation purposes only. Glucose will be monitored via the hospital's standard POC testing protocol (i.e., prior to meals and at bedtime for patients who are eating, and every 4-6 waking hours if not eating). Glucose management in UC is designed to minimize differences between groups, aside from CGM monitoring.

Timeline

• Start date: 2022-04-19
• Primary completion: 2025-12-17
• Completion: 2025-12-17
• First posted: 2022-04-01
• Last updated: 2026-03-09

Locations

1 site across 1 country: United States