Ignite Creation Date:
2024-05-06 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 2:29 PM
Study NCT ID:
NCT05307237
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2021-11-11
Brief Title:
Continuous Glucose Monitoring for High-Risk Type 2 Diabetes in the Hospital Cyber GEMS
Sponsor:
Scripps Whittier Diabetes Institute
Organization:
Scripps Whittier Diabetes Institute
Study Overview
Official Title:
Continuous Glucose Monitoring for High-Risk Type 2 Diabetes in the Hospital Cloud-Based Real-Time Glucose Evaluation and Management System Cyber GEMS
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Cyber GEMS
Brief 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 eg 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 IIIII 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DK124427 | NIH | None | httpsreporternihgovquickSearchR01DK124427 |