Clinical trial NCT05307237: Continuous Glucose Monitoring for High-Risk Type 2 Diabetes in the Hospital (Cyber GEMS)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes
Hospital
Continous Glucose Monitoring
Lead sponsor: Scripps Whittier Diabetes Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-04-01
Enrollment: 554
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 (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.

Eligibility criteria: Inclusion Criteria:

* Documented previous or current Type 2 Diabetes (T2D) diagnosis as defined by either diagnosis in the chart or an HbA1c \> or = to 6.5% in the last 90 days
* Either on subcutaneous (SQ) insulin orders, or greater than two serum or Point of Care (POC) glucose \> or = 200 mg/dL in most recent 24 hours of admission

Exclusion Criteria:

* Anticipated length of stay \< 24 hours;
* Current or anticipated ICU placement;
* Does not speak English or Spanish;
* Known allergy to adhesives;
* Current participation in any medication or device research study;
* Pregnant;
* Any other condition that Multiple Principal Investigator (MPI) Philis-Tsimikas or the attending physician deems contraindicated

Primary outcomes:
measure: Percent time in range
timeFrame: Immediately following intervention completion
measure: Percent time spent in hypoglycemia and percent time in severe hyperglycemia
timeFrame: Immediately following intervention completion
measure: Infection Rate
timeFrame: Immediately following intervention completion
Secondary outcomes:
measure: Glucose Variability
timeFrame: Immediately following intervention completion
measure: Electronic Medical Record (EMR) - Derived Outcomes: HbA1C
timeFrame: Immediately following intervention completion
measure: Electronic Medical Record (EMR) - Derived Outcome: fasting POC blood glucose
timeFrame: Immediately following intervention completion
Other outcomes:
measure: Process Indicators (Reach): Enrollment Characteristics
timeFrame: Immediately following intervention completion
measure: Process Indicators (Reach): Representative Characteristics
timeFrame: Immediately following intervention completion
measure: Process Indicators (Reach): CGM wear time
timeFrame: Immediately following intervention completion
measure: Process Indicators (Reach): Withdrawal rate
timeFrame: Immediately following intervention completion
measure: Process Indicators (Efficacy): Impact of time on CGM
timeFrame: Immediately following intervention completion
measure: Process Indicators (Efficacy): Negative outcomes
timeFrame: Immediately following intervention completion
measure: Process Indicators (Adoption): Perceptions of CGM
timeFrame: Immediately following intervention completion
measure: Process Indicators (Adoption): Clinical perceptions of glucose management
timeFrame: Immediately following intervention completion
measure: Process Indicators (Implementation): Alarm actions
timeFrame: Immediately following intervention completion
measure: Process Indicators (Implementation): CGM satisfaction
timeFrame: Immediately following intervention completion
measure: Process Indicators (Maintenance): Enrollment progress
timeFrame: Immediately following intervention completion
measure: Process Indicators (Maintenance): Stakeholder and advisory board feedback
timeFrame: Immediately following intervention completion
Locations:
city: Chula Vista
country: United States
facility: Scripps Mercy Hospital
state: California
Study officials:
affiliation: Scripps Whittier Diabetes Institute
name: Athena Philis-Tsimikas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Scripps Whittier Diabetes Institute
name: Addie Fortmann, PhD
role: PRINCIPAL_INVESTIGATOR
References: