Continuous glucose monitoring for high-risk type 2 diabetes in the hospital: the cyber GEMS randomized controlled trial protocol

BACKGROUND: Continuous glucose monitoring (CGM) for inpatient management of type 2 diabetes (T2D) has been supported by small pilot studies and few randomized controlled trials. The Cloud‐Based Real‐Time Glucose Evaluation and Management System (Cyber GEMS) trial tests whether real‐time CGM can improve time in, above, and below target glycemic range, and reduce hospital acquired infections. METHODS: This in‐progress study enrolls at 2 large disproportionate‐share hospitals in Southern CA. Eligible patients are ≥18 years with T2D and on subcutaneous insulin or with 2+ serum or POCT glucose ≥200 mg/dL. Participants are randomized to usual care (UC) or Cyber GEMS with real‐time CGM for glucose monitoring and management. In Cyber GEMS, the CGM transmits values to three platforms for (1) remote hypoglycemia monitoring (Digital Dashboard); (2) real‐time management by bedside RN on a hospital unit iPad (FOLLOW app); and (3) clinical optimization by a remote diabetes RN specialist (CLARITY). In UC, a masked CGM is utilized for outcome evaluation purposes only. The study aims to determine the effectiveness of Cyber GEMS compared to UC in improving CGM‐measured % time in‐range (70‐200 mg/dL), hypoglycemia (<70 mg/dL) and severe hyperglycemia (>300 mg/dL), as well as reducing hospital acquired infection in N = 554 adults with T2D. DISCUSSION: The Cyber GEMS protocol is uniquely designed to evaluate the value and utility of real‐time CGM for optimizing hospital glucose management in a high‐risk, underserved T2D population. The uninterrupted remote monitoring, coupled with diabetes specialist oversight, aims to maximize the use of real‐time CGM data for optimal glucose management in T2D. The study is in progress and reaching a high‐risk underserved population. TRIALS REGISTRATION: NCT05307237 Study Details|Continuous Glucose Monitoring for High‐Risk Type 2 Diabetes in the Hospital (Cyber GEMS)|ClinicalTrials.gov.