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Войти в исследования Contemporary clinical trials · 2026
Continuous glucose monitoring for high-risk type 2 diabetes in the hospital: the Cyber GEMS randomized controlled trial protocol.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Spierling Bagsic Samantha R, Fortmann Addie L, Bastian Alessandra, Belasco Rebekah, Sandoval Haley, Lohnes Suzanne, San Diego Emily Rose N, Talavera Laura, Philis-Tsimikas Athena
Аннотация
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.
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.