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

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Τίτλος: Continuous glucose monitoring for high-risk type 2 diabetes in the hospital: the Cyber GEMS randomized controlled trial protocol.
Συγγραφείς: Spierling Bagsic SR; Department of Research & Development, Scripps Health, San Diego, CA 92121, United States. Electronic address: bagsic.samantha@scrippshealth.org., Fortmann AL; Department of Research & Development, Scripps Health, San Diego, CA 92121, United States., Bastian A; Department of Research & Development, Scripps Health, San Diego, CA 92121, United States., Belasco R; Department of Research & Development, Scripps Health, San Diego, CA 92121, United States., Sandoval H; Department of Research & Development, Scripps Health, San Diego, CA 92121, United States., Lohnes S; Scripps Whittier Diabetes Institute, Scripps Health, San Diego, CA 92121, United States., San Diego ERN; Scripps Whittier Diabetes Institute, Scripps Health, San Diego, CA 92121, United States., Talavera L; Scripps Whittier Diabetes Institute, Scripps Health, San Diego, CA 92121, United States., Philis-Tsimikas A; Scripps Whittier Diabetes Institute, Scripps Health, San Diego, CA 92121, United States.
Πηγή: Contemporary clinical trials [Contemp Clin Trials] 2026 Oct; Vol. 169, pp. 108411. Date of Electronic Publication: 2026 Jul 24.
Τύπος έκδοσης: Journal Article; Clinical Trial Protocol
Γλώσσα: English
Στοιχεία περιοδικού: Publisher: Elsevier Country of Publication: United States NLM ID: 101242342 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1559-2030 (Electronic) Linking ISSN: 15517144 NLM ISO Abbreviation: Contemp Clin Trials Subsets: MEDLINE
Imprint Name(s): Original Publication: New York, N.Y. : Elsevier, c2005-
Ιατρικοί όροι (MeSH): Diabetes Mellitus, Type 2*/blood , Diabetes Mellitus, Type 2*/drug therapy , Continuous Glucose Monitoring*/methods, Blood Glucose/analysis ; Insulin/therapeutic use ; Insulin/administration & dosage ; Hypoglycemia/prevention & control ; Hypoglycemia/diagnosis ; Hypoglycemia/chemically induced ; Hypoglycemic Agents/therapeutic use ; Hypoglycemic Agents/administration & dosage ; Cross Infection/prevention & control ; Cross Infection/epidemiology ; Blood Glucose Self-Monitoring/methods ; Humans ; Randomized Controlled Trials as Topic ; Remote Patient Monitoring ; Female ; Multicenter Studies as Topic ; Digital Health ; Dashboard Systems
Περίληψη: 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.
(Copyright © 2026. Published by Elsevier Inc.)
Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Samantha Rose Spierling Bagsic reports financial support was provided by National Institutes of Health. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
Contributed Indexing: Keywords: CGM; Continuous glucose monitoring; Diabetes; Glucose management; Hospital; Hospital-acquired infections; Inpatient
Substance Nomenclature: 0 (Blood Glucose)
0 (Insulin)
0 (Hypoglycemic Agents)
Entry Date(s): Date Created: 20260724 Date Completed: 20260912 Latest Revision: 20260916
Update Code: 20260917
DOI: 10.1016/j.cct.2026.108411
PMID: 42498081
Βάση Δεδομένων: MEDLINE
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– Name: Abstract
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  Data: 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.&lt;br /&gt;Methods: This in-progress study enrolls at 2 large disproportionate-share hospitals in Southern CA. Eligible patients are ≥18&#160;years with T2D and on subcutaneous insulin or with 2+ serum or POCT glucose ≥200&#160;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&#160;mg/dL), hypoglycemia (&amp;lt;70&#160;mg/dL) and severe hyperglycemia (&amp;gt;300&#160;mg/dL), as well as reducing hospital acquired infection in N&#160;=&#160;554 adults with T2D.&lt;br /&gt;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.&lt;br /&gt;Trials Registration: NCT05307237 Study Details|Continuous Glucose Monitoring for High-Risk Type 2 Diabetes in the Hospital (Cyber GEMS)|ClinicalTrials.gov.&lt;br /&gt; (Copyright &#169; 2026. Published by Elsevier Inc.)
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  Data: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Samantha Rose Spierling Bagsic reports financial support was provided by National Institutes of Health. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
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