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Continuous Glucose Monitoring-Guided Insulin Administration in Hospitalized Patients with Diabetes: A Randomized Clinical Trial

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posted on 2022-08-19, 15:02 authored by Elias K. Spanakis, Agustina Urrutia, Rodolfo Galindo, Priyathama Vellanki, Alexandra L. Migdal, Georgia Davis, Thaer Idrees, Francisco J. Pasquel, Walkiria Zamudio Coronado, Bonnie Albury, Emmenlin Moreno, Lakshmi G. Singh, Isabel Marcano, Sergio Lizama, Chikara Gothong, Kashif Munir, Catalina Chesney, Rebecca Maguire, William H. Scott, M. Citlalli Perez-Guzman, Saumeth Cardona, Limin Peng, Guillermo E. Umpierrez

  

Background: The efficacy and safety of continuous glucose monitoring (CGM) in adjusting inpatient insulin therapy has not been evaluated. 

Methods: This randomized trial included 185 general medicine and surgery patients with type 1 and type 2 diabetes treated with a basal bolus insulin regimen. All subjects underwent point-of-care (POC) capillary glucose testing before meals and bedtime. Patients in the standard of care (POC group) wore a blinded Dexcom G6 CGM with insulin dose adjusted based on POC results; while in the CGM group, insulin adjustment was based on daily CGM profile. Primary endpoints were differences in time in range (TIR, 70-180 mg/dL) and hypoglycemia (<70 mg/dL and <54 mg/dL). 

Results: There were no significant differences in TIR (54.51%±27.72 vs 48.64%±24.25, p=0.14), mean daily glucose (183.2±40 mg/dL vs 186.8±39 mg/dL, p=0.36), percent of patients with CGM values <70 mg/dL (36% vs 39%, p=0.68) or <54mg/dL (14% vs 24%, p=0.12) between CGM-guided and POC group. Among patients with ³ 1 hypoglycemic event, compared to POC, the CGM group experienced a significant reduction in hypoglycemia reoccurrence (1.80±1.54 vs 2.94±2.76 events/patient, p=0.03), lower percentage of time below range (TBR) <70 mg/dL (1.89%±3.27 vs 5.47%±8.49, p=0.02), and lower incidence-rate ratio <70 mg/dL (0.53, 95% CI:0.31-0.92) and <54 mg/dL (0.37, 95% CI:0.17-0.83).

Conclusion: The inpatient use of real-time Dexcom G6 CGM is safe and effective in guiding insulin therapy resulting in a similar improvement in glycemic control and a significant reduction of recurrent hypoglycemic events compared to POC-guided insulin adjustment.

Funding

EKS is supported in part by the VA MERIT award (#1I01CX001825) from the United States (U.S.) Department of Veterans Affairs Clinical Sciences Research and Development Service and has received unrestricted research support from Dexcom (to Baltimore VA Medical Center and to University of Maryland) to conduct clinical trials. RJG is partially supported by research grants from NIH/NIDDK P30DK111024 and 1K23DK123384-03. RJG received research support to Emory University for investigator-initiated studies from Novo Nordisk, Dexcom and Eli Lilly and consulting fees from Sanofi, Eli Lilly, and Weight Watchers, outside of this work. PV is supported in part by NIH grant 1K23DK113241 and has received consulting fees from Merck and Boehringer-Ingelheim. GMD is supported National Institute of Health (NIH) under Award Number 1K23DK122199-01A1 and has received research support from Insulet. FJP is supported in part by NIH grants K23GM128221 and P30DK111024-06 and has received research support from Merck, Dexcom, and Insulet, and consulting fees from Boehringer Ingelheim, Eli Lilly, Dexcom, and Medscape. GEU is partly supported by research grants from National Institutes of Health (NIH/NATS UL 3UL1TR002378-05S2) from the Clinical and Translational Science Award program, and from National Institutes of Health and National Center for Research Resources (NIH/NIDDK 2P30DK111024-06). GEU has received research support (to Emory University) from Astra Zeneca, Bayer and Dexcom. AU, AM, TI, WZC, BA, LGS, IM, SL, CG, Disclaimer: The contents do not represent the views of the U.S. Department of Veterans Affairs or the United States Government.

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