Expanding Use of Continuous Glucose Monitoring Beyond COVID in Critical Care: Study Protocol for a Hybrid Implementation Trial

Abstract

Abstract Background Over the last 2 decades, continuous glucose monitoring (CGM) has been shown to improve glycemic control and patient outcomes in the outpatient setting, yet these technologies are not approved for inpatient use. Both hyperglycemia and hypoglycemia, which are common in the inpatient setting, are associated with increased morbidity, mortality, length of stay, and hospital costs. Point-of-care (POC) glucose monitoring has been the standard of care in the hospital setting since the late 1980’s, yet POC glucose monitoring implementation remains insufficient with frequent missed testing and missed timing of testing. Capabilities inherent to CGM (e.g., continuous measurement, hypoglycemia/hyperglycemia threshold alarms, predictive hypoglycemia alarms, trend data) hold the promise of improving glycemic control, patient outcomes, and nursing burden in the inpatient setting, yet ongoing research is needed to examine both outcomes and implementation of CGM in the inpatient environment. Methods This mixed methods hybrid II effectiveness-implementation study will examine patient outcomes and the feasibility of CGM implementation using a CGM plus (+) POC protocol among 100 patients on IV insulin in a single Midwest academic medical center’s medical intensive care unit (MICU). In this single arm clinical trial, we are pursuing 4 research questions (RQ): RQ 1. Establish the clinical utility, fidelity, and adoption of Dexcom G6 CGM as a tool for making dosing decisions within a CGM + POC protocol among medical intensive care unit (MICU) patients; RQ2. Assess the effects of CGM implementation on nursing workload and factors influencing nursing care delivery through surveys administered to MICU nurses and through a MICU staff nurse focus group (N = 10); RQ3. To assess glycemic control among patients receiving CGM in the CGM enabled MICU compared to historical control patients who received POC glucose monitoring in the MICU; RQ4. (exploratory) To assess hospitalization outcomes and conduct economic evaluation of the costs of delivering CGM implementation in the MICU. Discussion This trial that combines elements of effectiveness and implementation research will provide valuable data simultaneously evaluating patient outcomes and feasibility to enable more rapid adoption of CGM as standard of care. Trial registration: ClinicalTrials.gov, NCT03576989; Registered on 13 June 2018.