Clinical studies of a bionic pancreas for automated glucose management in cystic fibrosis-related diabetes mellitus

Project SummaryRecent data suggest that diabetes is common in patients hospitalized with severe COVID-19 illness, andhyperglycemia during hospitalization has been associated with poor outcomes in this patient population. As withother infections, ensuring good glycemic control will be important for optimizing the care of patients admitted withCOVID-19; however, frequent glucose monitoring is time consuming, requires donning of personal protectiveequipment (PPE), and exposes healthcare workers to infection. The Dexcom G6 Continuous Glucose Monitoring(CGM) System provides real-time glucose data every 5 minutes and is approved for use in patients ages 2 andolder in the outpatient setting. The FDA has recognized the potential value of using CGM to allow hospital staffto remotely monitor glucose in inpatients with COVID-19, releasing a statement that they will not object if CGMcompanies provide devices and technical support to hospitals who want to implement CGM for glucosemonitoring to support COVID-19 healthcare efforts. Using the Dexcom G6 to monitor patients' glucose levelsremotely in real-time could significantly improve diabetes management by alerting providers to high or lowglucose values, reducing the burden of frequent in-person fingerstick glucose checks, limiting viral exposure ofhealthcare providers, and conserving PPE. However, given the lack of data confirming the accuracy of this devicein the hospital setting, particularly in critically ill patients with COVID-19, the introduction of this technology intoclinical use in the hospital and ICU setting requires a systematic approach to evaluate accuracy and safety priorto widespread use.We have developed a plan for introducing the Dexcom G6 into clinical use at Massachusetts General Hospital(MGH), using iterative quality assurance processes and comprehensive data collection to ensure safety andefficacy in this population. This will provide timely, real-life data to guide other health care organizations in theuse of this technology during the COVID-19 crisis. In this proposal, we will pursue the following three aims: (1)we will establish the accuracy of the G6 CGM in patients admitted in an ICU and on a medical floor, identifyingfactors that may impact CGM accuracy and instituting a calibration protocol to improve accuracy if needed; (2)we will investigate the feasibility of non-adjunctive use of the Dexcom G6 in critically ill and non-critically illpatients admitted with COVID-19; and (3) we will evaluate the safety and efficacy of the Dexcom G6 inhospitalized patients with COVID-19 in a nested case-control study of patients with diabetes admitted to MGH.The data collected in this proposal will provide critical information guiding Aim 3 of the parent grant, whichproposes to study an artificial pancreas device, the bionic pancreas (BP), in patients with cystic fibrosis relateddiabetes. Similar to those with COVID-19, patients with CF are often hospitalized with respiratory compromise,hypoxia, and hemodynamic instability. The BP utilizes the Dexcom G6 for glucose monitoring, so acquiring dataon the accuracy and performance of the Dexcom G6 in hospitalized COVID-19 patients would be very valuablefor informing this aim of the R01.