OBJECTIVE: Continuous glucose monitoring (CGM) may have benefits in achieving glycemic control in critically ill patients. The aim of this study was to assess the accuracy of the Freestyle Libre H (professional version similar to the Libre Pro) in patients with acute respiratory failure (ARF) in the intensive care unit (ICU).
METHODS: Fifty-two adult patients with ARF were selected. The performance of CGM was evaluated using the arterial blood glucose (aBG) and point-of-care (POC) glucose levels as the reference values. Numerical accuracy was evaluated by the mean absolute relative difference, Bland-Altman analysis, %15/15 (the percentage of CGM values within 15 mg/dL or 15% of reference values <100 or >100 mg/dL, respectively), %20/20, and %30/30. Clinical accuracy was assessed using the Clarke error grid analysis.
RESULTS: A total of 519 and 1504 pairs of aBG/CGM and POC/CGM glucose values were analyzed. The mean absolute relative difference values were 13.8% and 14.7%, respectively. The mean deviations of the Bland-Altman analysis were 0.82 mmol/L and 0.81 mmol/L. The proportions of CGM values within %15/15, %20/20, and %30/30 of the aBG values were 62.6%, 75.5%, and 92.4%, respectively; those within %15/15, %20/20, and %30/30 of the POC values were 57.1%, 72.9%, and 88.7%, respectively. The Clarke error grid analysis showed that 97.8% and 99.3% of the values were located in zone A + B. Additionally, the accuracy of CGM was not affected by general patient factors.
CONCLUSIONS: This study demonstrated that the accuracy of CGM in patients with ARF is lower than that in most outpatients and it is not affected by general patient factors. Whether CGM is beneficial to glucose management in the intensive care unit needs further evaluation.

Objective: Continuous glucose monitoring (CGM) devices are integral in the outpatient care of people with type 1 diabetes, although they lack inpatient labeling. Food and Drug Administration began allowing inpatient use during the coronavirus disease 2019 (COVID-19) pandemic, with some accuracy data now available, primarily from adult hospitals. Pediatric inpatient data remain limited, particularly during diabetic ketoacidosis (DKA) admissions and for patients receiving intravenous (IV) insulin. Design and Methods: This retrospective chart review compared point-of-care glucose values to personal Dexcom G6 sensor data during pediatric hospitalizations. Accuracy was assessed using mean absolute relative difference (MARD), Clarke Error Grids, and the percentage of values within 15/20/30% if glucose value >100 mg/dL and 15/20/30 mg/dL if glucose value ≤100 mg/dL. Results: Matched paired glucose values (N = 612) from 36 patients (median age 14 years, 58.3% non-Hispanic White, 47.2% male) and 42 inpatient encounters were included in this subanalysis of DKA admissions. The MARDs for DKA and non-DKA admissions (N = 503) were 11.8% and 11.7%, with 97.6% and 98.6% of pairs falling within A and B zones of the Clarke Error Grid, respectively. Severe DKA admissions (pH <7.15 and/or bicarbonate <5 mmol/L) had a MARD of 8.9% compared to 14.3% for nonsevere DKA admissions. The MARD during administration of IV insulin (N = 266) was 13.4%. Conclusions: CGM accuracy is similar between DKA and non-DKA admissions and is maintained in severe DKA and during IV insulin administration, suggesting potential usability in pediatric hospitalizations. Further study on the feasibility of implementation of CGM in the hospital is needed.

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Objective: Continuous glucose monitors (CGMs) used for type 1 diabetes management are associated with lower hemoglobin A1c. CGMs are not approved for inpatient use, when close glucose monitoring and intensive insulin management are essential for optimal health. Accuracy data from adult hospitalizations have been published, but pediatric data are limited. Design and Methods: This retrospective review of Dexcom G6 data from youth with type 1 diabetes during hospitalization assessed CGMs and matched (within 5 min) point-of-care (POC) and laboratory glucose values. Glucose values >400 and <40 mg/dL were excluded due to sensor reporting capabilities. Standard methods for CGM accuracy were used including mean absolute relative difference (MARD), Clarke Error Grids, and percentage of CGM values within 15%/20%/30% if glucose value is >100 mg/dL and 15/20/30 mg/dL if value is ≤100 mg/dL. Results: A total of 1120 POC and 288 laboratory-matched pairs were collected from 83 unique patients (median age 12.0 years, 68.7% non-Hispanic white, 54.2% male) during 100 admissions. For POC values, overall, MARD was 11.8%, that on the medical floor was 13.5%, and that in the intensive care unit was 7.9%. The MARD for all laboratory values was 6.5%. In total, 98% of matched pairs were within Clarke Error Grid A and B zones. Conclusions: Findings from our pediatric population were similar to accuracy reported in hospitalized adults, indicating the potential role for CGM use during pediatric hospitalizations. Additional research is needed to assess accuracy under various conditions, including medication use, as well as development of safe hospital protocols for successful CGM implementation for routine inpatient care.

OBJECTIVE: Patients hospitalized with COVID-19 and hyperglycemia require frequent glucose monitoring, usually performed with glucometers. Continuous glucose monitors (CGMs) are common in the outpatient setting but not yet approved for hospital use. We evaluated CGM accuracy, safety for insulin dosing, and CGM clinical reliability in 20 adult patients hospitalized with COVID-19 and hyperglycemia.
METHODS: Study patients were fitted with a remotely monitored CGM. CGM values were evaluated against glucometer readings. The CGM sensor calibration was performed if necessary. CGM values were used to dose insulin, without glucometer confirmation.
RESULTS: CGM accuracy against glucometer, expressed as mean absolute relative difference (MARD), was calculated using 812 paired glucometer-CGM values. The aggregate MARD was 10.4%. For time in range and grades 1 and 2 hyperglycemia, MARD was 11.4%, 9.4%, and 9.1%, respectively, with a small variation between medical floors and intensive care units. There was no MARD correlation with mean arterial blood pressure levels, oxygen saturation, daily hemoglobin levels, and glomerular filtration rates. CGM clinical reliability was high, with 99.7% of the CGM values falling within the \"safe\" zones of Clarke error grid. After CGM placement, the frequency of glucometer measurements decreased from 5 to 3 and then 2 per day, reducing nurse presence in patient rooms and limiting viral exposure.
CONCLUSIONS: With twice daily, on-demand calibration, the inpatient CGM use was safe for insulin dosing, decreasing the frequency of glucometer fingersticks. For glucose levels >70 mg/dL, CGMs showed adequate accuracy, without interference from vital and laboratory values.

In an article in the Journal of Diabetes Science and Technology, Ji et al. report on the accuracy of a new factory calibrated continuous glucose monitoring system, the AiDEX CGM (Microtech Medical Company, Ltd., Hangzhou, China). This is the first report from a new manufacturer of a highly accurate factory calibrated CGM. The authors report that the accuracy of the AiDEX CGM is comparable to previous results from Abbott Diabetes Care and Dexcom. However, the study protocol was significantly different from previous studies. This study is the first of numerous studies likely from other manufacturers of CGM technology. It raises the question of how to evaluate sensor performance in the coming era of mass adoption of CGM and increased use of automated insulin delivery systems.

UNASSIGNED: Continuous glucose monitoring (CGM) is widely used in the outpatient setting for people with diabetes and has been limited to investigational use only for the inpatient population. In April 2020, the US FDA exercised enforcement discretion for the temporary use of inpatient CGM during the pandemic, thus hospitals were presented the opportunity to implement this technology.
UNASSIGNED: We sought to investigate the accuracy of CGM in hospitalized patients on general care floors and the intensive care unit (ICU) in attempts to decrease healthcare professional exposure to COVID-19 and ultimately improve glycemic management of patients affected by COVID-19. Point of care (POC) and laboratory (Lab) glucose values were matched with simultaneous CGM glucose values and measures of accuracy were performed to evaluate the safety and usability of CGM in this population. Our data are presented drawing a distinction between POC and Lab as reference glucose sources.
UNASSIGNED: In 808 paired samples obtained from 28 patients (10 ICU, 18 general floor), overall mean absolute relative difference (MARD) for all patients using either POC or Lab as reference was 13.2%. When using POC as the reference glucose MARD was 13.9% and using Lab glucose as reference 10.9%. Using both POC and Lab reference glucose pairs the overall MARD for critical care patients was 12.1% and for general floor patients 14%.
UNASSIGNED: We determined, with proper protocols and safeguards in place, use of CGM in the hospitalized patient is a reasonable alternative to standard of care to achieve the goal of reducing healthcare professional exposure. Further study is necessary to validate safety, accuracy, and efficacy of this technology. Investigation and analysis are necessary for the development of protocols to utilize CGM trend arrows, alerts, and alarms.

With the increasing accuracy of continuous glucose monitors (CGM) have come calls for the Food and Drug Administration (FDA) to label these devices as safe for nonadjunctive dosing of insulin. However, there is evidence that these devices are subject to sporadic, unpredictable, large errors. A text analysis of reports to the FDA MAUDE database since 2015 reveals over 25 000 complaints of CGM sensor inaccuracy, with instances directly leading to serious outcomes. These new data were not considered at a recent FDA Advisory Panel meeting that voted to approve Dexcom G5 relabeling for nonadjunctive use. Social media is another source of surveillance data providing evidence of large CGM inaccuracies in real-world use. We need to improve safety procedures, not remove them. CGMs offer unique information and alerts for managing diabetes, but the issue is not whether they are better than other approaches to monitoring glucose, but how they can be best used in conjunction with devices that offer the confirmatory readings needed for patient safety.

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