Effectiveness of Continuous Glucose Monitoring on Short-Term, In-Hospital Mortality Among Frail and Critically Ill Patients With COVID-19: Randomized Controlled Trial.

Abstract

Background: The use of continuous glucose monitoring (CGM) in the hospital setting is growing, with more patients using these devices at home, especially during the COVID-19 pandemic. Frail and critically ill patients with COVID-19 and previously normal glucose tolerance are also associated with variability in their glucose levels during their intensive care unit (ICU) stay. However, very limited evidence supports the use of CGM in ICU settings, especially among frail patients with COVID-19.

Objective: We aimed to investigate the effectiveness of CGM on ICU-related outcomes among frail and critically ill patients with confirmed COVID-19.

Methods: This was an exploratory, prospective, open-label, parallel, single-center, randomized controlled trial. A total of 124 patients was finally analyzed. The primary outcome was 28-day, in-ICU mortality. The secondary outcome included the length of ICU stay as well as the occurrence of hypoglycemia and severe hypoglycemia events.

Results: The mean age was 78.3 (SD 11.5) years. The mean fasting glucose level and hemoglobin A_1c level at baseline were 8.12 (SD 1.54) mmol/L and 7.2% (SD 0.8%), respectively. The percentage of participants with diabetes was 30.6% (38/124). The corresponding hazard ratio of the primary outcome in the intermittently scanned CGM (isCGM) group when compared with the point-of-care testing (POCT) group was 0.18 (95% CI 0.04-0.79). The average length of ICU stay was 10.0 (SD 7.57) days in the isCGM group and 14.0 (SD 6.86) days in the POCT group (P=.02). At the end of study period, the mean value of fasting glucose in the isCGM group and the POCT group was 6.07 (SD 0.63) mmol/L and 7.76 (SD 0.62) mmol/L, respectively (P=.01). A total of 207 hypoglycemia events (<3.9 mmol/L) was detected, with 43 in the isCGM group and 164 in the POCT group (P<.001). A total of 81 severe hypoglycemia events (<2.8 mmol/L) was detected, with 16 in the isCGM group and 65 in the POCT group (P<.001). The major adverse event in this study was bleeding in the puncture site, with a total of 6 occurrences in the isCGM group. During the follow-up, none of the participants dropped out because of bleeding in the puncture site.

Conclusions: We found a significant clinical benefit from the use of CGM among frail and critically ill patients with COVID-19. These findings support the use of CGM in the ICU and might help with the extension of application in various in-hospital settings.

Trial registration: Chinese Clinical Trial Registry ChiCTR2200059733; https://www.chictr.org.cn/showproj.html?proj=169257.