Continuous glucose monitoring for hyperglycemia in critically ill patients: a randomized controlled trial.

Abstract

Background: Continuous glucose monitors (CGM) could potentially improve management of hyperglycemia compared to standard point of care glucose monitoring for critically ill patients. However, there is limited evidence to support routine use of CGM in the intensive care unit.

Research question: In critically ill patients with hyperglycemia, do CGM improve time within target glucose range compared to standard of care?

Study design and methods: This was an investigator-initiated, single-center, parallel-group, open-label, randomized controlled trial. Adult patients admitted to a medical or surgical intensive care unit, who had diabetes mellitus or hyperglycemia, and were treated with insulin were eligible for enrollment. Participants were randomly assigned to have glucose monitoring performed with CGM (intervention group) or standard of care (control group). Groups were compared for glycemic control and other relevant outcomes. The primary outcome for the study was percentage of time within the normoglycemic range, defined as 70-180 mg/dL (3.9-10 mmol/L).

Results: Eighty-five participants were enrolled and randomized to study groups with 43 participants in the intervention (CGM) group and 42 patients in the control (standard of care) group. For the primary outcome, there was no statistically significant difference between the intervention group (mean = 60.5%, SD = 30.5) and the control group (mean = 61.4%, SD = 28.3) in time within the goal glucose range (mean difference -0.9%, 95% CI -13.6 to 11.8, p = .9). Except for patient satisfaction, there were no statistically significant differences between groups for secondary and exploratory outcomes.

Interpretation: The results of this study do not support CGM as a superior method for routine glucose monitoring in the intensive care unit compared to standard of care.

Trial registry: This study was registered with ClinicalTrials.gov (NCT05442853).