Time at High Risk of Hypoglycemia: Validation of a Consensus-Based Continuous Glucose Monitoring-Metric for Hospitalized Patients

Abstract

Background: Time at high risk of hypoglycemia (THRH), 3.9 to 5.6 mmol/L, is a continuous glucose monitoring (CGM)-based metric recommended for reporting in hospitalized patients. This study aims to validate THRH as a predictor of hypoglycemia.

Methods: The CGM data from 166 non-intensive care unit (non-ICU) inpatients with type 2 diabetes from the DIATEC trial were analyzed. All participants received basal-bolus insulin therapy. Of these, 82 were monitored with point-of-care glucose testing and blinded CGM, while 84 had open CGM. Linear and negative binomial regression analyses assessed the relationship between THRH and time below range (TBR) (<3.0 mmol/L, 3.0-3.9 mmol/L, and <3.9 mmol/L) and hypoglycemic events. Analyses were conducted for day (07:00-23:00), night (23:01-06:59), and 24-hour periods.

Results: For CGM-monitored patients, every 10%-point increase in THRH was associated with a 0.13%-point increase in TBR (<3.0 mmol/L) (95% confidence interval [CI] = 0.06-0.21), 0.66%-point increase in TBR (3.0-3.9 mmol/L) (95% CI = 0.47-0.86), and 0.74%-point increase in TBR (<3.9 mmol/L) (95% CI = 0.51-0.97), all P < .001. A THRH threshold below 50% was linked to a TBR <3.9 mmol/L of less than 4%, as recommended. Similar results were observed during both day and night analyses and for point-of-care monitored patients, also for hypoglycemic events.

Conclusions: The THRH is strongly associated with hypoglycemia in non-ICU hospitalized patients with type 2 diabetes on basal-bolus insulin. Aiming for THRH below 50% aligns with the recommended TBR target of <3.9 mmol/L below 4%, supporting THRH's role in guiding hypoglycemia prevention strategies.

Keywords: consensus; continuous glucose monitoring; hypoglycemia; inpatient; time at high risk of hypoglycemia.

Figure 1.

Scatterplots with regression lines (solid lines) and 95% confidence intervals (stippled lines) for the associations between time at high risk of hypoglycemia (3.9-5.6 mmol/L) and time below range <3.9 mmol/L (left panel) and time below range <3.0 mmol/L (right panel) in non-intensive care unit patients with type 2 diabetes monitored by blinded or open continuous glucose monitoring (CGM) during the entire hospitalization.