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. 2025 Apr 11:19322968251331600.
doi: 10.1177/19322968251331600. Online ahead of print.

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

Mikkel Thor Olsen  1 , Katrine Bagge Hansen  2 , Ulrik Pedersen-Bjergaard  1   3 , Peter Lommer Kristensen  1   3
Affiliations

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

Mikkel Thor Olsen et al. J Diabetes Sci Technol. .

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.

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Conflict of interest statement

The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: UPB received speaker fees from Sanofi and Novo Nordisk and has served on advisory boards for Sanofi, Novo Nordisk, and Vertex. Additional authors declare no conflict of interest.

Figures

Figure 1.
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.
See this image and copyright information in PMC

References

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