ACCURACY AND CLINICAL SAFETY OF FREESTYLE LIBRE 2 CONTINUOUS GLUCOSE MONITORING IN HOSPITALIZED AND CRITICALLY ILL PATIENTS: A SYSTEMATIC REVIEW AND META-ANALYSIS

Author(s)

Sruthi Neelakantam, Masters in International Health Economics, ANTO AMITH BIJU J, Masters in International Health Economics, Abhishek Nair, MSc.
International Health and Pharmacoeconomics, Hochschule Fresenius University of Applied Sciences, Wiesbaden, Germany.
OBJECTIVES: Continuous glucose monitoring (CGM) is expanding into hospital settings, where glycemic variability affects outcomes and resource use. FreeStyle Libre 2 differs from earlier Libre generations in calibration and alarm functionality, and prior CGM-in-ICU reviews are device-agnostic. This study systematically reviews and meta-analyzes FreeStyle Libre 2 accuracy and clinical safety specifically in hospitalized adults.
METHODS: A systematic review following PRISMA 2020 is underway across PubMed, Embase, Cochrane CENTRAL, and Web of Science. Eligible studies report paired FreeStyle Libre 2-reference glucose measurements in hospitalized adults. Outcomes are mean absolute relative difference (MARD), error grid concordance, and safety events. A pre-specified contingent plan applies random-effects meta-analysis if ≥4 eligible studies are confirmed; narrative synthesis otherwise.
RESULTS: Three FreeStyle Libre 2- specific studies in hospitalized adults have been confirmed to date. In an intermediate care cohort (Portugal, n=23,414 paired readings vs. capillary point-of-care glucose), MARD was 18.62±11.87%, with 99.0% in Parkes Zones A+B; accuracy improved during intravenous fluid therapy and shock (p<0.001). In a mixed diabetic/non-diabetic ICU cohort (Italy, n=40, vs. arterial blood gas), MARD was 12±10%, with vasopressor use associated with reduced accuracy. A registered US perioperative trial (NCT05937373, Libre 2 vs. Dexcom G6 vs. laboratory glucose) has posted results, not yet extracted. The two confirmed quantitative studies differ substantially in point MARD estimates (18.6% vs. 12%) and show opposite-direction hemodynamic subgroup effects, plausibly reflecting differences in reference standard (capillary vs. arterial) rather than device performance alone.
CONCLUSIONS: Preliminary findings indicate FreeStyle Libre 2 retains clinical safety in hospitalized patients despite numerical accuracy below outpatient benchmarks but suggests reference-method selection and hemodynamic status materially affect observed accuracy, a factor existing device-agnostic CGM-ICU reviews have not isolated. If confirmed across the full search, this implies hospital CGM accuracy claims should be reference-standard-specific rather than generalized, with direct relevance to inpatient monitoring protocols and technology assessment.

Conference/Value in Health Info

2026-11, ISPOR Europe 2026, Vienna, Austria

Value in Health, Volume 29, Issue 12S

Code

CO105

Topic

Clinical Outcomes, Medical Technologies, Real World Data & Information Systems

Topic Subcategory

Comparative Effectiveness or Efficacy, Performance-based Outcomes

Disease

Diabetes/Endocrine/Metabolic Disorders (including obesity), No Additional Disease & Conditions/Specialized Treatment Areas

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