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Introduction <p>FreeStyle Libre (FSL) systems are effective and user-friendly glucose monitoring devices. This cost-effectiveness analysis compared FSL vs. self-blood glucose monitoring (SBGM) in patients with poorly controlled [hemoglobin A1c (HbA1c) &gt; 8%] type 2 diabetes (T2DM) on basal insulin, from the Spanish National Health System perspective.</p> Methods <p>The DEDUCE model, which simulated 10,000 patients with T2DM over a 50&#xa0;years’ time horizon (annual discount rate = 3.00%), was adapted to the Spanish setting. The population characteristics, frequency of acute and chronic diabetic complications, costs (€, 2025) and utilities/disutilities proceeded from scientific literature and were validated by national multidisciplinary experts. The annual probabilities of acute events associated with SBGM were 17.02% for non-severe hypoglycemia (SHE) (€3.92; disutility = – 0.0016), 2.50% for SHE (€1031.69; disutility = – 0.0470) and 0.25% for ketoacidosis (DKA) (€2523.93; disutility = – 0.0470). The RECODe risk engine was used to model chronic diabetic complications (myocardial infarction [€1248.44–€31,013.22; disutility = – 0.0550]; heart failure [€1523.14–6505.08; disutility = – 0.1080]; stroke [€3187.92–7849.48; disutility = – 0.1640]; blindness [€2943.37; disutility = – 0.0740]; renal failure [€4057.05–42,757.39; disutility = – 0.2040]). According to the Spanish recommendations, a patient with SBGM required 2.5 reactive strips/day and 2.5 lancets/day (€0.57/strip; €0.14/lancet; VAT included). FSL (26 sensors/year; €3.00/day; VAT included) was associated with reductions of 58% in hypoglycemia, 68% in DKA, 83% in the use of strips/lancets, and an absolute decrease of 1.1% in HbA1c. Deterministic and probabilistic sensitivity analyses (SAs) were conducted.</p> Results <p>While SBGM yielded 9.18 quality-adjusted life years (QALYs) and total costs of €77,092 (glucose monitoring = €17,080; diabetic complications = €68,272), FSL yielded 9.98 QALYs and total costs of €61,447 (glucose monitoring = €8820; diabetic complications = €44,367). Compared with SBGM, FSL produced total cost savings of €15,645 and 0.80 additional QALYs per patient, being a dominant alternative compared to SBGM. FSL was found to be dominant in all SAs.</p> Conclusions <p>This analysis suggests that FSL, which provides better clinical outcomes at a lower overall cost, is a preferable alternative to SBGM among people with poorly controlled T2DM on basal insulin.</p>

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Cost–Utility Analysis of FreeStyle Libre Systems in People with Type 2 Diabetes Mellitus on Treatment with Basal Insulin and Poor Glycemic Control in Spain

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年11月7日

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  • Mireya Robles-Plaza,
  • Fernando Gómez-Peralta,
  • Virginia Bellido,
  • Francisco Javier Ampudia-Blasco,
  • Juana Carretero-Gómez,
  • Ana María Cebrián-Cuenca,
  • Alberto de la Cuadra-Grande,
  • Pedro Mezquita-Raya

摘要

Introduction

FreeStyle Libre (FSL) systems are effective and user-friendly glucose monitoring devices. This cost-effectiveness analysis compared FSL vs. self-blood glucose monitoring (SBGM) in patients with poorly controlled [hemoglobin A1c (HbA1c) > 8%] type 2 diabetes (T2DM) on basal insulin, from the Spanish National Health System perspective.

Methods

The DEDUCE model, which simulated 10,000 patients with T2DM over a 50 years’ time horizon (annual discount rate = 3.00%), was adapted to the Spanish setting. The population characteristics, frequency of acute and chronic diabetic complications, costs (€, 2025) and utilities/disutilities proceeded from scientific literature and were validated by national multidisciplinary experts. The annual probabilities of acute events associated with SBGM were 17.02% for non-severe hypoglycemia (SHE) (€3.92; disutility = – 0.0016), 2.50% for SHE (€1031.69; disutility = – 0.0470) and 0.25% for ketoacidosis (DKA) (€2523.93; disutility = – 0.0470). The RECODe risk engine was used to model chronic diabetic complications (myocardial infarction [€1248.44–€31,013.22; disutility = – 0.0550]; heart failure [€1523.14–6505.08; disutility = – 0.1080]; stroke [€3187.92–7849.48; disutility = – 0.1640]; blindness [€2943.37; disutility = – 0.0740]; renal failure [€4057.05–42,757.39; disutility = – 0.2040]). According to the Spanish recommendations, a patient with SBGM required 2.5 reactive strips/day and 2.5 lancets/day (€0.57/strip; €0.14/lancet; VAT included). FSL (26 sensors/year; €3.00/day; VAT included) was associated with reductions of 58% in hypoglycemia, 68% in DKA, 83% in the use of strips/lancets, and an absolute decrease of 1.1% in HbA1c. Deterministic and probabilistic sensitivity analyses (SAs) were conducted.

Results

While SBGM yielded 9.18 quality-adjusted life years (QALYs) and total costs of €77,092 (glucose monitoring = €17,080; diabetic complications = €68,272), FSL yielded 9.98 QALYs and total costs of €61,447 (glucose monitoring = €8820; diabetic complications = €44,367). Compared with SBGM, FSL produced total cost savings of €15,645 and 0.80 additional QALYs per patient, being a dominant alternative compared to SBGM. FSL was found to be dominant in all SAs.

Conclusions

This analysis suggests that FSL, which provides better clinical outcomes at a lower overall cost, is a preferable alternative to SBGM among people with poorly controlled T2DM on basal insulin.