Diabetes Ther. 2025 Nov 07.
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.
Keywords: Basal insulin therapy; Cost-effectiveness analysis; Cost–utility analysis; FreeStyle Libre systems; Glucose monitoring; Poor glycemic control; Self-blood glucose monitoring; Spain; Type 2 diabetes mellitus