Effectiveness, safety and costs of the FreeStyle Libre glucose monitoring system for children and adolescents with type 1 diabetes in Spain: a prospective, uncontrolled, pre-post study

• Published in: BMJ open Vol. 13; no. 12; p. e071334
• Main Authors: González-Pacheco, Himar, Rivero-Santana, Amado, Ramallo-Fariña, Yolanda, Valcárcel-Nazco, Cristina, Álvarez-Pérez, Yolanda, García-Pérez, Lidia, García-Bello, Miguel Angel, Perestelo-Pérez, Lilisbeth, Serrano-Aguilar, Pedro, Vergaz, Amparo González, Prado Carro, Ana María, Ortego, Anunciación Beisti, Martorell, Ariadna Campos, Carcavilla Urqui, Atilano José, Del Castillo Villaescusa, Cristina Amparo, Poch, Estela Gil, Arroyo Diez, Francisco Javier, Gómez, Gemma Novoa, Casado, Isabel González, Ibáñez, Juncal Martínez, Piqueras, Laura Cuadrado, Iglesias, Leticia Reis, Lorenzo, Lucia Garzón, Fresno, Luis Salamanca, Martínez Brocca, María Asunción, Rodríguez Blanco, María Aurea, Mar Martínez López, María Del, Ferreiro Rodríguez, María Jesús, del Campo, María Ruiz, Martín, Nerea Itza, Navas, Patricia García, García, Rebeca García
• Format: Journal Article
• Language: English
• Published: England British Medical Journal Publishing Group 13-12-2023; BMJ Publishing Group LTD; BMJ Publishing Group
• Series: Original research
• Subjects: Caregivers; Costs; Data collection; Diabetes; Diabetes and Endocrinology; Electronic health records; Glucose monitoring; health economics; Health technology assessment; Hospitals; Hypoglycemia; Information systems; Monitoring systems; paediatric endocrinology; Patients; Pediatrics; Public health; Quality of life; Questionnaires; Self report; Sensors; Teenagers; Spain; paediatric endocrinology; public health; health economics
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2022-071334

ObjectivesThis study aimed to evaluate the effectiveness, safety and costs of FreeStyle Libre (FSL) glucose monitoring system for children and adolescents with type 1 diabetes mellitus (T1DM) in Spain.DesignProspective, multicentre pre-post study.SettingThirteen Spanish public hospitals recruited patients from January 2019 to March 2020, with a 12-month follow-up.Participants156 patients were included.Primary and secondary outcome measuresPrimary: glycated haemoglobin (HbA1c) change. Secondary: severe hypoglycaemic events (self-reported and clinical records), quality of life, diabetes treatment knowledge, treatment satisfaction, adverse events, adherence, sensor usage time and scans. Healthcare resource utilisation was assessed for cost analysis from the National Health System perspective, incorporating direct healthcare costs. Data analysis used mixed regression models with repeated measures. The intervention’s total cost was estimated by multiplying health resource usage with unit costs.ResultsIn the whole sample, HbA1c increased significantly (0.32%; 95% CI 0.10% to 0.55%). In the subgroup with baseline HbA1c≥7.5% (n=88), there was a significant reduction at 3 months (−0.46%; 95% CI −0.69% to −0.23%), 6 months (−0.49%; 95% CI −0.73% to −0.25%) and 12 months (−0.43%; 95% CI −0.68% to –0.19%). Well-controlled patients had a significant 12-month worsening (0.32%; 95% CI 0.18% to 0.47%). Self-reported severe hypoglycaemia significantly decreased compared with the previous year for the whole sample (−0.37; 95% CI −0.62 to –0.11). Quality of life and diabetes treatment knowledge showed no significant differences, but satisfaction increased. Adolescents had lower sensor usage time and scans than children. Reduction in HbA1c was significantly associated with device adherence. No serious adverse effects were observed. Data suggest that use of FSL could reduce healthcare resource use (strips and lancets) and costs related to productivity loss.ConclusionsThe use of FSL in young patients with T1DM was associated with a significant reduction in severe hypoglycaemia, and improved HbA1c levels were seen in patients with poor baseline control. Findings suggest cost savings and productivity gains for caregivers. Causal evidence is limited due to the study design. Further research is needed to confirm results and assess risks, especially for patients with lower baseline HbA1c.