دورية أكاديمية
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
| العنوان: | 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 |
|---|---|
| المؤلفون: | 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, The Health Professional Group, 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 |
| بيانات النشر: | BMJ Publishing Group Ltd |
| سنة النشر: | 2023 |
| المجموعة: | HighWire Press (Stanford University) |
| مصطلحات موضوعية: | Diabetes and endocrinology |
| الوصف: | Objectives This 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. Design Prospective, multicentre pre-post study. Setting Thirteen Spanish public hospitals recruited patients from January 2019 to March 2020, with a 12-month follow-up. Participants 156 patients were included. Primary and secondary outcome measures Primary: 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. Results In 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. Conclusions The use of FSL in young patients with T1DM was ... |
| نوع الوثيقة: | text |
| وصف الملف: | text/html |
| اللغة: | English |
| العلاقة: | http://bmjopen.bmj.com/cgi/content/short/13/12/e071334Test; http://dx.doi.org/10.1136/bmjopen-2022-071334Test |
| DOI: | 10.1136/bmjopen-2022-071334 |
| الإتاحة: | https://doi.org/10.1136/bmjopen-2022-071334Test http://bmjopen.bmj.com/cgi/content/short/13/12/e071334Test |
| حقوق: | Copyright (C) 2023, British Medical Journal Publishing Group |
| رقم الانضمام: | edsbas.53DE0421 |
| قاعدة البيانات: | BASE |
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Design Prospective, multicentre pre-post study. Setting Thirteen Spanish public hospitals recruited patients from January 2019 to March 2020, with a 12-month follow-up. Participants 156 patients were included. Primary and secondary outcome measures Primary: 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. Results In the whole sample, HbA1c increased significantly (0.32%; 95% CI 0.10% to 0.55%). 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