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Entrega de insulina en circuito cerrado en la diabetes tipo 1 controlada de forma subóptima: ensayo multicéntrico
Martin Tauschmann1, Hood Thabit2, Lia Bally3
1Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK; Department of Paediatrics, University of Cambridge, Cambridge, UK.
Lancet (London, England)
|October 8, 2018
Resumen
La administración de insulina de ciclo cerrado híbrido mejoró significativamente el control de la glucosa en pacientes con diabetes tipo 1. Este sistema avanzado redujo el tiempo dedicado a la hiperglucemia e hipoglucemia en comparación con la terapia de bomba aumentada por sensores.
Área de la Ciencia:
- Endocrinología
- Ingeniería biomédica
- Investigación clínica
Sus antecedentes:
- El control glucémico es un desafío persistente para las personas con diabetes tipo 1.
- El control glucémico subóptimo aumenta el riesgo de complicaciones de la diabetes a largo plazo.
Objetivo del estudio:
- Evaluar la eficacia de la administración de insulina en circuito cerrado híbrido (HCL) frente a la terapia con bomba aumentada por sensores (SAP).
- Evaluar el impacto de la terapia con HCL en el control glucémico en pacientes con DT1 con control subóptimo.
Principales métodos:
- Un ensayo controlado aleatorio abierto, multicéntrico, multinacional y paralelo.
- Los participantes (mayores de 6 años) con DT1 y HbA1c de 7.5- 10.0% fueron asignados al azar a tratamiento con HCL o SAP durante 12 semanas.
- Endpoint primario: tiempo en el rango objetivo de glucosa (3,9- 10,0 mmol/ L) a las 12 semanas.
Principales resultados:
- El tratamiento con HCL aumentó significativamente el tiempo en el rango de glucosa objetivo (65% vs 54%, p< 0, 0001).
- El tratamiento con HCL condujo a una mayor reducción de la HbA1c en comparación con el SAP (diferencia del 0,36%, p< 0,0001).
- Se observó una reducción del tiempo en hipoglucemia e hiperglucemia con el tratamiento con HCL; no hubo diferencias significativas en la dosis de insulina ni en el peso corporal.
Conclusiones:
- La administración de insulina de ciclo cerrado híbrido es eficaz para mejorar el control de la glucosa en la diabetes tipo 1.
- El tratamiento con HCL reduce el riesgo de hipoglucemia y aumenta el tiempo en el rango objetivo de glucosa en pacientes con control subóptimo.
- Esta tecnología ofrece un avance prometedor para el manejo de la diabetes tipo 1 en varios grupos de edad.
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