Blood glucose monitoring devices for type 1 diabetes: a journey from the food and drug administration approval to market availability.

Blood glucose monitoring constitutes a pivotal element in the clinical management of Type 1 diabetes (T1D), a globally escalating metabolic disorder. Continuous glucose monitoring (CGM) devices have demonstrated efficacy in optimizing glycemic control, mitigating adverse health outcomes, and augmenting the overall quality of life for individuals afflicted with T1D. Recent progress in the field encompasses the refinement of electrochemical sensors, which enhances the effectiveness of blood glucose monitoring. This progress empowers patients to assume greater control over their health, alleviating the burdens associated with their condition, and contributing to the overall alleviation of the healthcare system. The introduction of novel medical devices, whether derived from existing prototypes or originating as innovative creations, necessitates adherence to a rigorous approval process regulated by the Food and Drug Administration (FDA). Diverse device classifications, stratified by their associated risks, dictate distinct approval pathways, each characterized by varying timelines. This review underscores recent advancements in blood glucose monitoring devices primarily based on electrochemical sensors and elucidates their regulatory journey towards FDA approval. The advent of innovative, non-invasive blood glucose monitoring devices holds promise for maintaining stringent glycemic control, thereby preventing T1D-associated comorbidities, and extending the life expectancy of affected individuals.

Hemangiomatosis neonatal difusa / Diffuse neonatal hemangiomatosis

Introducción. La hemangiomatosis neonatal difusa es una entidad poco frecuente. Es un trastorno grave en el que aparecen múltiples hemangiomas cutáneos y viscerales de distribución amplia y, en ocasiones, puede ser fatal. Las complicaciones incluyen falla cardiaca, hemorragias, falla hepática, entre otras. El tratamiento está encaminado a evitar los efectos adversos y las complicaciones. Caso clínico. Se trata de un paciente masculino de 53 días de vida que acudió al hospital por presentar lesiones cutáneas y sangrado de tubo digestivo alto. Durante su internamiento se encontraron hemangiomas viscerales en pulmón, bazo y mucosa gástrica. Recibió tratamiento con interferón alfa-2b y corticosteroides. Los hemangiomas de mucosa gástrica fueron coagulados con argón plasma. Conclusiones. La hemangiomatosis neonatal diseminada es una entidad rara que puede ser mortal si no recibe tratamiento. El paciente evolucionó satisfactoriamente y actualmente se encuentra asintomático.

Introduction. Diffuse neonatal hemangiomatosis is a rare entity and is a serious disorder in which multiple cutaneous and visceral hemangiomas are widely distributed and sometimes may be fatal. Complications include heart failure, bleeding, and liver failure, among others. Treatment is aimed at avoiding adverse effects and complications. Case report. We report the case of a 53-day-old male patient who presented to the hospital for skin lesions and upper gastrointestinal bleeding. During his hospital stay, visceral hemangiomas were found in the lung, spleen and gastric mucosa. He was treated with interferon alpha-2b corticosteroids and hemangiomas of gastric mucosa were treated with argon plasma coagulation. Conclusions. Disseminated neonatal hemangiomatosis is a rare entity and can be fatal if untreated. Our patient experienced a satisfactory evolution and is currently asymptomatic.