Senseonics has announced that the first paediatric study participant has been implanted with the Eversense 365-day system as part of the pivotal ENHANCE clinical study.
Senseonics develops and manufactures long-term, implantable continuous glucose monitoring (CGM) systems for diabetes patients.
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By GlobalDataThe insertion in the first patient was performed at the AMCR Institute in Escondido, California, US, under the guidance of Dr Timothy Bailey – the head of the AMCR Institute.
In a statement, Bailey said: “We believe having additional accurate and especially long-term-wear CGM options for our paediatric patients and their families will increase utilisation of the technology and improve the quality of their lives.”
The ENHANCE study will evaluate the accuracy and safety of the Eversense system for up to one year.
The company received an investigational device exemption approval from the US Food and Drug Administration to expand the trial to include paediatric patients aged between 14 and 18 years.
More than 165 adult subjects have been implanted with Eversense systems in four centres across the US.
Enrolment of patients for the 365-day sensor configuration was concluded in September last year. The last patient is anticipated to complete the 365-day visit during the third quarter of this year.
The company will use the data from the study to submit for the integrated continuous glucose monitoring designation this year.
Senseonics chief medical officer Francine Kaufman said: “The differentiated features of our long-term implantable Eversense system are uniquely suited to benefit paediatrics and enable parents and their children to work together to manage diabetes.”
