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Published on: February 24, 2023
The neonatal continuous glucose monitoring paradox: why at-risk infants still lack access to a transformative
Alexandra Duncan1, Hannah Burgess2, Kathryn Beardsall2,3
1Clinical School, University of Cambridge, Cambridge Biomedical Campus, Cambridge, United Kingdom.
Insights
Continuous glucose monitoring (CGM) is feasible for newborns but lacks regulatory approval for infants under two. New device designs threaten access for vulnerable infants, highlighting a need for innovation and collaboration.
Area of Science:
- Neonatal care
- Medical device technology
- Neurodevelopmental outcomes
Background:
- Neonatal glucose instability poses significant neurodevelopmental risks, with increasing prevalence due to prematurity and maternal diabetes.
- Continuous glucose monitoring (CGM) has been shown feasible in neonates for over two decades, aiding in detecting glycemic variability and reducing invasive sampling.
- Current CGM use in neonates relies on off-label adult devices, facing insertion challenges and regulatory hurdles.
Purpose of the Study:
- To address the lack of licensed CGM systems for infants under two years of age.
- To highlight the challenges posed by evolving commercial CGM designs for neonatal use.
- To advocate for needs-led innovation and equitable access to medical technologies for high-risk infant populations.
Main Methods:
- Review of existing research on CGM feasibility and application in neonatal populations.
- Analysis of regulatory landscapes and commercial device development trends impacting neonatal CGM.
- Examination of access inequities and innovation barriers for specialized medical devices.
Main Results:
- No CGM system is currently licensed for children under two years old, despite established feasibility.
- Upcoming integrated CGM designs may render current off-label neonatal use unsafe and impractical.
- This situation exemplifies broader challenges in innovation and access for rare disease and high-risk populations.
Conclusions:
- Equitable access to essential technologies like CGM for neonates requires addressing regulatory and commercial barriers.
- Sustained collaboration among clinicians, researchers, regulators, and industry is crucial for driving needs-led innovation.
- Developing specific regulatory frameworks and support for derisking development is essential for high-risk populations.
Abstract:
Glucose instability in the newborn is common, often clinically silent, and carries serious consequences for neurodevelopment. With rising rates of prematurity and maternal diabetes, the number of infants at risk is growing. Two decades of research have established continuous glucose monitoring (CGM) as feasible in neonatal populations, with the potential for detecting previously missed dysglycaemic episodes alongside reducing the need for repeated invasive blood sampling. Despite this no CGM system is licensed for use in children below 2 years of age. Research in neonates has relied on off-label use of devices designed for adults, with challenges of insertion and regulatory barriers to use in clinical practice. Even the current off-license workaround is under threat as the commercial CGM design is moving toward integrated devices that combine sensors and transmitters. This development will make CGM more difficult to use in newborns, and unsafe in extremely preterm infants. Not only is this an example of inequity of access to those with significant clinical need it is also an innovation opportunity. This lack of needs-led innovation is not unique to CGM but is a case study of a broader issue affecting high-risk, and rare-disease populations. In these settings commercial incentives alone usually fall short and support for derisking development is essential. The EU and FDA have begun building regulatory infrastructure to address this. However, ensuring equitable access to innovations in care, of which CGM is just one example, will require sustained collaboration between clinical teams, research funders, regulators, and industry.
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