CGM Approval for Children Under Age 2
Yes, the FDA has approved the Dexcom G5 Mobile CGM System for children as young as 2 years of age, but no CGM device is currently approved for children under 2 years old. 1
Current FDA Approval Status
The minimum age for FDA-approved CGM use is 2 years, not younger. 1, 2
- The Dexcom G5 Mobile CGM System received FDA approval in December 2016 for nonadjunctive use (meaning it can replace fingerstick measurements for treatment decisions) in people with diabetes 2 years of age or older. 1
- The American Diabetes Association guidelines from 2018 explicitly state that the FDA approved a CGM device "for ages 2 and older" for making treatment decisions without confirmatory blood glucose monitoring. 3
- Real-time CGM in the U.S. is approved for nonadjunctive use in children aged 2 years and older, while intermittently scanned CGM is approved for children aged 4 years and older. 4
The Gap for Infants and Toddlers Under 2
No CGM device currently has regulatory approval for use in children younger than 2 years of age. 5
- The 2011 Endocrine Society Clinical Practice Guideline made no recommendations for or against the use of real-time CGM by children with type 1 diabetes who are less than 8 years of age, reflecting the lack of evidence and approval in very young children at that time. 6
- Research studies have demonstrated feasibility and parental satisfaction with CGM use in toddlers under age 4, but these were research contexts, not FDA-approved clinical use. 7
- Neonatal studies have shown that CGM can detect clinically silent hypoglycemia in newborns, but current devices are not designed nor have regulatory approval for the specific needs of the newborn population. 5
Clinical Reality vs. Regulatory Status
While the FDA approval threshold is 2 years, real-world CGM use in very young children (ages 2-5 years) has been increasing dramatically, with usage approaching 40% by 2016. 3 However, this increase applies only to children 2 years and older, not infants under 2.
Key Limitations for Very Young Children
Even in the 2-5 year age group where CGM is approved, significant challenges exist that would be magnified in children under 2:
- Painful sensor insertions on small bodies 8
- Wearing multiple devices (sensor and transmitter) on limited body surface area 8
- Skin and adhesive problems in young children 8
- Device size not optimized for infant/toddler anatomy 5
Bottom Line for Clinical Practice
For children under 2 years of age, no CGM device is FDA-approved. If glucose monitoring is needed in this population, traditional blood glucose monitoring remains the standard of care. 3 Any use of CGM in children under 2 would be off-label and should be discussed carefully with families regarding the lack of regulatory approval and limited safety/efficacy data in this age group.