Continuous glucose monitors (CGMs) are now available over the counter for children aged 2 and older in the United States, marking a significant development in diabetes care accessibility. The Food and Drug Administration (FDA) supports this move, asserting that these devices provide real-time glucose data, enhancing glycemic awareness and aiding in long-term health management for pediatric patients and caregivers.
While the FDA is optimistic, experts are divided on the impact of over-the-counter CGMs for children. Some clinicians believe that collecting more data on children at high risk for diabetes could improve clinical interventions. However, others caution that an excessive focus on data could lead to anxiety and unhealthy eating habits.
Wendy Schofer, a pediatrician specializing in eating disorder prevention, expressed concerns about the premature use of CGMs as a standard of care without adequate guidance on their implementation. She highlighted the lack of sufficient information to help families understand the device’s benefits without causing harm.
CGMs, which monitor blood sugar levels every 15 minutes using a sensor under the skin, are promoted as tools to combat chronic diseases like diabetes and obesity. These conditions, often developing early in life, pose risks for serious health issues if not addressed. Statistics show that 1 in 3 adolescents has prediabetes or type 2 diabetes, and 1 in 5 children is affected by obesity.
Advocates such as Robert F. Kennedy Jr. endorse CGMs for personal health data collection, and the FDA’s approval has opened a new market for companies like Dexcom. This change could attract health-conscious parents who already use CGMs and might extend their use to their children.
The FDA’s approval references a clinical trial involving participants aged 2 and older, suggesting that other companies might seek similar approvals for their CGM devices in the pediatric market.
The opportunities of glucose monitors
The American Academy of Pediatrics has yet to take a formal stance on over-the-counter CGMs for children, but some healthcare professionals express cautious optimism. Kristen Nadeau, a pediatric endocrinologist, views Stelo as potentially more affordable for underserved populations. She notes that high costs and lack of insurance coverage often hinder access to CGMs for children not on insulin therapy, who could benefit from early intervention.
Dexcom claims that its devices can provide glucose insights to families, especially as type 2 diabetes in youth rises. Stelo, unlike prescription CGMs, is available for individuals with diabetes not requiring insulin, as well as those interested in monitoring lifestyle effects on blood glucose.
Stelo is priced at $99 monthly for two 15-day sensors, and its app is free. Julie Wilson, a clinical dietitian, believes that as CGMs become more accessible, they could more effectively influence blood sugar management than traditional educational methods. She highlights that children with obesity, prediabetes, and type 2 diabetes not on insulin, who lack insurance coverage for prescription devices, stand to benefit the most.
Pediatric blood glucose data is limited
Concerns arise over CGM use among children without diabetes, as experts are unsure about the impact. Kristen Nadeau points out that data on normal blood sugar levels for non-diabetic children is limited. She is working on the DISCOVERY trial to address this gap by studying blood glucose through puberty in at-risk children.
The lack of data could make CGM results hard to interpret without clinical guidance. A study found that participants, including children, experienced both low and high blood sugar episodes despite maintaining normal levels most of the time. This variability could lead to overreactions from parents.
Wilson expressed concern about parents restricting foods based on CGM readings, potentially causing children to develop unhealthy relationships with food. She notes that families may need guidance on interpreting data, as cultural and language differences can affect understanding.
Currently, Stelo’s app provides information only for adults. Dexcom has not disclosed plans for pediatric guidance. Laura Burross Jackson, a dietitian, worries that children might focus too much on glucose responses rather than a balanced diet, which is essential for growth.
The risk of disordered eating in children and teens
With eating disorders increasing among young people globally, experts warn that CGMs could exacerbate restrictive eating. The FDA advises consulting healthcare providers for children with a history of eating disorders before using Stelo. However, experts highlight that eating disorders are often underrecognized in the U.S.
Nadeau cautioned that focusing too much on blood sugar variations could contribute to disordered eating patterns. Schofer noted that an obsession with health data could lead to orthorexia in parents, impacting how they feed their children and possibly affecting their mental health.
Schofer also questioned the assumption that all high-risk children would benefit from CGMs, emphasizing the need to consider individual circumstances to avoid harm. She noted that when health becomes just a number, parents might focus more on data than their child’s overall well-being.
