FDA approves artificial pancreas for young children with type 1 diabetes
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The FDA approved a next-generation hybrid closed-loop insulin delivery system for children aged 2 to 6 years with type 1 diabetes, according to an agency press release.
The MiniMed 770G system (Medtronic) is a hybrid closed-loop diabetes management device intended to automatically monitor glucose and provide appropriate basal insulin doses with little or no input from users or their caregivers. The 770G system is the first legally marketed device that can automatically adjust insulin delivery based on continuous glucose monitor values for a young pediatric population.
“Advancements in science, technology and manufacturing have helped make great strides in the treatment and successful management of type 1 diabetes, a life-threatening chronic condition,” Stephen M. Hahn, MD, FDA commissioner, said in the release. “The FDA is dedicated to promoting policies that support the development of new technologies based on these advances and remains committed to helping ensure that development and expansion of products that can improve the quality of life for those with this condition —which can particularly impact children — is safe and effective.”
The 770G system is a Bluetooth-enabled version of the previously approved MiniMed 670G system and works by measuring glucose levels in the body every 5 minutes and automatically adjusting insulin delivery by either administering or withholding insulin. The system includes a glucose sensor, an insulin pump and an infusion patch connected to the pump with a catheter that delivers insulin. Users need to manually request insulin doses to counter carbohydrate consumption at mealtime.
The FDA evaluated data from a clinical trial that included 46 children aged 2 to 6 years with type 1 diabetes. Study participants wore the device for approximately 3 months to evaluate the performance of the device during at-home periods, as well as a hotel period, to stress the system with sustained daily exercise. That study found no serious adverse events and concluded that the device is safe for use. Data from that study were used to help support the expanded indication for children aged 2 to 6 years.
Risks associated with use of the system may include hypoglycemia and hyperglycemia, as well as skin irritation or redness around the device’s infusion patch. As part of this approval, the FDA is requiring the device manufacturer to conduct a post-market study to evaluate device performance in real-world settings among children aged 2 to 6 years.
This device is not approved for use by children younger than 2 years old or by individuals who require less than 8 units of insulin per day.
"We’re thrilled to be launching this new system as we understand how important these data sharing features are, particularly right now — with many individuals and families opting to see their doctors virtually via telehealth visits," Sean Salmon, executive vice president and president of the diabetes group at Medtronic, said in a press release. "As a parent, I understand very personally why connectivity is so important, and I’m pleased we’ll be able to broaden access to hybrid closed-loop therapy with the additional peace of mind caregivers need to ensure the well-being of their loved ones. This latest launch underscores my personal commitment to making life easier for people living with diabetes through the technologies we deliver.”
Perspective
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Laura M. Nally, MD, FAAP
Until the most recent approval of the Medtronic MiniMed 770G hybrid closed-loop system, there was no FDA-approved device for children aged 6 years or younger with type 1 diabetes. However, children between ages 2 and 6 years have unique challenges to managing type 1 diabetes; they often have unpredictable eating habits and spontaneous activity, and they may not be able to recognize and communicate symptoms of hypoglycemia and hyperglycemia to caregivers. Allowing for younger children to have access to automated insulin delivery is likely to lessen severe hypoglycemia and hyperglycemia and improve time spent within the target glucose ranges.
It is known that real-time continuous glucose monitors that allow for remote monitoring lessen parental fear of hypoglycemia and improve parental health-related quality of life, family functioning, stress, anxiety and sleep for parents of children with type 1 diabetes. Thus, with the addition a smart phone application allowing for diabetes data to be transferred passively in real-time, parents and caregivers of young children with type 1 diabetes will have immediate access to sensor glucose trends and insulin doses, which will translate to improved peace of mind when their child is away from home. Further, while the device itself is able to modify the amount of insulin that the child receives to reduce hypoglycemia and hyperglycemia, the smartphone application allows for a second layer of safety by alerting caregivers remotely if the child is sleeping and develops unanticipated hypoglycemia or hyperglycemia.
As with any new technology, it is important to set realistic expectations with families and have frank conversations about the potential risks and benefits for each patient.
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