Managing diabetes in children is a round-the-clock enterprise that soon may become less worrisome for parents with the introduction of a device popularly called an artificial pancreas.
Formally known as the MiniMed 670G system, the device was developed by the Minnesota medical device company Medtronic, and was approved by the U.S. Food and Drug Administration last summer.
It is designed for people with Type 1 diabetes, the form of the disease in which the pancreas produces little or no insulin — the hormone that controls blood sugar, also known as glucose. Type 1 diabetics have to be provided with insulin either through daily injections or a conventional pump.
Unlike older devices, the new system functions as a pump and continuous glucose monitor, keeping blood sugar in a normal range via embedded electronic intelligence.
By automatically monitoring glucose every five minutes and correcting imbalances, the MiniMed system reduces the risk of life-threatening diabetic episodes. Parents of youngsters with Type 1 diabetes have long interrupted their children at night as they slept to test blood sugar, which naturally drops during slumber. Children using the device can safely sleep through the night.
“It is finally being rolled out to pediatric patients,” said Dr. Jennifer Osipoff, a pediatric endocrinologist at Stony Brook Children’s Hospital. “Adult patients started receiving it in the middle of April. But now, at long last, our pediatric patients will be receiving it as part of our priority access program.”
The system consists of a tiny sensor with an attached needle that is placed under the skin to continually monitor glucose. Another key component is the pump, usually worn near the abdomen. This portion has tubing to deliver insulin.
Osipoff calls it a closed-loop system because it is both a pump and a monitor. Some doctors — and numerous patients — call it an artificial pancreas because its level of sophistication mimics functions of the human organ.
Although the MiniMed system — estimated to cost between $6,000 and $8,000, not including expenses for the disposable sensors — was approved by the FDA for teens 14 and older, doctors are allowed to prescribe the device “off-label,” which in this instance means using it for age groups not included in regulators’ final approval.
Type 1 diabetes usually is diagnosed in childhood, hence its original name, juvenile diabetes.
“My youngest patient who is on a [conventional] insulin pump is 19 months old, and my youngest patient ever was 7 months old,” Osipoff said.
She said she will prescribe the device off-label because it is vital to effectively control blood sugar as early as possible in children with Type 1 diabetes. Elevated glucose can lead to organ damage, blindness and amputations. Blood sugar that is too low can trigger unconsciousness, Osipoff said.
Her first patient to soon start using the MiniMed system is 5-year-old Nadia McKee of East Setauket.
Nadia and her parents, Daniela and Robert McKee, attended a recent Technology Night sponsored by Stony Brook and JDRF, a juvenile diabetes foundation, which introduced families to the MiniMed system.
“Nadia will be starting it in about a week,” Daniela McKee said Friday. “In our conversations with the doctor, we’ve learned how it works and we are very excited about it because this machine means a longer and healthier life.
“What this will provide is the next step,” the mother said. “It will monitor her sugar itself, which is incredible.”
She said Nadia, though very young, understands the need for technology in her life and already has worn a conventional insulin pump.
“Children who are battling a chronic disease would surprise you with what they understand,” McKee said. “She understands, in a 5-year-old’s terms, that her pancreas doesn’t work and that we have to provide her with these machines to do what her body cannot.”
Robert McKee said he is not fazed by the off-label usage. “The pump she is on now is in the same [off-label] category,” he said. “That’s what the FDA does.”
He also is excited that his daughter, who starts kindergarten in the fall, is a medical pioneer.
“She is the first pediatric patient,” he said. “That’s why this is a big deal.”