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The First Artificial Pancreas for Type 1 Diabetes is Approved

POSTED BY: Florida Hospital

Good news for those with type 1 diabetes, also known as juvenile diabetes: The US Food and Drug Administration recently approved the first automated insulin delivery system, which will significantly improve the lives of those with the autoimmune disease.

The Medtronic MiniMed 670G, a so-called "artificial pancreas the size of a cell phone,” is the first of its kind and will help ease the burden of living with this condition.

Type 1 Diabetes

Type 1 diabetes is an autoimmune disease where the body’s immune system attacks part of its own pancreas. The immune system mistakenly sees healthy insulin-producing cells in the body and destroys them. Insulin is a hormone that you need to regulate the amount of glucose in the blood. If you have type 1 diabetes, you need to replace the insulin your body is no longer producing. 

“Type 1 diabetes is a complicated disease,” says Richard Pratley, diabetologist at Florida Hospital. “This new technology can help simplify the management of diabetes while at the same time improving outcomes and safety.”

So, how exactly does it work?

“This device combines a continuous glucose monitor that senses glucose levels every minute and an insulin infusion pump,” Dr. Pratley explains. “The unique aspect of the device is it contains an algorithm that automatically adjusts the insulin infusion based on the glucose levels.”  

This begs the question: What happens when blood glucose levels are too low?

“The device will shut off the insulin infusion, preventing the patient from dropping even lower into unsafe ranges,” says Dr. Pratley.

Without this technology, here’s what a typical day is like for a patient with type 1 diabetes:

  • “Those with type 1 diabetes must measure changes in their glucose levels throughout the day with frequent finger sticks (as many as 10-12 per day) or use continuous glucose monitoring,” says Dr. Pratley.
  • “They then must decide how much insulin is required to correct their glucose levels to the target range. On a meal-to-meal basis, they need to calculate how much insulin is required to "cover" the meal (prevent glucose levels from going out of the target range) and evaluate whether they have adequately covered each meal.”
  • “They need to change their insulin dosing for exercise of vigorous activity. They need to treat low blood sugars with glucose or snacks and reassess how they respond to the intervention.”
  • “Finally, at bedtime they need to make sure they go to sleep in a target range to avoid nocturnal hypoglycemia.”

Hypoglycemia

On top of that, if insulin dosing is too high, this can result in hypoglycemia, which is uncomfortable and can lead to seizures, coma or even death. On the other hand, if insulin dosing is too low, patients will have glucose levels that are unacceptably high, increasing long-term risk for blindness, kidney damage and nerve damage. 

That said, it’s easy to see why patients and physicians are enthusiastic about the new device. “There are still limited clinical trials with this data, but collectively they suggest the device can reduce hypoglycemia and improve overall glucose control in many patients,” he says.

Are there risks to consider?

As far as risks go, one potential risk is that the algorithm might overestimate the insulin requirements and lead to hypoglycemia in extreme conditions. “This risk appears to be low,” he says. “The function of the device is directly related to the quality of the continuous glucose monitoring data which can vary from patient to patient and over time.”

Right now, the FDA approval for this device is for those 14 and older. “Approval for use in younger patients will be contingent on performing the appropriate studies,” he adds. “There’s great interest in this, as managing diabetes in children is challenging and prevention of hypoglycemia particularly important in this population.”

We’re still years away from a biological cure or prevention, however, Dr. Pratley says there are some encouraging studies of stem-cell therapy for patients with established disease and some novel approaches to modulating the pathophysiology (what’s happening in the body to create this condition) of the disease to prevent progression in high-risk individuals.