A New Device Approved by the FDA Could Radically Change the Lives of Diabetics

The life of a type-1 diabetes patient is not easy. The disease affects every minute of your existence and can reduce your life expectancy by as much as 15 years. “I would have to check my blood glucose at least five times a day and stick myself with needles at least four times a day,” wrote one sufferer.

A new device might change such patients’ lives radically. On Sept. 28, after years under development and testing, the US Food and Drug Administration approved the first automated insulin-delivery device. It’s a step closer to giving type-1 diabetes patients an artificial pancreas.

Type-1 diabetes is caused when the body mistakenly destroys its own insulin-producing cells. Insulin is needed to regulate the level of glucose in the blood, and without natural insulin, patients have to inject synthetic insulin to ensure the body keeps functioning. Too much or too little glucose in the blood can damage the organs and even cause death.

MiniMed 670G is manufactured by the medical devices company Medtronic. It consists of a glucose monitor and an insulin pump, connected to a catheter inserted under the skin. The pump is governed by a computer algorithm that, based on glucose levels and how many calories of food a person eats at various times of the day (which has to be entered manually), figures out how much insulin is needed to keep the glucose level under control.

“People who have participated in artificial pancreas clinical trials have not only attained better overall [blood sugar] control, but have experienced the relief of sleeping through the night and waking up in the morning with blood glucose levels within target range,” Aaron Kowalski, chief mission officer for JDRF (formerly the Juvenile Diabetes Research Foundation), told CBS News. A number of such devices are currently under clinical trials and could be available within the next few years.

Though it’s been called an “artificial pancreas,” the device doesn’t really meet that description, because users still have to tell it their daily calorie intake. Moreover, the catheter needs to be reinserted every three days in a different place, otherwise scar tissue builds up, which can impede the absorption of insulin. Yet some believe that it may be the biggest leap in improving the lives of diabetes patients since insulin therapy was developed in the 1920s.

Though Medtronic hasn’t released a price yet, it’s unlikely the device will be cheap. Its 530G model, which also delivers insulin automatically but has a much more rudimentary glucose monitor, costs more than $7,000. Though some American insurance providers provide cover for such costs, there’s still typically a steep deductible.

The device will be available in the market early next year, but only for patients 14 and older. Medtronic is now conducting a trial for younger patients.