FDA: Diabetes device plan may help patients faster

Reuters) – The U.S. Food and Drug Administration issued new guidelines on Thursday for the development of a potentially revolutionary device to treat type 1 diabetes that will give manufacturers ‘maximum flexibility’ in getting it to U.S. patients.

The guidelines reflect months of behind-the-scenes negotiations with patient advocates, medical device makers and researchers working to develop an artificial pancreas — a complex system of pumps and sensors aimed at automating the care and treatment of type 1 diabetes.

It is not yet clear if they will appease concerns that the FDA would set the bar too high, making regulations so cumbersome that it would delay access of these potentially revolutionary devices to diabetics in the United States.

“This guidance was developed in a way to account for innovation,” Charles “Chip” Zimliki, who heads an FDA initiative to speed up availability of an artificial pancreas, told Reuters in a telephone interview.

Zimliki said the new draft guidance gives researchers and medical device makers clear guidelines for approving clinical trials that can prove these devices are safe in real-world outpatient settings.

“I think we’re doing a really good job at getting these clinical studies going and we’re showing them a path that I think can get them to a safe and effective product in the U.S.,” he said.

Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement the new guidance will “provide maximum flexibility to manufacturers seeking to bring this device to U.S. patients.”

“We understand how this device could change the lives of millions of Americans with diabetes, and we want our safety and effectiveness review to give patients the confidence that the device works,” Shuren said.

Zimliki says the guidelines take into account concerns raised over guidelines for a very early version of an artificial pancreas device, known as a low glucose suspend device.

Those devices involve a safety feature built into an insulin pump that shuts off the pump when a diabetic’s blood sugar falls to dangerously low levels.


The new guidelines are focused on more complex artificial pancreas devices that would automate many of the tasks a diabetic must do to manage their disease.

These systems are made up of medical devices worn outside of the body to take over for insulin-making cells in the pancreas, which become destroyed in people with type 1 diabetes.

The systems combine two medical devices, an insulin pump and a continuous glucose monitor or CGM that receives information on glucose levels from a sensor placed under the patient’s skin.

The pump and CGM work together, monitoring the body’s glucose levels and automatically pumping appropriate doses of insulin as determined by a computer algorithm.

These systems are meant to manage dangerous spikes and valleys in blood sugar that occur as diabetics try to manage the disease by checking their blood sugar and injecting themselves with insulin.

The FDA guidance document recommends a three-phase clinical trial progression leading to outpatient clinical trials.

And it suggests ways researchers can use existing safety and effectiveness data for various components that make up the system, including data gathered from clinical studies conducted outside of the U.S.

When final, the guidance will help manufacturers and investigators assemble submissions for clinical trials as well as product approval submissions.

The devices are aimed at treating the 3 million Americans with type 1 diabetes, an autoimmune disease in which the immune system destroys cells in the pancreas that make insulin.

Formerly called juvenile diabetes, type 1 diabetes is less common than type 2 diabetes, the form of the disease linked to obesity and lack of exercise that affects 26 million people in the United States.

People with type 1 diabetes currently must monitor their blood sugar and take insulin several times a day to regulate it and prevent diabetic complications, which include heart and kidney disease.


Technology advances ease personal diabetes care

Insulin pumps, patch pumps, continuous glucose monitors can help you manage diabetes.

By Laura Isensee


Insulin pumps, insulin pens and blood sugar monitors. Those are some of the latest devices that can make it easier for the millions of people with diabetes to manage the disease.

But even as new technologies take hold — and even more are on the horizon — it means patients need to be smart, educated consumers to choose the device that works for them.

“There has been an explosion of available medications, technologies and glucose-health tracking tools available for people living with diabetes. It is therefore important that consumers be mindful and research what is available and ensure that all major diabetes management decisions are discussed with the individual’s health care team,” said Kellie Rodriguez, director of education services at the Diabetes Research Institute, University of Miami.

Another resource, offered by the American Diabetes Association: an annual consumers guide.

No matter the technology, consulting with a certified diabetes educator and training is crucial, said Lois Exelbert, a board member for the local American Diabetes Association and director of the diabetes center at Baptist Hospital.

“Somebody who goes on a pump without the proper education risks dangerous consequences,” she said. “They can have a kink in the pump and not know it, or they can miscalculate a dose if they are not properly informed.”

With that caveat, here are some options to review with your doctor and diabetes educator.


New ‘smart’ pumps form the cornerstone of technological advancement, Rodriguez said. They provide the closest tool to replicate how our bodies deliver insulin. There are currently four on the market:

•  Omnipod by Insulet;

•  One Touch Ping by Animas / Johnson & Johnson;

•  Revel by Medtronic; and

•  Spirit by Roche.

All have similar options to deliver insulin: calculators, the ability to vary the amount of basal, or baseline, insulin, and delayed injections. Some have additional features. For example, the Omnipod offers a tubeless pump; the One Touch Ping has a remote insulin calculation and delivery and personalized food diary; and the Revel combines the pump with continuous glucose monitor capabilities.

In the future, there could be pumps that automatically shut off if someone has hypoglycemia, Rodriguez said. The ultimate goal: incorporate a patch pump to detect glucose and respond to changes — independent of the patient.

For Astrid Matthysse, who uses the One Touch Ping, the elimination of injections wasn’t the most important change. “Just the freedom I have with the pump — an easier lifestyle,” she said. Matthysse, 51 and the mom of two college kids, keeps a busy schedule. She works as a clinical manager for Animas and is earning a master’s degree in international business.

“When I was on injections, I had to stop to eat, otherwise my blood sugar would drop too low. Now with the pump, I can eat whenever I want and my blood sugar will not be affected,” she said.


These offer another method to deliver insulin. They have an insulin reservoir, delivery system and cannula — an insertion device — all built into a small, wearable device that is disposable or semi disposable.

“Patch pumps simplify traditional insulin pump therapy — essentially they are tube-free pumps,” Rodriguez said. Insulet’s Omnipod is available in the United States. A new patch is on the horizon for 2012: the V-Go, a fully disposable device to deliver basal and bolus insulin for adults.

Rodriguez said some of the benefits are that they are easier to use because there are no tubes; training is simplified; and the up-front costs are lower.


Continuous glucose monitors (CGMs) can give nearly 300 glucose readings in 24 hours; provide trending information, which is especially valuable overnight and after a meal.

Exelbert said continuous monitors are a key instrument for people whose blood sugar fluctuates a lot. Even if not used permanently, Exelbert said the continuous monitor can be used for a week as a diagnostic tool.

The benefit: more blood sugar readings and information if the level is headed down or up, she said. If someone tests their glucose every two hours, “what’s still missing in between is what happens to blood sugar and you don’t know if blood sugar is on the way up or down,” Exelbert said. “But by wearing a continuous glucose monitor you’re getting readings every five minutes and it’s telling you if it’s trending up or down.”

There are four continuous glucose monitor systems available on the market: DexCom; Guardian by Medtronic; I-Pro, and the Paradigm/Revel Insulin Pump sensor combination by Medtronic.

Della Matheson, a registered nurse and research coordinator at the Diabetes Research Institute, University of Miami, said she used to stick her finger eight to 10 times a day. With her continuous sensor — she uses DexCom — she can get a reading every five minutes.

“It gives me more information so I can anticipate where I’m headed and what I’m going to do behaviorally,” she said. “It [sounds an] alarm if you go below or above your target – it’s a hypoglycemia alert system.”


People with diabetes can find both disposable and non-disposable insulin pens. The needles have become smaller and companies have made their own advances. For example, Lilly’s pen, called the Memoire, provides a reminder of when the last bolus of insulin was delivered and how much.

Matheson said the pens are more convenient. “You can carry them in your purse or your pocket, it makes it easier to take your insulin on the go,” she said.