An Artificial Pancreas Could Sweeten the Deal for Diabetics

The “artificial pancreas” is making headlines in diabetic communities. People are claiming that it will all but eliminate diabetes from our existence. The JDRF campaign says it will be like becoming a “bionic” diabetic and many groups are hoping it will give more freedom to people living with diabetes.

But what is an “artificial pancreas”? And where do you get one?
The short answer is that the artificial pancreas is a combination of devices and technologies designed to automatically deliver insulin as needed using an insulin pump and a continuous glucose monitor. No surgeries. No extra drugs. As for availability, the US is running far behind other countries and you are most likely to see this system develop in Europe well before the United States at our current rate.

Cartoon illustration of a proposed "artificial pancreas"

The insulin pump is a major component of the system. Insulin pumps are a tremendous tool for diabetes management. Through a small self-applied catheter, an insulin pump delivers fast-acting insulin at a continuous and slow rate. When an extra dose of insulin is needed for a meal or for correction, the wearer simply presses a few buttons to bolus. This method is supposed to more closely mimic a normal pancreas. Insulin pumps tend to improve insulin delivery by being more accurate and with less needles there is less pain and problems. When I started using my pump, I went from 7-9 manual shots a day to only 1 catheter needle every 3-4 days. Even though the pump is worn 24/7, many diabetic users feel like it gives them a higher level of freedom and flexibility.

The pump is widely used and available across the world. Pumps have improved over the years and have started including some pretty nifty features such as tubeless pumps, bolus wizards, and remote controls. But one of the more interesting and recent features is the Continuous Glucose Monitoring (CGM) system. I’ll use Medtronic as an example because that’s the pump I use.

CGM systems also use a small catheter and measure and record blood sugar in real-time using the same technology as in glucometers. When I tried the Medtronic CGM system, I could set it to check my blood sugar every 5 minutes… that’s almost 300 times a day! Even when I’m asleep! With this kind of data, blood sugar trends are clear and quantifiable. Instead of 4-6 points a day, we have 300 or more. CGM illustrates the changes over time, which helps when making decisions about insulin and medication. For instance, a person could observe and treat problems like the “dawn phenomenon” and blood sugar changes caused by illness, exercise, or other medications. Even on a daily basis, CGM can help detect low and high blood sugars before they become a problem.

A PERFECT PAIR 
The artificial pancreas takes the next logical step and connects these two incredible devices with technology and algorithms that allow CGM readings to control insulin delivery. Medtronic already has made steps to make this possible. The Paradigm insulin pump already includes a wireless connection to their CGM transmitter. This way, the CGM data can be viewed in real-time on the screen of the pump. The wearer can see the trends, slopes, as well as individual readings. But the CGM readings do not dictate insulin delivery. Instead of controlling the pump, the readings set off alarms and warnings about rapid changes or extreme lows and highs.

The pairing of pumps and CGM is already available and the alarm system is already included. Over and over again, this setup has been shown to be an incredible management tool. By seeing the rate of change in blood sugar, diabetics can predict what is happening with much better accuracy. People that don’t register low blood sugars or do a lot of heavy exercise now have a helping hand with the alarms. And the common highs and lows of diabetes can be more easily avoided. The pump and CGM combo tends to give diabetics increased freedom and control over their diet and activities. Not to mention, the pump and CGM system reduces the number of needling and poking that a diabetic needs to do on a daily basis.

ROOM FOR IMPROVEMENT 
We’re so close to an artificial pancreas system. We have the real-time measurements from CGM and we have the accurate delivery with the pump. If we could create programs to smoothly predict and control insulin delivery based on the readings, we would have the artificial pancreas.

There are many reasons this would be a great step forward for many pump wearers. First of all, diabetes management could dramatically improve. Predictive algorithms and programs that make the minute mathematical adjustments are exactly the kind of fine-tuning that many diabetics are seeking. Another large market is for diabetic children. Many Type 1 Diabetics are diagnosed in early childhood. At one Walk-A-Thon, I met a mom with a 16 month old baby that was diabetic and another parent with 2 children below the age of 6 with diabetes. In this scenario, diabetes becomes a parent’s full-time job. The angst and fear is also incredibly stressful. On top of the parent’s problems, the life of the child can be dramatically stifled. What about sleepovers or play-dates or afterschool games? If the parent can’t be there, the chances are neither can the child. An artificial pancreas would give more flexibility and relieve some of the constant pressure put on the parent and patient.

The list can go on forever. Diabetics with all kinds of backgrounds could benefit from an artificial pancreas – diabetics that run marathons or exercise a lot or are deaf to alarms or mentally handicapped or physically disabled or starting new medications that may interfere with insulin activity.

HOW FAR AWAY ARE WE? 
Well, there are already over 50 countries using a system that allows CGM readings to control the pump in a single specific scenario. Since 2008, Medtronic has offered the Low Glucose Suspend feature, which suspends the pumps insulin delivery when blood sugar readings drop too low or too fast. Unfortunately the US is not one of those countries.

One of the complaints is that the US is falling behind and leaving the public with the problems and the bills. Money being drained away in Medicare and Medicaid could be saved by preventing downstream diabetic injuries like diabetic kidney disease, retinopathy, nerve damage, and heart disease. Many people believe the artificial pancreas could be a game changer for diabetes management and a life-saver for diabetics.

SO WHAT’S THE HOLD UP? 
Currently, the FDA is waiting for more clinical work to prove that a closed loop system like the artificial pancreas is both safe and feasible. However, waiting for other countries to develop the technology puts the US in a lagging position for medical innovation for diabetes management. The Low Glucose Suspend feature is a first step and the US FDA hasn’t even approved it as a feature. The next logical step is to perfect algorithms and programs that allow the readings from CGM to completely dictate the insulin delivery.

Ideally, the patient would still program boluses for meals and would still need to check blood sugars by finger prick for calibration, but the programs would be able to recognize changes, predict outcomes, and adjust the amount and flow of insulin to prevent lows and correct highs. This would essentially be an external artificial pancreas.

There have already been several clinical studies and more recently outpatient studies using artificial pancreas systems in Europe. The data keeps pouring in suggesting that this is both a helpful and feasible tool for diabetes management. The FDA is well aware of the idea of an artificial pancreas. In 2006, the FDA created the Artificial Pancreas Critical Path Initiative to speed up the process of creating and approving artificial pancreas systems. The chairman, Charles “Chip” Zimliki, is a Type 1 Diabetic himself and believes the FDA’s responsibility is to make sure the product is safe and effective.

Still, many people fear the FDA is dragging its feet. The Low Glucose Suspend feature has been out for almost 4 years in Europe and it is still not approved for the US. Academic research continues, but clinical work on the artificial pancreas in the US is severely lacking compared to work in the UK, Italy, Germany, Canada, and many other industrialized countries. Bluntly, the FDA appears to be a bottleneck for medical innovation.

The artificial pancreas isn’t the only innovation slowed by the FDA approval process. Several disease advocacy groups have campaigned for drugs to be approved for patient use for diseases such as breast cancer, AIDS, and Parkinson’s. The process and bureaucracy involved in the FDA needs to be improved but it should never cost us the safety of patients’ lives. In many ways, the FDA protects the US from unsafe or ineffective drugs and it should continue to do so. However, the counter-argument is that if there are patients that want to try the drug, especially in the case of terminal illnesses, then the FDA is a severely limiting agency.

VOICING YOUR OPINION 
If this is a topic that interests you, there is a website designed by Research!America called Your Congress Your Health. Find out more about your representatives and call or write to them. First, Find your representatives. Then call or write their office and tell them how you feel. Many people have already called their representatives to ask them to hold hearings to urge the FDA to stop the delaying of study and approval of the artificial pancreas.

I personally see the artificial pancreas as a very useful tool in the management of diabetes. It has the potential to give diabetics a greater freedom. At this time, it is just a great possibility, but I hope to see it become a reality. And I hope the US is one of the countries to help bring this innovation to the market.