COMMENTARY

The First FDA-Approved Artificial Pancreas System

Anne L. Peters, MD

Disclosures

January 11, 2017

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Hi. Today I'm going to tell you about some of the most exciting news in the field of type 1 diabetes that we've had in a long time. This is the approval by the US Food and Drug Administration of what many would call the first artificial pancreas system. I am saying "artificial pancreas" because that is the terminology that many people use when describing this, but what we are actually talking about is a hybrid closed-loop system. I am going to explain to you what this means, how it works, how it helps patients, and some of its limitations.

First of all, you have to understand the components of this system. Many of you are probably familiar with an insulin pump. I am going to hold these up so you can see them. This is an insulin pump. It is actually the newest model of an insulin pump that is going to be used in this system. The pump is basically a box, and inside that box we have programmed basal rates and bolus doses. We basically give the pump numbers so that when a person puts in their blood sugar level and how many carbohydrates they are eating, the pump can calculate a dose. Insulin is inserted into the pump in a reservoir. This tubing connects to the infusion set that the patient has stuck under their skin, and then these two are connected. Now there is a fine trickle of insulin that is going in from the pump. It is infusing insulin constantly, with doses being given before meals and when the blood sugar level is too high. We have had these on the market for a long while and they are very useful in the treatment of diabetes, but they require the patient to input the blood sugar levels before each time they eat. This can either be directly sent in through the meter or manually put in.

More recently, we've developed a technology called continuous glucose sensing. This is another externally worn device with a sensor inserted under the skin and a transmitter attached to the sensor. Every 5 minutes, an interstitial glucose level is sent somewhere. In the case of this pump, it is sent to the pump. It can also be sent to your iPhone. It can be sent to any of the receivers that will receive the signal. The beauty of the continuous glucose monitor is that it can alert patients when their blood sugars are too high or too low so that the patient can do something to correct the situation.

Until now, the pump was just a receiver for glucose levels. There was a model of this pump that would suspend if the blood sugar levels got too low, but that was only the first step. Now there is integration between the sensor data and the pump. The pump has a control algorithm. Inside the pump, it looks at the sensor blood sugars as they go up and down, and the pump can go up and down in terms of the insulin it is giving the patient. Now the patient doesn't have to be thinking every moment about what their blood sugar level is. The pump is, in essence, thinking for the patient. It is very nice at keeping blood sugar levels steady, particular overnight or during periods when the patient is not eating. It takes some of the thought process away from the patient and automates it. You might think that this would be a simple thing to do, but I can tell you that many very smart people have been working on this for years, and this is the first time it has actually come to market. This system will be available in the spring of 2017 for limited distribution, and then wider distribution in the months and years to come.

This is the first in class. There are going to be many other similar systems that come out. One of the problems with this specific system is that it doesn't know when a person is going to eat. It doesn't intuit how much food the person will eat, so people are still going to have to enter how many carbohydrates they are going to eat so that the pump can give them an appropriate pre-meal dose. A person does have to interact with this system and is going to have to do some adjusting for meals. It is still a leap forward in terms of the pump and sensor communicating so that the pump can maintain normal basal levels of glucose and help people avoid having frequent low blood sugar levels, as well as having frequent high blood sugar levels.

I am going to tell you some of the downsides of this as well. First of all, in the world of technology, it's the user that makes the most difference. I have patients with good control on insulin pumps and bad control on insulin pumps, and patients with good control on injections and patients with less good control on injections, because the person has to be willing to interact with the disease. Patients have to do the steps that are required. The thing that has really revolutionized diabetes care for most of my patients is the continuous glucose sensor, because whether you are on injections or on a pump, having that additional continuous information about blood sugar levels really helps you make treatment decisions and helps you avoid having frequent low blood sugar reactions. Remember that, in people with type 1 diabetes, it is a hard balance between being too high and too low to keep themselves in a normal healthy range as they live their lives.

An external challenge about devices is that they are subject to all sorts of issues that devices can have. Patients can have infusion set issues, they can get an infection, they can get a clog, or they can get a kink. My patients who are on insulin pumps have to do a fair amount of troubleshooting. This is not the sort of thing you stick on and forget about. It's something that requires the patient to interact with it. It's important to be realistic here; this is not something that we are going to be able to put on every person and expect to have completely normal blood sugar control, but I consider it an incredible step forward for many of our patients with type 1 diabetes.

There are a couple of other caveats that I would like to address. First of all, I don't push any technology on any patient. I like to give my patients options. The newer basal insulins can give very steady overnight blood sugar levels for my adult patients with type 1 diabetes. For many of them, just having a sensor is adequate. They may not need or want to have a pump. If somebody has really good control without an insulin pump, that's fine, but I have many other patients who prefer using an insulin pump. They consider it more convenient. Those individuals should have access to this.

Unfortunately, Medicare and Medicaid do not pay for glucose sensors, which is going to be a big problem for our patients who need this system the most. For instance, our older patients who have more brittle blood sugar levels may really benefit from a system such as this, but so far, we are not able to get sensors covered for them. I really urge you to advocate for getting sensors covered for our older patients and our poorer patients so that they, too, can have access to technology that can change their life, whether it is a sensor alone or a sensor combined with a pump.

This hybrid closed-loop system is the beginning of a wonderful series of advancements in our treatment of type 1 diabetes, and I am very excited to be able to share this with you. Thank you.

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