Bruce Buckingham, MD; Mark Harmel, MPH

Disclosures

July 29, 2016

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Hello. I am Bruce Buckingham. I am a pediatric endocrinologist at Stanford University in California, and I have been involved with continuous glucose monitoring, and now the closed-loop insulin pump, for about 10 years.

It is an amazing time in the field of diabetes, with several groups moving forward with continuous monitoring devices and using that information to adjust insulin doses on a real-time basis, every 5-10 minutes. Thus, at night, when there are no meals or exercise, these new systems allow very good glucose control. People can go to bed with little risk for hypoglycemia during the night, and wake up with glucose levels in the 100-140 mg/dL range almost consistently every morning.

These new devices take the anxieties and worries of the nighttime out of diabetes management. It is a big advance right now and many groups are involved.

Reviewing the Key Players

The group that will probably have the first commercial product is Medtronic, with what they call the 670G pump. This is a basal rate modulator; it modulates the basal insulin throughout the day and night. It still requires the user to give a bolus of insulin before meals and to give correction doses, but it does a great job overnight. It is an integrated system that combines a new Enlite 3 sensor and the Medtronic 670G pump. It is now being submitted to the FDA for approval in 2017.

A group from the University of Virginia also uses a closed-loop system that delivers insulin and, in addition, modulates and will give correction doses automatically throughout the day and overnight. This device does an amazing job with overnight control and helps quite a bit during the day with meals and in keeping glucose levels within range. They are working with a commercial group called Type 0 and are beginning a large pivotal study within the next year.

Roman Hovorka and colleagues in Cambridge, England, have another very good "controlled range" system. This system checks glucose values every 10 minutes and gives corrective doses of insulin, bringing the nighttime glucose levels into excellent control. It also helps with the meals during the day. With 24-hour use over 3 months, this system has been shown to provide an A1c benefit.

Ed Damiano is working with a group in Boston on a pump that uses both insulin and glucagon. As you know, the pancreas secretes insulin and glucagon. Many times in patients with type 1 diabetes, the glucagon is not regulated effectively. This means that when a diabetic eats a meal and requires insulin, the blood sugar level may go down but the pancreas may not be releasing glucagon to prevent hypoglycemia.

This device, an "artificial pancreas," releases glucagon to prevent hypoglycemia. Thus, it allows more aggressive meal coverage. Studies have shown an average glucose in the 146-148 mg/dL range with this device, which is amazing glucose control. At the present time, it requires both insulin and glucagon to be infused. They also have a version of this that uses only the insulin component, which achieves control that is comparable to the other devices that use only insulin.

These scientists have formed a nonprofit corporation called Beta Bionics, and they have created a pilot pump that combines both the insulin and glucagon into small cartridges that go into the pump. Again, this is an integrated system. They are planning to conduct pivotal trials within the next year or so.

One unique aspect of their algorithm is that it does not require carbohydrate counting for the meal bolus. The user can decide whether the carb amount is more or less than usual. The algorithm is adaptive, so each day it is learning the user's basal insulin requirements and the requirements for meals.

I believe this will revolutionize the burden of diabetes.

A group named Bigfoot Biomedical is using the Asante pump and their own algorithm. They will begin clinical trials in the next few months. This group is focused on the total management of diabetes and providing the services and background you need for supplies and support, with the idea of putting all of diabetes management into one place, along with having an excellent basal rate modulator.

I believe that Medtronic will be the first to come forward, followed in the next few years by all of these other companies conducting pivotal trials. We will have a wealth of systems that people can choose from, depending on their needs.

Ultimately, with a faster-acting insulin, we should be able to cover meals so that someone with diabetes could actually be wearing one of these devices, sit down for dinner, and just eat, without entering carbs or having to think about a correction dose, because it would all be done automatically. That will require a faster-acting insulin that comes on and off more quickly, and a number of these insulins are in the pipeline.

I believe this will revolutionize the burden of diabetes. The goal of all of these advances is to reduce the burden so that the diabetic patient can have less concern, less worry overnight, which will be addressed by the first versions, and eventually have the whole day taken care of so that there is no need to think about the amount of carbs being eaten, for the need for a correction dose, or what is going to happen with exercise. That will be taken care of and that will be amazing. I cannot wait.

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