Dr. Weinstock: We hope that this would prevent those unnecessary deaths. Obviously that’s what we all want to do. We want to improve the lives of people with diabetes and ultimately have a cure. The study that we’re participating in is sponsored by Medtronic, the manufacturers of this system. There are also other companies working on other systems and new technologies to form an artificial pancreas as well. So, we’re really excited that this line of research will really help people with diabetes.
Eventually is it the hope that a system will do it all? That it will also sense that your blood sugar is high and give you insulin to correct it?
Dr. Weinstock: Right. That’s what we hope. That’s what we mean by closing the loop. You have a glucose sensor that is sensing your blood sugar every few minutes of every day. You have an accurate insulin pump that is delivering insulin and that they talk to each other and the closed loop means that the pump will know exactly how much insulin to give you so that your blood sugar will stay normal; not go too high, not go too low. That’s something that’s extremely exciting.
What did you hear from patients in your study who used this system?
Dr. Weinstock: One thing that I think surprised us when we were screening for this study and disturbed me honestly, is how many of our patients were having low blood sugars during the night and didn’t realize it. At the beginning when we first looked for volunteers to do this, many of them were wearing a sensor for the first time. We found that they were having prolonged low blood sugars during sleep that we weren’t aware of, which was frightening to them and us. To have a system that can help us first of all detect it and also correct it, is extremely exciting.
So it gives patients extra security?
Dr. Weinstock: Right. We don’t have the data from our study yet .Volunteers for this study were using insulin pump therapy, but in the study get the great benefit of usinga sensor as well.. Some of them had never worn a sensor before, so that was great for them. Participants were randomized to have this low glucose suspend feature turned on or off and the two groups will be compared. We don’t have those data yet for those comparisons for this study. The study is still ongoing and it’s a multi-center study, involving sites across the country.
What’s the end date for that?
Dr. Weinstock: Well, certainly within the next year we should have the results.
So the FDA will need that before approval?
Dr. Weinstock: The FDA will let the sponsor know if they require any additional information.. . I guess we’ll have to wait and find out.
It is approved in other countries?
Dr. Weinstock: Yes. It’s available in Europe. It’s called the Veo Pump system.
There is other research ongoing in many diabetes centers throughout the world.
Some investigators are studying pumps that can dual infuse glucagon and insulin. So if the blood sugar goes too low, not only do you turn down or off insulin, but you can also infuse glucagon. r. There are some additional challenges because stable reconstituted glucagon isn’t commercially available. Glucagon doesn’t come in a vial like insulin, but there are companies working on new ways to manufacture it because they see the value.
Lots of times people will somehow come out of a low and life is fine. But they’re not totally harmless right? If your blood sugar is sitting at 40 for hours, it’s not doing “nothing” to you right? Even if you do wake up and treat it and you’re fine?
Dr. Weinstock: Right. So we don’t really know how low your blood sugar has to go and for how long to cause some damage. Probably it’s different in different people. For someone who is 75 years old who has heart disease, a low blood sugar is probably more dangerous than in a young person with a normal heart. It’s possible that a low blood sugar might cause the heart not to function properly. The same is true for the brain. If someone has vascular disease involving the brain, the brain could be hurt more by hypoglycemia, perhaps affecting cognitive function and even contributing to the development of dementia. The possibility of damage probably depends on both on how low and how long the low sugar episode lasts, individual variations based on age and genetics as well as other medical problems that the individual might have. I think it’s very complicated. I think there’s a lot we need to learn. A lot of research needs to be done, but it’s very gratifying that we’re making progress in a way that can help people.
Do you have any theories on why type 1 is increasing?
Dr. Weinstock: I don’t know, but it’s not just here, it’s across the U.S., Scandinavia, and Europe. People are reporting an increase of three to five percent a year. When I was in medical school, which is a long time ago, the average age of diagnosis, type 1 was around when children hit puberty. Now we’re seeing a lot more very young children and why the age of onset also seems to have fallen in age is something that we don’t really understand.
It’s one of those diseases that you don’t know until you get it. There’s nothing you can do to prevent it?
Dr. Weinstock: Not that we know of right now. There are other studies going on and that are planned to address this. There is a natural history study called Trial-Net, which is screening individuals who have relatives with type 1 diabetes, for autoimmunity; for the antibodies in the blood that are a marker that maybe the body has started to destroy its own insulin-producing cells. Theoretically, if, you still have enough insulin-producing cells that you don’t have diabetes yet, you can you trick the immune system to try to stop that destruction so the diabetes never occurs. It would be wonderful, to have a vaccination someday to prevent type 1 diabetes.
There are some people who have the disease who don’t have that marker right?
Dr. Weinstock: Yes, it’s not 100%. Another approach for curing type 1 diabetes is to regenerate the beta insulin-producing cells. That’s a whole other area of research that’s very exciting.
What is the hygiene hypothesis?