At least in the USA, that would depend on the FDA who are probably not doing anything right now! I had the pleasure of meeting Gil and Jerry @ the DHF event during the ADA Scientific Conference in Chicago and I agree that their product looks very promising.
I don't want to turn this discussion another way, but I need to ask: Why is it a good idea to include glucagon? I do everything possible to avoid it. It makes me throw up, which causes additional problems after my BG goes up--can't keep anything down. In my mind an artificial pancreas should help you avoid going low enough to really need glucagon.
I think it's in the device, which is sort of what I like about it. The only thing that would make me a bit apprehensive would be, as with any piece of gear, what if your phone blows up! Eeek!
Hi Duarte, Thanks for the question.
1. A prototype is a device that performs most of the functions of the real product, but is not fully operational.
2. Every country in the world requires that medical devices must first be tested (on animals and on volunteering humans). After that a company must apply for government approval to start selling it. That takes a lot of time (years) and money (millions).
We need venture capital investment and time before we start selling it.
Cheers,
Gil
Micro doses of glucagon is what will be delivered, if needed. Research proves that: 1. These small amounts do not cause nausea or vomiting on most people (please google for Dr. Ken Ward at OHSU, and Dr. Steven Russell & Dr. Ed Damiano in Boston).
2. After the automatic delivery version is approved, hypoglycemia could be avoided while the user is asleep, for example.
Gil
The only way an artificial pancreas can avoid someone from going low is by delivering glucagon, just like a functioning real pancreas would do. Scenario 1: If you take pre-meal insulin, but then have to skip the meal, for example.
Scenario 2: You exercise, but doesn't want to take glucose tablets nor eat.
The sensor is part of the disposable "GlucoWedge" plug-in module. The transmitter is part of the re-usable "CoreMD" (triangular device at the center). No additional separate devices are needed.
The phone or tablet (and the app) are optional. You may purchase the optional dedicated controller (PDA/Vox). Like with any device, if it gets damaged or lost, you can get a replacement. The advantage of a phone/tablet, over Insulet's PDM for example, is that you can walk into any sote, get a new phone/tablet, download the app, and be ready to use the device again. While some custom PDM or Receiver would require at least 1-2 days to be replaced by the manufacturer.
Does that work for sports? I've been running pretty regularly since 2008 and generally lug some glucose around. A couple of times when I've run low, I've added some anaerobic sprinting in to help the glucose/ dextrose or whatever along and it seems to work pretty well. I've also run some distances and most of the authorities seem to agree that you need some "fuel" for that type of exercise. Perhaps interestingly, the TV announcer at the Chicago Marathon on Sunday noted that the guy who finished second missed his bottle (unk what was in it, I'd *assume* some sort of sports drink, carbs, maybe protein, vitamins, etc.) and then dropped off the pace (2:03, just under 2:04...he didn't drop off that much still...). Could one "eat" or "fuel" with glucagon and then I guess the next question would be how big is the tank? Thanks for your replies in the thread!!
I think we are dealing with a couple of different issues here.
Hypothetically speaking, you could inject small amounts of glucagon in response o a low, but like any dose dependent response, you'd have to work out the proper glucagon/BG ratio and proper doses to get you back to your target BG. That's exactly what the microcomputer on an artificial pancreas would be programmed to do. Personally, I like the idea of eating to restore my glucose levels, but if you an work out the numbers, whatever keeps you going!
People with fully functioning pancreases will be balancing insulin and glucagon secretion to maintain normal BGs through all levels of physical activity.
All physical activity, aerobic or anaerobic, is ultimately glycogen limited whether you're running a marathon or playing hide and seek with your kids. The typical person has around 200g of glycogen stored up in the muscles and liver. Trained athletes can push that up to around 400g while elite distance athletes, like marathon runners, can have 700 to 900g of glycogen reserves at the start of a race.
The reason why any distance athlete consumes anything besides water during a race is because any glucose consumed helps to spare glycogen reserves prolonging physical activity. We've all seen the winner of a marathon gradually drop their competitors, one at a time, during the course of a race. We don't se a whole lot of competitors at the elite level actually "bonk" though. Once you get to that level, you've pretty much worked out your nutritional needs.
When you do see one bonk, though, it means they've pretty much emptied their tank. They've pretty much depleted their glycogen reserves. It's scary...
Gil did you get any transmitters yet ? Or do you still need them. I think my battery is finally dying and I have already called Dexcom for a replacement.
This sounds amazing. I would love to have glucagon so I can go to the gym without planning a couple of hours ahead of time. Not being able to exercise when I want is the hardest thing about being a diabetic for me.
Glucagon is not for energy, stamina, nor better sports performance, i.e. "fuel". It's just to protect people with insulin-dependent diabetes from having hypoglycemia. If you're participating in a long race you would still have to eat/drink during the race, just like everyone else.
Yes. Clinical studies by Dr. Russell and Dr. Damiano in Boston have indicated that it's actually possible to eat or not, or exercise or not, at anytime, just as someone with a functioning pancreas would. Google it and read more about it. :)
But it will be a while before the FDA approves that. ;(
