5 ms·

FDA approves Medtronic's 'artificial pancreas' for diabetes

64 points by helloworld 10y ago

andrewtbham 10y ago
In the 90s minimed brought insulin pumps to market. It was one of the first stock I ever bought and it blew up. They regularly wrote about their primary goal of creating an artificial pancreas. Eventually they were bought by Medtronic and I sold my shares. Glad to see they are finally achieving their long term goal... nearly 20 years later.
elmin 10y ago
Can someone explain why notifying the device of exercise and eating is necessary? Is it because 5 minutes is too low of an interval, or because the glucose sensor is slow, or because the body relies on other eating and exercise cues to regulate insulin.
- cperciva 10y ago
  The sensors aren't perfectly accurate; I don't know about the newer sensors which this closed-loop system uses, but the current generation only fulfills the accuracy requirements by reporting the median of 7 consecutive every-5-minutes measurements and carrying a warning of "don't trust these values if you have reason to think that your blood glucose might be changing rapidly". My guess is that providing notifications of exercise and food (aka. "I expect my blood glucose to go (down|up) right now") allows the model to be tuned to respond more aggressively to new data at some times and less aggressively at others. (The "less aggressively" side is probably most important: If the sensor suddenly reports a dramatic change in blood glucose in the middle of the night, the system should probably respond with "HEY WAKE UP THE SENSOR IS BROKEN" rather than "let's kill the patient".)
  - shanselman 10y ago
    Exactly. Not to mention they are testing interstitial fluid and not whole blood, which introduces significant delays.
    - cperciva 10y ago
      I've found that the interstitial delay is pretty minimal; maybe 5-10 minutes behind fingerpricks (which themselves lag somewhat behind arterial blood, especially if your hands are cold). The dominating factor is the 15-20 minutes it takes before the median of a window reflects the new data.
      - shanselman 10y ago
        Sure, but we agree every minute counts. Also, CGMs in arms differ from belly, etc. 10 min when insulin starts in 30 is a non-trivial amount of time. Point is, we def need faster insulin and faster, more accurate CGMs.
- shanselman 10y ago
  Because if you start exercising or eating NOW the insulin administered won't start working for 30 min and won't peak for 90-120 minutes. Because food hits you fast and by the time the system notices you'll have already drifted "out of the lanes." Diabetes Closed Loops are the same problem as controlling the Mars Rover. You move the joystick and nothing happens for x minutes. Then you wait another x minutes to observe the results.
  - deleted 10y ago
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- kellyisworking 10y ago
  A couple things - the insulin currently on the market works too slowly for a pump right now to fully close the loop – this functionality – notifying the pump of exercise and eating is part of the user control needed in a "hybrid closed loop" such as this. The user's insulin sensitivity given before, during or after exercise are very different than at other times. Different types of exercise affects body differently as well –HIIT for example raises blood glucose for a couple hours during and after – and then will significantly increase the sensitivity to insulin and many type 1's will drop rapidly. Aerobic activity will tend to drop blood glucose rapidly on it's own. Notifying the pump allows you to drop the levels given – something users do on their own now.
kellyisworking 10y ago
It's a great step – looking forward to the options coming in the next couple years with Bigfoot & ILet. Glad to see this on HN – made me finally comment. We should be complete building my husband's artificial pancreas next week based on open source code. For those interested in what's happening in the community – you might want to take a look at openAPS.
- shanselman 10y ago
  cosign.
shanselman 10y ago
Just to give a little more context. This is a start but it's by no means the finish line. Additionally, this is just one company's closed source system that is kind of the "Tesla AutoPilot" for diabetes. It will TRY to keep you in the lines but if there is a real turn or a stop light, you absolutely need to take control. Go google for "OpenAPS" and "WeAreNotWaiting" for existing open source systems that do more than this Medtronic system does...they are available now and there are over 100 people using them 24/7. Additional reading here: http://www.hanselman.com/blog/ThePromisingStateOfDiabetesTechnologyIn2016.aspx http://www.hanselman.com/blog/ThePromisingStateOfDiabetesTec... Source: 25 year Type 1 diabetic who is currently "looping" with an open source "artificial pancreas"
- aarondf 10y ago
  Hey Scott! Been following OpenAPS and WeAreNotWaiting for a while. Just got an old Medtronic pump with the right firmware version. What that community is doing is amazing, and you are a big part of it. Thanks for all you do! 27yo, 7yrs Type 1.
- shas3 10y ago
  Earnest skepticism: how can you trust Open APS without the rigorous testing required from companies like Medtronic? Sure, FDA regulations are not perfect. But they sure work in a large number of cases. While the DIY spirit of Open APS is commendable, hypoglycemia can be extremely dangerous and the risk is too high without FDA-level rigorous testing.
  - kellyisworking 10y ago
    Here's the inherent problem – insulin is a lot more dangerous on it's own than with any sort of hybrid loop system. The safety having a system like openaps - which includes a LOT of fail safes - is far greater than what a type 1 diabetic can do on their own. 1 in 20 people will die in their sleep because of hypos because he or she simply isn't fortunate enough to feel the blood sugar dipping and wake up to treat. The OpenAps safety measures are far far greater than what we have as a normal person regulating their day-to-day insulin dosing. I will sleep a lot easier knowing that I have something else watching, determining whether the boluses he's given might be corrected slightly so that he doesn't go low or high. Read about it at openaps.org – look at the reference design, and read about the fail safes where the pump will revert back to preprogrammed basal rates if batteries run out. Quite frankly anything with Type 1 diabetes is terrifying. At the end of the day, the risk with type 1 is too high for us to wait any longer.
yarou 10y ago
I've always been fascinated with metabolic diseases/syndromes like diabetes. It seems to be a symptom of the first world, i.e. affluenza, but there's this weird sort of trade-off where it can manifest itself (type-2 specifically) and become aggressive at a moment's notice. Clearly there is a strong genetic component, but possibly a strong environmental component as well. I think the markers we have right now (A1C and blood glucose levels) are insufficient in understanding the underlying mechanism of action for the disease. What's even more interesting to me is the relationship between endogenous growth hormone and insulin receptors. The relationship between IGF-1 and insulin in particular is very interesting - IGF-1 binds to insulin receptors. I hope that as we continue to advance in cybernetics and genomics (artificial organs are the first step to machine/human hybrids), we will gain a better understanding of the underlying mechanisms of the common ailments in our society.
- robobro 10y ago
  You don't know what you're talking about at all. Read what type 1 and type 2 diabetes are before you talk about them.
  - yarou 10y ago
    Clearly, I know the difference between type 1 and type 2. Type 1 is primarily genetic, which I may not have explicitly mentioned in my comment, and type 2 is a mix of genetic and environmental factors. Thanks for the two sentence reply fam, it really elevated the discussion.
known 10y ago
In people without diabetes, the beta cells make and release some insulin all of the time. This is a “basal” level of insulin that helps the body to function. When a person eats and their blood glucose level rises, the body releases an extra burst or ‘bolus” of insulin to help bring the blood glucose back into the target range. The insulin taken to manage diabetes is designed to work the way the body works as closely as possible. http://www.idf.org/worlddiabetesday/toolkit/pwd/insulin http://www.idf.org/worlddiabetesday/toolkit/pwd/insulin

64 points by helloworld 10y ago

In the 90s minimed brought insulin pumps to market. It was one of the first stock I ever bought and it blew up. They regularly wrote about their primary goal of creating an artificial pancreas. Eventually they were bought by Medtronic and I sold my shares. Glad to see they are finally achieving their long term goal... nearly 20 years later.

elmin 10y ago

Can someone explain why notifying the device of exercise and eating is necessary? Is it because 5 minutes is too low of an interval, or because the glucose sensor is slow, or because the body relies on other eating and exercise cues to regulate insulin.

cperciva 10y ago
The sensors aren't perfectly accurate; I don't know about the newer sensors which this closed-loop system uses, but the current generation only fulfills the accuracy requirements by reporting the median of 7 consecutive every-5-minutes measurements and carrying a warning of "don't trust these values if you have reason to think that your blood glucose might be changing rapidly". My guess is that providing notifications of exercise and food (aka. "I expect my blood glucose to go (down|up) right now") allows the model to be tuned to respond more aggressively to new data at some times and less aggressively at others. (The "less aggressively" side is probably most important: If the sensor suddenly reports a dramatic change in blood glucose in the middle of the night, the system should probably respond with "HEY WAKE UP THE SENSOR IS BROKEN" rather than "let's kill the patient".)
- shanselman 10y ago
  Exactly. Not to mention they are testing interstitial fluid and not whole blood, which introduces significant delays.
  - cperciva 10y ago
    I've found that the interstitial delay is pretty minimal; maybe 5-10 minutes behind fingerpricks (which themselves lag somewhat behind arterial blood, especially if your hands are cold). The dominating factor is the 15-20 minutes it takes before the median of a window reflects the new data.
    - shanselman 10y ago
      Sure, but we agree every minute counts. Also, CGMs in arms differ from belly, etc. 10 min when insulin starts in 30 is a non-trivial amount of time. Point is, we def need faster insulin and faster, more accurate CGMs.
shanselman 10y ago
Because if you start exercising or eating NOW the insulin administered won't start working for 30 min and won't peak for 90-120 minutes. Because food hits you fast and by the time the system notices you'll have already drifted "out of the lanes." Diabetes Closed Loops are the same problem as controlling the Mars Rover. You move the joystick and nothing happens for x minutes. Then you wait another x minutes to observe the results.
- deleted 10y ago
  [deleted]
- deleted 10y ago
  [deleted]
kellyisworking 10y ago
A couple things - the insulin currently on the market works too slowly for a pump right now to fully close the loop – this functionality – notifying the pump of exercise and eating is part of the user control needed in a "hybrid closed loop" such as this. The user's insulin sensitivity given before, during or after exercise are very different than at other times. Different types of exercise affects body differently as well –HIIT for example raises blood glucose for a couple hours during and after – and then will significantly increase the sensitivity to insulin and many type 1's will drop rapidly. Aerobic activity will tend to drop blood glucose rapidly on it's own. Notifying the pump allows you to drop the levels given – something users do on their own now.

kellyisworking 10y ago

It's a great step – looking forward to the options coming in the next couple years with Bigfoot & ILet. Glad to see this on HN – made me finally comment. We should be complete building my husband's artificial pancreas next week based on open source code. For those interested in what's happening in the community – you might want to take a look at openAPS.

shanselman 10y ago
cosign.

shanselman 10y ago

Just to give a little more context. This is a start but it's by no means the finish line. Additionally, this is just one company's closed source system that is kind of the "Tesla AutoPilot" for diabetes. It will TRY to keep you in the lines but if there is a real turn or a stop light, you absolutely need to take control. Go google for "OpenAPS" and "WeAreNotWaiting" for existing open source systems that do more than this Medtronic system does...they are available now and there are over 100 people using them 24/7. Additional reading here: http://www.hanselman.com/blog/ThePromisingStateOfDiabetesTechnologyIn2016.aspx http://www.hanselman.com/blog/ThePromisingStateOfDiabetesTec... Source: 25 year Type 1 diabetic who is currently "looping" with an open source "artificial pancreas"

aarondf 10y ago
Hey Scott! Been following OpenAPS and WeAreNotWaiting for a while. Just got an old Medtronic pump with the right firmware version. What that community is doing is amazing, and you are a big part of it. Thanks for all you do! 27yo, 7yrs Type 1.
shas3 10y ago
Earnest skepticism: how can you trust Open APS without the rigorous testing required from companies like Medtronic? Sure, FDA regulations are not perfect. But they sure work in a large number of cases. While the DIY spirit of Open APS is commendable, hypoglycemia can be extremely dangerous and the risk is too high without FDA-level rigorous testing.
- kellyisworking 10y ago
  Here's the inherent problem – insulin is a lot more dangerous on it's own than with any sort of hybrid loop system. The safety having a system like openaps - which includes a LOT of fail safes - is far greater than what a type 1 diabetic can do on their own. 1 in 20 people will die in their sleep because of hypos because he or she simply isn't fortunate enough to feel the blood sugar dipping and wake up to treat. The OpenAps safety measures are far far greater than what we have as a normal person regulating their day-to-day insulin dosing. I will sleep a lot easier knowing that I have something else watching, determining whether the boluses he's given might be corrected slightly so that he doesn't go low or high. Read about it at openaps.org – look at the reference design, and read about the fail safes where the pump will revert back to preprogrammed basal rates if batteries run out. Quite frankly anything with Type 1 diabetes is terrifying. At the end of the day, the risk with type 1 is too high for us to wait any longer.

yarou 10y ago

I've always been fascinated with metabolic diseases/syndromes like diabetes. It seems to be a symptom of the first world, i.e. affluenza, but there's this weird sort of trade-off where it can manifest itself (type-2 specifically) and become aggressive at a moment's notice. Clearly there is a strong genetic component, but possibly a strong environmental component as well. I think the markers we have right now (A1C and blood glucose levels) are insufficient in understanding the underlying mechanism of action for the disease. What's even more interesting to me is the relationship between endogenous growth hormone and insulin receptors. The relationship between IGF-1 and insulin in particular is very interesting - IGF-1 binds to insulin receptors. I hope that as we continue to advance in cybernetics and genomics (artificial organs are the first step to machine/human hybrids), we will gain a better understanding of the underlying mechanisms of the common ailments in our society.

robobro 10y ago
You don't know what you're talking about at all. Read what type 1 and type 2 diabetes are before you talk about them.
- yarou 10y ago
  Clearly, I know the difference between type 1 and type 2. Type 1 is primarily genetic, which I may not have explicitly mentioned in my comment, and type 2 is a mix of genetic and environmental factors. Thanks for the two sentence reply fam, it really elevated the discussion.

known 10y ago

In people without diabetes, the beta cells make and release some insulin all of the time. This is a “basal” level of insulin that helps the body to function. When a person eats and their blood glucose level rises, the body releases an extra burst or ‘bolus” of insulin to help bring the blood glucose back into the target range. The insulin taken to manage diabetes is designed to work the way the body works as closely as possible. http://www.idf.org/worlddiabetesday/toolkit/pwd/insulin http://www.idf.org/worlddiabetesday/toolkit/pwd/insulin