Even in this framing, it still feels like an extraordinarily valuable addition, and relatively low risk. It's also, of course, more to add to the patient's maintenance, but might help them or their caregivers sleep at night.
I agree with all that you've said, and this point in particular is extremely important. It's also the reason I moved from a DIY system like the one mentioned here, to a commercial system, once the latter was available. There is simply less hardware and software to juggle with the commercial system. There are fewer knobs, bells, and whistles, meaning I might not be able to tweak things to be in as tight control as might be possible with a DIY system (though with risks!), but overall it's been "good enough" for me, and greatly reduces the cognitive burden of having T1D. My experience clearly doesn't match everyone's, but considering I'm typically someone who loves to tinker, and has plenty of T1D experience (engineer, 34 years with T1D), I'm sure I'm far from the only one that feels this way. My glycemic control isn't significantly better than it was when I did it via constant monitoring and mental math, but the cognitive and emotional burden is much lower.
Failure detection is via alarms to trigger patient action based on the continuous glucose monitor (which has a different set of reliability issues) as well as patient symptoms.
Hypoglycemia becomes symptomatic long before blood sugar is low enough to result in death or serious debilitation and T1D patients know their symptoms well. The risks are not nearly as dramatic as you're suggesting as one isn't/shouldn't be relying on glucagon to prevent severe hypoglycemia, I don't think any system is designed or being conceived to operate in such conditions.
Hypoglycemia isn't really much of a problem anymore with current CGMs and pumps.
There is a what seems to be a significant number of people who don't "feel their lows."
> Hypoglycemia isn't really much of a problem anymore with current CGMs and pumps.
Current CGM's can still require hours of "warm up", and many current pumps still must be removed for things like swimming so they don't get penetrated with water.
Severe hypoglycemia to the point of what was described (death) is not reported in any of the recent device studies.
Level 2 or moderate hypoglycemia, very different from death, is reported at < 0.5% in recent closed loop system studies.
> Current CGM's can still require hours of "warm up", and many current pumps still must be removed for things like swimming so they don't get penetrated with water.
Current CGMs are water resistant but conveniently one is also not administering insulin while swimming either. The bionic pancreas is also dependent on CGMs and has the same limitations.
I'm really not sure what point you're getting at. Hypoglycemia is not what's being improved upon with current advancements, it's time in target.
Are there large-scale studies that show this for a dual hormone control algorithm (the context of this thread)?
Bihormonal pumps do not mean continuous infusions of both insulin and glucagon. The pumps pulse insulin when you're high and glucagon when you're low. They're not both administered at the same time or continuously infused in a "balanced state".
The context in this thread:
> However, if your brakes (glucagon) can sometimes fail completely
A bihormonal system would not result in more insulin being administered than an insulin-only system for a given blood sugar, if the glucagon pump fails we would have an insulin-only system where we have plenty of safety data. There is no mechanism by which a bihormonal system has higher risk of hypoglycemia than existing closed loop insulin system.
> In this case, you could be more aggressive in either direction of pushing BG, because you have a safety net.
Often times in an acute setting, yes. However patients who have had diabetes (T1 or T2) for a long time often lose a lot of their hypoglycemia sensitivity and symptoms. It's not nearly that simple.
You need to move forward, and therefore must occasionally have a foot on the gas (insulin). The gas pedal failing, causing you to stop moving forward, is not urgently dangerous (hyperglycemia). However, if your brakes (glucagon) can sometimes fail completely, that could cause you to die almost immediately if you're moving too fast toward danger (extreme hypoglycemia). Given this situation where brakes are unreliable, do you want your automated control system to rely on them and push you to dangerous speeds?