To answer Rick's question, all current integrated pumps and glucose meters will suggest a dose to be delivered manually. For example, the Omnipod wireless pump with its integrated meter will calculate a dose based on past insulin delivery and current glucose tests. The patient/user can then accept or change the dose and deliver it manually.
In addition, most if not all standalone insulin pumps that are not related to glucose meters will also suggest a dose if the user enters a current glucose level and/or amount of carbs to be eaten.
So, what's missing from the current systems?
The answer is the safety of real-time glucose testing (continuous monitors) connected to automated insulin delivery and possibly automated glucagon delivery. Real-time systems can prevent dangerous hypoglycemia (low blood sugar) as well as promote more stable glucose values, improving quality of life. Ask any Type I diabetic or parent of a Type I child, and hypoglycemia is their number one concern.
Most current meters do not test blood continuously, so a test performed now will not predict a rising or dropping blood sugar. As a result, Type I diabetic with a normal glucose test of 105 may be rapidly dropping into hypoglycemia, which can result in unconsciousness and death. A real-time glucose monitor (CGM), such as Dexcom, can predict this decline in glucose and allow the patient to take glucose to return to normal.
But what about the automated system? Why is it needed?
A closed loop system including an insulin pump and continuous monitor could finetune a dose on a real-time basis, eliminating hypoglycemia entirely while preventing hyperglycemia. That is the goal of current trials, and a hope for millions of Type I diabetics like me.
Rick, I am also an insulin pump user with a wireless meter (though not CGM) and am optimistic that in the next few years we (or at least Europe) will have a closed-loop artificial pancreas that is sufficiently accurate and reliable. The Dexcom CGM (continuous glucose monitor) is already quite reliable. However, I am not as confident about the security of a smartphone or cloud-based system that could be hacked to deliver a dose. It must be absolutely secure before I'd use it.
You're right and the pump helps me keep a tighter control on the glucose level, but I never would use it with a smart phone. As it turns out, uploading the info on glucose levels and pump activity up to the cloud is possible, so the Dr can review. But that log is rather limited & I have looked for an Android or Apple app that would let me log more complete info and send it up to the cloud, but no luck yet.
I am a Type 1 and took 4-5 shots per day for 20 years, til I got on a pump 10 years ago. Now my glucose meter is linked via Bluetooth to the pump and it has been very reliable, using it 24/7. I often thought about the security though and having someone be able to adjust my pump/insulin without my knowledge. The algorithm for proper insulin injection has to be akin to navigating the Voyager 1 at the edge of the solar system.
That's a very good question Rick. I find it interesting that the phones won't need FDA certificiation. I understand there are a lot of gripes about the FDA certification process, but this may be a good illustration of why that process is in place. It's one thing to be annoyed about dropped calls or your phone freezing up, but if your health depends on it working properly, seems like there could be quite a reliability gap between different models.
Yes, why not? I think such a artificial pancreas is not more dangerous than a cardiac pacemaker. And medical devices have to guarantee various safety standards like IEC 61508. But I can not imagine to wear such a device at bedtime or during sporting activities like jogging.
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