Amin Zayani talks with Diabetes in Control Publisher Steve Freed during the ADA 77th Scientific Session in San Diego about the potential for other ways his product, MedAngel, could be useful to the person who is managing their diabetes with insulin.
Amin Zayani is the founder and CEO of MedAngel. He works with his team of engineers, pharmacists and designers on improving drugs safety for patients who live with diabetes and rely on temperature sensitive drugs like insulin.
Transcript of this video segment:
Steve Freed: People with diabetes, I don’t have to tell you, have a lot of things that they have to think about on a daily basis. Some people say, “Do you live for your diabetes or do you just live?” So, what happens? Does it actually sound an alarm? Because I’m not going to look at that every 20 minutes to see if my insulin is ok. Most likely it is, but there’s a chance that it could go bad. So it actually sounds an alarm that you can hear and then you can check and see how long it’s been at that temperature? Does it give you an alarm before it reaches the critical temperature? So as the temperature is going, you have set so that it gives you an alarm, like you need to pay attention to this. In asking a number of physicians about this product, one physician came back and said, well it’s never really happened, maybe once in a hundred years. Where he found it was useful was his trailer. Most people will carry some insulin with them and then if they’re going someplace for a week or so, they’re going to have a suitcase and they put an extra bottle in their suitcase. The one in a suitcase is going to be in a storage facility on the airplane. And it’s going to be outside whatever. It’s happened where the cabin wasn’t pressurized, you don’t know and obviously the product froze and then you land and the product was thawed out and you would never know. This, while you are sitting on the airplane, would give you at least some sign. You may not be able to do anything about it until you land, but it would give you warning that you may need to get another bottle of insulin, because it could save your life. Most people that I’ve asked about this, it’s happened to, I don’t know how many people, everybody at one time where the insulin is not doing what it’s supposed to do. The first thing that comes across your mind is that it’s not you, it’s the insulin. Something’s wrong with my insulin, maybe. So the next thing you are going to do is give yourself another shot of insulin to find out, which could be very dangerous. Have you found other places where it would be very useful?
Amin Zayani: Yes, it’s interesting you say this because we always say that we are not in the cold chain business or the temperature sensing, we are in the peace of mind business. The problem is that you don’t know and the absurd part is that the cold chain is very, very meticulously maintained until the point of dispensing it to the patient. There is a number of processes and methodologies that are used to determine if any medication is still safe or not. For example, one of the processes, I would take it as an example because it is the easiest to explain and understand, is failure mode effect analysis. How that works is you take a score that is made of the effector for the severity of the failure effect. For example, what is the worst thing that can happen if this medication does not work? In the case of adrenaline, it’s extremely high. In the case of insulin, the severity can be either blood glucose levels not under control, even maybe falling into DKA, or just long-term complications because of diet blood glucose level not being under control. The second factor is the probability of this incident happening, so, how good is a refrigerator, for example. In fact, there is a number of factors that are very, very specific. So let’s say if it is in transit and it’s in a truck and the truck is crossing a border and there’s a customs inspection, then that has a factor. If the truck has a flat tire, that has a factor. In our case, it’s how well is the refrigerator maintained, operated, and how long the storage period is. The third factor is the probability of detecting this. So, all this is done very, very well before dispensing to the patient. If at any step, you cannot monitor the temperature and logic of the medication, then it’s just not good to be given to patients. So, this is just one example. The older generation of doctors who are not used to the new technological improvements have a bias, because they grow up and they operate in the 60s and 70s when this kind of equipment was only accessible to big pharma or to large logistics operators. Now, everyone has one of these and electronics cost is extremely low and everything is connected. So, there is no reason not to extend these standards beyond dispensing it to the patient until the moment of taking the shot. So, what’s really, really absurd is that if the duration of storage of insulin or any other medication at the patients home is much, much longer than any other step, because you get a quarter or a few months’ worth of insulin stock to keep it at your home, but then you don’t have any of the safety processes or procedures before that. If we apply the standards that are in the previous links of the cold chain to after it’s dispensed to the patient, that would be not just a no-go, but it would be a massive disaster. Some professionals understand this and they see the point in it. Others have a historical bias or a personal bias, but you cannot argue with logic. I can give you a small example. I had recently an episode where my blood glucose was completely out of control and I tried everything and it was just impossible so I went to see my doctor and the first thing she asks me is, the first thing she says is “We’re going to give you a fresh batch of insulin, we’re going to try for another three days just to rule out this probability or this risk factor”, because what you’re doing is you’re troubleshooting one factor after the other. But I was able to show her that my insulin was stored properly the last three or four months. It’s not that factor, we could immediately move to the next factor and test it and we saved probably a few hundred dollars’ worth of insulin and three days of frustrating testing on my end. I’m really happy to see positive feedback from professionals, clinicians, endocrinologists, especially at ADA this year. I’m really, really happy about the positive feedback.
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