Amin Zayani Transcript

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Steve Freed: This is Steve Freed. We’re here at the American Diabetes Association 77th Scientific Studies. We’re here to present you with some exciting interviews with some of the top endos from all over the world. We have a very unique guest: Amin Zayani, who is involved with technology and diabetes with a product that I find, there was always a need, but nobody ever developed the product to take care of that need. I don’t know why. It should have been developed when insulin was discovered back in the early century. So, maybe you can start off by telling us a little about yourself. You came all the way from Germany to be here. So tell us a little bit about yourself and what you do.

Amin Zayani: So, my name is Amin. I was born and raised in Tunisia, North Africa. I moved to Germany to study environmental resource and management. So I’m a solar energy engineer by training, but I also live with Type 1 diabetes for 10 almost 11 years now. I take daily injections to stay alive and well. A couple of years ago I had a very frustrating incident when my insulin stopped to work. I was taking loads of insulin and my blood glucose wouldn’t drop. I ended up in the hospital, but luckily without DKA. I realized later that my refrigerator failed to keep the right temperature to store my insulin. It was a very frustrating incident. I tried to find a solution to prevent it from happening again. I didn’t find it, so I decided to make one.

Steve Freed: So, that’s interesting. One of the other things I find, including the fellow that just walked out of here, developed a very unique product for the blood glucose monitor. Basically, if you have questions you can ask the CDE and text and get a response. Technology is really changing rapidly. What I find is that people that develop the most efficient and breakthrough products when it comes to diabetes are people with Type 1 diabetes. That’s because you’re passionate about what you do. You see a need, because of your diabetes and you want to do something. Not just for yourself, but you want to do something for the masses out there. So that makes you a very passionate person when it comes to helping others. That’s great, because those are the type of people that I get to work with all the time. Everybody I work with involved in diabetes is passionate. We don’t involve ourselves in diabetes to be millionaires. We do it because we want to help people. I can certainly say the same for you, otherwise you wouldn’t have developed it. So let’s talk about the product a little bit. You have a unique product, it fills a need so tell us a little bit about it.

Amin Zayani: As I told you earlier, it all started on that day when my refrigerator accidentally froze my insulin and made it completely useless. There was no way to find out because it doesn’t change color or consistency and I was just injecting loads of it and it didn’t work. It was quite frustrating because this is the kind of stupid accidents that shouldn’t happen. All you need something to keep track of the storage temperature and to alert you when there’s a problem. I tried to find a solution that does this because the whole thing is very closely and meticulously monitored and processed until the moment of dispensing the insulin to patients. I thought that it’s not a technology problem and that it must be another kind of problem, why this doesn’t exist. To make a long story short, I decided to come up with a solution to this and I can show it to you. It’s very easy to use and practical device. It’s a wireless temperature sensor that continuously measures the temperature of insulin or any other temperature sensitive medication. It is placed with the insulin. In my case, this is my insulin, in this case. And also in the refrigerator at home. It’s connected wirelessly with my phone. Every time it starts to get dangerously hot or cold, I get an alarm. This is basically the general idea. A number of details or features make it very special and unique. One of them is how easy it is to see the interface and understand what’s happening. For example, it’s showing a temperature of 84 degrees Fahrenheit, which is a very abstract figure for someone who’s not trained as a pharmacist or who doesn’t have the understanding but a green heart is very easy to understand. This is something my little cousin understands or my grandmother understands. You look at the screen and you see that it’s a green heart and you know you’re fine. When it gets warm, then it turns into an orange and raising heart and a red heart upside down is too hot and then the same in the other direction. If it starts to get cool and when it’s too cold. This is one main feature of our product. The second feature is that all you need to do as a user is to select your medication from the list of supported medications we have. We support all of the insulins that are available on the market in the US and in Europe. All you need to do is to select the medication you are using, the insulin you are using. The package, so if it’s a vial or a cartridge or a throw away pen and that’s it you’re set, you’re done. The app will know what is the safe range for your insulin or your medication, whether it’s open. So after it’s taken out of the fridge or when it is still in the fridge and will alert you only when it’s critical. So, you can either protect it if it’s not too late, or you know with 100% certainty that it’s no longer good and you need to get fresh insulin.

Steve Freed: You mentioned about heat. What about cold?

Amin Zayani: Cold is really the one overlooked problem because we also call refrigerators the “frenemy”, because you think you protect your insulin from the heat by putting it in the refrigerator and that may be even worse than getting it out of the refrigerator. The science behind it is very straightforward. Insulin is a protein and it degrades when it’s exposed to heat. The fast version of a protein degrading is when fry an egg in a pan. The proteins lose their structure and they have a different structure. This is what happens slowly when insulin is exposed to heat. So, starting the moment you take insulin outside the refrigerator, it starts to slowly degrade. The higher the temperature is the faster this process becomes. This is a very well-known problem. All educators, all clinicians educate patients properly about this. Most patients are very aware of this problem. This is why there exists a multitude of cool bags and other solutions to keep insulin cool. The overlooked problem is the freezing problem. The refrigerator at home is not made to store medications. Refrigerators in the pharmacy are regularly maintained. They have super accurate and redundant thermostats and regulation mechanisms. They are operated by professionals who take protocols and they’re really very closely monitored, maintained, and operated. The refrigerator at home is made to keep cheese, or butter, or eggs, or milk from going bad but the way the regulation is very rough. So it can fluctuate, it does in fact fluctuate greatly. Sometimes it goes below freezing temperature for quite a long time. In fact, in a recent study made by a few Dutch hospitals and universities, it’s been proven that 25% of patients accidentally freeze their medications in the domestic refrigerator. In fact, 93% of patients do not store their medications in the domestic refrigerator as it is recommended by the manufacturer. So what happens when insulin is exposed to freezing temperatures is that the solution becomes crystals and these crystals break the protein of insulin completely. So if insulin is frozen, it completely and totally loses its effectiveness. This is why we call the refrigerator the “frenemy”.

Steve Freed: So, let’s say it does freeze. What exactly happens on your cell phone?

Amin Zayani: There are two cases. So either you are around this refrigerator and the temperature is dropping very fast so you get an instant alarm, because the sensor is connected to the phone and it will give you an alarm that it’s getting too cold too fast. What you do is either you fix the setting on the refrigerator. You take it out of the refrigerator.  But if you’re not around and this happens in your absence, then the next time you are around the sensor and let’s say you go home and near your fridge, the sensor connects with the phone, it will sync all of the data it was monitoring in your absence. In fact it has enough memory to store up to 7 days of data. You will know how long was the exposure and how cold was the temperature. With this information you can make an informed decision about whether to discard it or not.

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.

Steve Freed: For someone that says, I’ve been taking insulin for 40 years and never an issue, how do you answer that?

Amin Zayani: It’s very simple, it’s like anyone who tells you my grandma died at 110 and she smoked every day. It doesn’t mean that smoking doesn’t kill, it just means that she got lucky. Until, the 60s and 70s, pregnant women used to smoke and drink and that was not a problem, but I want to say is that if we look back and we see how things were before an innovation or an invention comes, and many people are satisfied. For example, before the invention of seat belt, nobody put a seat belt on. But once seat belts were available in every car and it became a legal obligation to put them on, everybody started putting them on. I think that there will always be people who will deny stuff, like smoking doesn’t kill or whatever, but the science and the logic is very straightforward and I believe that I’m really happy that the awareness about this problem is raising. The advocates are really vocal about it. The new generation of doctors and professionals are aware of it and I predict that in the next one to three years there will be a temperature monitor in every refrigerator and with every insulin pen and vial. Maybe not made by Med Angel because there are newcomers on the scene as well. But I think it will be standard, very soon.

Steve Freed: Are there any numbers that we can look at. If I’m a Type 1 diabetic and I’ve had diabetes for 40 years. What are the chances, the storage of the insulin will degrade enough where it will probably use it without knowing. What are the chances that that will happen?

Amin Zayani: It’s 100% over 40 years because the study I referred to, I can send a link or reference to it showed that. It’s a study in the Netherlands and they took 275 patients who store medication in their domestic refrigerator and 93% of them failed to store them according to manufacturer’s recommendations and this was only in 3 months. So you extrapolate for 40 years.

Steve Freed: So, a bottle of insulin now costs, let’s say on average $400 a vial in the US. If you use a vial a month, that’s 12 times 400. That’s about $5,000. If you use it for 20 years, that’s a lot of money. Is that one of the things that you market that this can save countless dollars and do I have to use your product, does it cost $100,000 for your product, does it cost 30 cents for your product? What’s it going to set me back as far as my dollars and cents?

Amin Zayani: It’s funny you mention this because it’s completely different from one market to another. In Europe most people get their insulin paid by the social system. In case of a doubt, they toss it, they get a new prescription, it costs them nothing. So that financial incentive is not as present as in the US. That’s probably why we do almost 80% of our sales in the US. It’s because of this. Because people think, ok, this takes the uncertainty away, and that saves me a vial or a pen a year, it pays off for itself. That’s because our product is extremely affordable. It costs $49 for two sensors. People see the value in it immediately, especially if they had this experience or this situation before. If they were standing in front of their refrigerator or cool bag, or at any situation and they doubted, is this still good or not? They had to get rid of that doubt by throwing that vial or pen, which is really sad.

Steve Freed: I like your idea, more so because it actually saves the doctor’s time, because it takes away the question, is it the insulin. Go out and buy another bottle and let’s see. That’s always going to be the answer. This can actually prevent that from happening and take more immediate steps to take care of the problem, just like what happened with you. You can become insulin insensitive for a number of different reasons, whether or colds or flus or things like that. So, I applaud you for coming out with this. You saw a need and I can’t believe that insulin’s been on the market for over 100 years and yet you’re the first one after 100 years to come up with this problem solver. So, with that, I want to thank you for your time.  I appreciate you being here and I wish you the greatest success and I’m sure we’ll be talking again.

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