What's New With Diabetes Technology in 2019?

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[Music] this is going to be a sort of a hands-on show-and-tell evening so I'm gonna spend some time talking about certain technologies that are out there and that are new and then we've brought samples of all of them so we're gonna kind of trade off back and forth with Marlene showing them after I talk about them so really excited to be here and speak with you about this subject that I'm really passionate about and Marlene and I are often bouncing back and forth in the clinic teaching people about all of the latest things so these are some of the companies that I've worked with over the years and my disclosures and here are Marlene's and so before we dive in to showing things just wanted to I guess get some shouting out from the audience what technologies in in the diabetes space have you heard about what are you most interested in so have at it Libre continuous glucose monitoring more libre insulin pumps alright and Dexcom good all right we're gonna cover all of those so the the agenda for the evening is to start talking about connected insulin pens which actually nobody mentioned so that's great so we're gonna teach you a little bit about this is still a new area we will talk about continuous glucose monitoring and the various options I'm going to spend just a minute on some new digital coaching services that can that can help with diabetes and we'll talk about insulin pumps and in particular closed-loop insulin delivery which you may have heard about being called the artificial pancreas but we're going to talk about where that really is and and why we might not call it that so how many people have seen something like this all right a few so this is this is a diabetes log book so for years and years and years we asked people with diabetes to write everything down so that we can help them understand what's going on with their bodies and manage the conditions so this means the doses of insulin that they're giving themselves their blood sugars people would write everything down and so fortunately just like everything else in your lives we're transitioning to more modern technology and using the tools available to us and and hopefully making lives easier for people and so there is increasingly more modern software that shows you your continuous glucose monitoring tracing here and the insulin doses that you're delivering here and as the patient you may not actually have to extend any special effort to get this information in one place to work through with your physician or your nurse or a diabetes educator to go through and talk about it so let's now look at where are all these data source is coming from and what's available so starting with connected insulin pens so these were actually first approved in 2016 but are really just starting to hit the market now so for most people you probably haven't really seen or heard about these yet so for many years you had to draw up insulin from a vial with a syringe and then inject it maybe 1020 years ago first came out with the insulin pen but again the information was lost so you might inject the insulin and not remember how much you gave if you didn't write it down in a book somewhere so what these do is actually capture just using bluetooth and sending it to your cell phone capture the dose information from the insulin pen so you can remember exactly when you took your insulin how much you took and you could share that information with the doctor it also has a calculator in it so that your doctor can kind of put in what settings they recommend you use how much insulin you should take with each meal and you actually just calculate your dose before you're going to eat so it can give a lot more flexibility so we're gonna show that here it's an actual in pan that we managed to get our hands on it opens like that there's a cartridge of insulin then that would fit inside the needle would fit on the end of that and then you would dial up your dose and give it and it would require the insulin dose and the time on one of your apps on your phone it'll also calculate the insulin dose for you if you have insulin to carb ratios and you have the formulas in order to do that so that would be programmed into your pan you would dial it up take it it would record the amount that you took and it would track how long it was out there or the duration of the action of it so it can be a really handy tool now the company that makes this is still a small company in San Diego and you know it's a little bit slower for them to get out into the market into all of the pharmacies a much larger company novo nordisk is coming out with their version of this connected pen sometime later this year so those will probably be in much more widespread availability and so some of the advantages if you've either yourself or with a loved one seen anybody struggle with some of these problems as they're giving themselves insulin it can be very easy to forget to take an insulin dose to give yourself two doses back-to-back I left the house yesterday and forgot to turn the alarm off in the morning and woke up my wife and daughter and they were not very happy with me and you know just little everyday things like that can be very hard to remember and so having something that actually reminds you and can help you with that can be super useful so again can help with dose calculations and drive the conversation with your doctor because you actually will have rather than the doctors saying you know how have things gone the last few months and you have sort of a general conversation you can actually look at the information that the real information that's happened over the last few months and discuss it together so it can drive much higher value visits with your with your clinical team okay so let's talk about continuous glucose monitoring so Marlene and I were talking about this the other day in clinics it would have been sort of the life changing new technologies over the years so the first one was really the invention of finger stick blood sugars in the 1970s and 1980s so before that there was some urine testing so these are typical finger stick glucose meters still it's a very painful and arduous process can be expensive continuous glucose monitoring was first introduced in 1999 the the early technologies were very slow inaccurate expensive and so they're really starting to come into their own in more recent years and we'll talk about some of those in a minute and then closed-loop insulin delivery or the artificial pancreas was first introduced in 2017 so this was one of the first fingerstick glucose meters called affectionately the guillotine you can see why it might be might have been called that and you know so I'm gonna jump all the way from the guillotine skip the last 20 years to what the most recent experience is which is the Dexcom g6 continuous glucose monitor so Marlene has that here you want to talk about the so this is the insertion device that puts the sensor under the skin people do this themselves the sensor then sits underneath the skin little transmitter sits on top of it that information is then beamed over to your receiver and it will show you what your glucose level is now what direction the glucose is moving in is it going up going down staying flat and where it's been in the last several hours so you can also set alarms on here so that it will let you know if you're dropping too low if you're going too high you can share the information with a loved one that can follow your glucose readings as well as you it's great for adults it's great for parents who have children with diabetes who are at school you can watch this from from home and know that everything's okay or that something wasn't okay but it got fixed this this oh sure I really see it it's about three eyelashes thick and a maybe a quarter of an inch to a half an inch long that's what sits underneath the skin this is then taped on the skin and it sits flat on the skin people wear it on their abdomen you could put it on the back of your arm and so it's got a pretty flat profile that's what's actually on top of the skin that gets changed every 10 days yes so what goes under the skin is just a tiny little wire sensor that you know most people and I've worn them as well say they don't really feel them when they're wearing it so yeah that the big chunky part sits on top so you can see what a what a major change that is right so from going from pricking your finger all of the time which is is painful only gets you one data point at a time so you're getting one number but in real life as with everything in our bodies if you remember back to your science classes about homeostasis the body is constantly epping and flowing and trying to keep itself in balance and your blood sugar is no different so getting a single moment in time blood sugar is very different than you know Marlene was talking about where you're actually seeing the ebbs and flows of your blood sugar over time and it's much more information that it's providing you and actually the newest ones are approved as accurate enough to not have to do fingerstick calibrations so you can just insert it on wear it for about two weeks and not have to do finger sticks unless you suspect that that something is wrong and that you're not getting an accurate reading and I'll get into a little bit more detail about the timing so how does this compare to the different ways you might measure your blood sugars so many of you have probably heard about the hemoglobin a1c which is the test that all of the TV commercials talk about and that your doctor may be asking you to get every three months there's the finger stick blood sugars that we've talked about and continuous glucose monitoring so how do we think of about these differently how do they complement each other so the a1c remains the gold standard test its measuring three-month averages of your blood sugars and all of the studies that have been done the clinical trials over the last several decades have used that to predict the risk of diabetes complications so it remains the test that helps predict your risk of diabetes complications but it doesn't really give much guidance into how you're changing your medications because you're just getting a three month average and I'm going to show you in a moment how averages can be misleading we've talked about finger stick blood sugars and continuous glucose monitors so one of the other advantages of the of the continuous glucose monitors is that they can give you alarms or alert so if you're using insulin you go to sleep at night concerned about whether you might get a low blood sugar overnight the the continuous glucose monitor can actually alarm and wake you up and prevent prevent you from having a low blood sugar that you don't notice so here's where I was saying that averages can be misleading so these are two patients who both have an a1c of 8% and you can see the person on the bottom has some squiggly lines or blood sugars going up and down that's pretty normal to see blood sugars go up and down all day and the person on top has much wider swings so they have many more highs and many more lows and so if you go in and you get just two hemoglobin a1c you would never know that you might be having all of these highs and lows if you're only looking at the average so this is one of the reasons that we think continuous glucose monitoring can be so impactful and so valuable is to actually see the variations in your blood sugars over the course of the day and not just have an average okay so the liebre so anybody know who this is alright so Theresa May wears a Libre so one person who's slightly less impressive and important than Theresa may wore one but I just wanted to put myself on the same slide as her probably the the first the first last and only time so the Libre Marlene will show you in a moment actually let's do that now one issue so this is actually inside of a plastic case so it looks a little bit bigger than it actually is but really the only piece that would be on the outside of the skin is this piece right there it's about the size of a quarter and maybe two quarters thick it goes underneath the skin most people wear them on their arm it's got an insertion device that pops in I've helped many many patients put these in everyone says it does not hurt then you have your reader and so when you turn your reader on you can actually scan the Libre so if I have my Libre on my arm I scan it and it shows me what my glucose level is now it shows me the direction that it's going in is it going up is it going down is it fairly flat and it shows me where it's been the only problem with the Libre is right now it doesn't have alarms so you actually have to scan it in order to see what's going on it's not going to alert you so these are worn for 14 days you take it off put a new one on takes an hour to warm up before you get readings and so to answer the question earlier about battery life and things like that so the Libre actually doesn't have it's disposable so there's no no battery that you have to worry about with the Dexcom g6 there is a transmitter that gets replaced every six months transmitter oh sorry three months thank you yeah a new one so let me show some cases of people who have been in our clinic to show you what what these things can do and how they can help so this is a tracing from somebody wearing Libre this was a 54 year old who'd had a kidney transplant takes some insulin takes a medication called rip a gland I'd to help or the blood sugars and what I think is is pretty clear here is that this person has very high blood sugars every afternoon and evening and every morning is dipping low into the redzone and so again thinking about if we were just to get an a1c we might see the average and not actually know that that was happening you could also imagine somebody doing finger sticks at different points in time so you could get a finger stick here maybe a finger stick here and you might know that there was something wrong but you wouldn't really get the same amount of information and especially to see the patterns to see that it's the exact same thing happening every day we can make some adjustments to the therapy plan with a lot more certainty and a lot more information so here's another patient 70 year old gentleman who has type 2 diabetes take some medication called metformin had a hemoglobin a1c of 7.3 taking a smaller dose of metformin increase that was able to get the a1c to 6.5 cut down on his dessert and he said I'm never gonna do finger sticks so I convinced him to do a Libre and here's what we found so we saw that he was mostly having good time and range 94% time and range average blood sugar was 121 and so some people might say let's stop there that's you know that's good enough but if you actually look at the detailed data something jumps out at you and if you look one step closer you can see another trend so every morning something happens called breakfast now you got to eat breakfast but it turns out he said my breakfast every morning is a tall glass of orange juice and a banana [Laughter] yes so lots of carbohydrates in those and his body was not able to really handle it well and was causing these blood sugar spikes every morning and if you look actually before and after the spike so if he had been doing finger sticks as we usually tell people to do do a finger stick before you eat do want a couple hours after you eat what we would have seen our blood sugars that don't look so scary blood sugars right around a hundred before eating around a hundred after eating people might say that's fine don't change your therapy but when you see that spike you think you know what let's cut out the orange juice let's cut out the banana and he did and and saw dramatic improvements so how how are people getting Libre is in terms of access and cost so for people on Medicare they are requiring you to be on four finger sticks per day or on insulin so it is a little bit more restrictive in terms of who's able to get Medicare to pay for one private insurance companies seem to mostly not be having requirements the cash price is about $60 per sensor I just looked yesterday on on good rx that you know what the coupon prices were and they were around $60 each but if your insurance company's covering it there are coupons from the company that are capping it at about $75 per month so they are not cheap but many people are paying this much money or sometimes more for strips anyway and so it's a it's a reasonable trade-off the other thing we've been coaching people is that you know if you if you have type-2 diabetes you're not on insulin you're not at risk for low blood sugars you can get a lot of information by wearing this once like this last gentleman I showed you with the banana on the orange juice so you could get one and do it one time you could do it once every few months and get a lot of information about what's going on with your body and not need to wear one all the time okay so I'm gonna spend a moment about some of the coaching apps and tools so there are a growing number of companies who are using digital technology combined with a coach in the cloud so these are often people who they pay who may be located all over the country who are diabetes educators or nurses or other clinical people who are text messaging with the with the customers or the clients and providing them some coaching so every single one of these companies has a little bit different flavor so some of them focus more on pre-diabetes some of them focus more on on diabetes but essentially they're all going to give you either a scale or a glucose meter that's connected to the internet and connected to their coaches and actually have someone for a monthly fee who's providing you coaching some insurance companies are paying for these services some are not so it's it's very much individualized at this point as to whether whether those are covered one of them is is quite different than the others which is vertical which is doing an extremely low carbohydrate or ketogenic diet they're also very expensive some of their early data is showing that they're they're having a lot of benefit in improving outcomes for people with type 2 diabetes but you have to be motivated to go on on a diet like that on Duo what's notable about them I'll show it in a second is that actually as I spin off from Google and they are using some interesting technology that you might use in other walks of life from Google so what on Duo is bringing to the table so same as other companies they're giving you the kit but they're allowing you to take photos of your food and everybody as I think I heard one of the people from the company say at a conference all of the photos you're taking of your dogs and cats and of your food at home are being put to good use so they're trying to build artificial intelligence to recognize food images I don't think they've cracked it yet but that's their goal is to actually help on stand what's in your food to help drive better care decisions for the for the coaches and for your lifestyle okay so what about continues glucose monitoring if you have type 1 diabetes because it's a little bit of a different animal than if you're dealing with type 2 and to give a little bit of a historical perspective so the first insulin pump came out in 1983 and that was from what used to be mini med now Medtronic and as I mentioned earlier the first continuous glucose monitor came out in 1999 these were pretty rudimentary devices at the time but things have gotten better and if you look at the data of people across the United States with type 1 diabetes continuous glucose monitoring has grown pretty rapidly just in the last decade so only eight years ago in 2011 just six percent of people from this large survey cohort called the t1d exchange were using continuous glucose monitoring and that's up to 38 percent so quite a dramatic improvement now I actually look at this and think there are 62 percent of people with type 1 diabetes not using continuous glucose monitoring and so let's let's talk a minute about why I think that should change I think a lot of people were turned off by the technology in early years there were a lot of issues with how big they were the insertion could be incredibly painful they were very expensive and not all insurance companies covered them for people with type 1 diabetes as as clinicians we were often writing letters begging insurance companies to cover these things the accuracy wasn't very good you still had to do for finger sticks a day to try to keep it as accurate as possible you had to replace it every three days or sooner and it was really hard to get the information off of the device to share it with your doctors and kind of do everything with it so you can imagine given that why a lot of people might not have been using them but with the devices that Marlene was showing you with the Dexcom with the Libre they're starting to get much smaller not snagging on clothing quite as much as they used to you can wear them in swimming pools in the shower the insertion is much easier and is painless insurance companies for people with type 1 are generally quite good at covering these as long as you meet pretty minimum requirements that that most people do meet of course co-pays and coinsurance are still very variable depending on what plan you have so in the modern era just because something's covered doesn't mean it's cheap unfortunately the accuracy has gotten much better these two devices we've talked about no longer need fingerstick calibrations can actually wear them for 14 days and you can now put the information on your cell phone into web applications and places where you can actually make use of it so the world has changed and so the endocrine Society which is is our largest professional organization for endocrinologists comes out with their guidelines and more or less their guidelines say that every person who's got type 1 diabetes and is willing to do so should should have and use a continuous glucose monitor and and I believe that strongly so here the comparison of the available devices we've talked a lot about the libre we've talked about the Dexcom g6 the g5 is is essentially being phased out Medtronic send light to similarly is mostly mostly falling away so the way we think about this in our office is that for most people with type 1 diabetes the Dexcom g6 is the most accurate device it's the one we prescribe most it's the easiest to use I'm sorry I said 14 days it's 10 days again I'm thinking about other models here free style Libre is 14 days and then the other one we see quite a lot of is the Medtronic Guardian 3 the reason for using that is we're going to talk in a few minutes about closed-loop insulin delivery systems and if you want to use Medtronic's closed-loop insulin delivery system you have to use their sensor as part of it we typically in our practice don't prescribe a lot of those as standalone sensors because we've found that people seem to like the Dexcom sensor better a new entrant to the market is a company called sensi onyx that makes a sensor called ever since and I'm going to show you a little bit about that in a minute that's the first sensor that's actually a much more long-term you can wear it for 90 days but it's actually a small surgical procedure to go under your skin it's not an self insertion like the ones we've showed you here so our feeling is if you have type 2 diabetes you're not on insulin you want to learn more than the free style Libre is really the right thing it's cheaper it's quite easy to use a lot of insurance companies cover it it's less accurate than the Dexcom but it's accurate enough to give useful information for most people with type 1 diabetes if you're not using the 670 G we tend to prescribe the Dexcom g6 so I want to give you a little bit of a peek under the covers at what your doctor and and other clinicians are looking at and thinking about as you come in with your continuous glucose monitoring data so we look at do we have enough data to even think about this so if you only have one day of data then patterns may not mean anything if you have two days patterns may not mean anything and similarly if you haven't worn it at least 70% of the time there's going to be dropouts in the data what we're really looking for when we think about time and range is about 70 percent more than 70 percent time and again we're talking really here for people with type 1 diabetes is what I'm focusing on here percent time in hypoglycemia should be less than 3% and percent time in hyperglycemia should be less than 25% these are very rough targets we individualize these with most of our patients but just to give you a sense of how you might think about this as you look at your own information so if you get a report from Libre and you're looking at it it's going to show you this time and range we like to see that as high as possible we also do look at the standard deviation because that gives you a sense of how much undulation there is going from high to low and high to low one cool thing I've never actually don't have anybody who uses this but I think this is showing the possibilities now that these technologies are actually connected to Internet in a way they weren't in the past this company had a clever idea that they actually adjust you on your if you have an iPhone you can connect the Dexcom information into their app and you can preset an emergency contact so if you get a low blood sugar it'll automatically send a text message or call that person so all kinds of possibilities as these things start to become connected to the internet with what application developers can create when you come see us in our practice we'll probably sit down with you and and talk through something like this which you saw earlier where we're gonna pull in information from your if you have these connected devices we're gonna pull in information from your pump or your continuous glucose monitor or your insulin pens and we're gonna walk through the data and try to use it to help guide your care in a more targeted way than then we might be able to do with just an a1c okay so here's the ever since implantable continuous glucose monitor so full disclosure we've never actually used this in our practice and we don't have one but these are these are out there in the world there are increasingly some endocrinologists who are putting them in we've just decided we haven't had enough demand in our practice yet to do it but as you can see here basically the doctor is it's a less than five minutes surgical procedure but they use a device to basically insert it just under your skin and they leave this this small almost pellet that that is the sensor under your skin and it stays there for 90 days you do still wear something above it so these can go sort of on your flank and the small of your back or the back of your arm and you still have to wear something on the skin above it to sort of read it and send the information but you can actually take it on and off so some people prefer that because they can actually remove the the object on the skin completely so that there's no sign that they're wearing a continuous glucose monitor at all okay so let's talk about insulin pumps and closed-loop so before we dive into this why don't we do some Show and Tell with the pumps so just to give you an idea of what's out there there's really only three pumps available right now one is the t slim so this is a tandem pump it is a touch screen it's a colored touch screen it has a syringe of insulin inside there's tubing that comes off of this and attaches to an infusion set and I'll show you what those look like so this will team up with the Dexcom and so you can see your Dexcom information on here as well as your pump information next I'll show you the tubeless pump so there's one pump on the market that doesn't have to Bing and to some people that's quite appealing that's the omni pod and so this has a sticky backing to it this is actually the pump itself people wear it on the back of their arm or they wear it on their abdomen you fill it on the back you fill it with insulin and then it pumps through a little catheter that sits underneath the skin you wear it for three days you take it off and you put a new one on the controller looks like this and this is where you program your basal insulin rates and your bolus ratios and you would put in your blood sugar tell it how many carbohydrates you're eating it would calculate the dose you would push a button it would send the message to your pump and the pump would deliver that bolus for the insulin right now it's not integrated with any of the CMS but they're frantically working on it and then finally and Aaron's gonna spend more time talking about the 670 G which is the only partially automated pump this is if you remember the slide of the first insulin pump the mini med pump this is the the latest Medtronic pump it has a place where there would be a syringe full of insulin and tubing that will come off of that that will attach them to a infusion set that goes underneath the skin and delivers the insulin this is programmable for your basal insulin you tell it what your blood sugar is just like the tandem and the Omni pot it will calculate the dose and will give it to you this will work with the Guardian sensor and Erin's going to tell you more about how that sensor works it's a CGM but it works together with the pump to determine how much insulin to give last thing to show you is the infusion sets themselves this is our example board but an infusion set looks like that it sits under the skin it's put in there with a needle but it's actually just a plastic cannula that sits under the skin you can disconnect I'm not trying to take the whole thing off you can disconnect it and just leave that there if you wanted to go swimming Lauren take a shower if you wanted to be off of the pump for a short period of time you could do that this then ultimately is the tubing that would then attach to your pump and so that's my pump here so that ultimately then would be the setup for the Medtronic pump with the tubing attached to it all right okay so yes yeah that's a great question so the question for people in the back was do insulin pumps we're talking about them for type 1 diabetes do they also allow you to cover basal insulin or long-acting or do they only have fast-acting insulin and so the the way an insulin pump works is that they are filled only with fast-acting insulin but because they're pumping them into you continuously you are delivering a basal insulin dose so for people who are taking injections they might take two different kinds of insulin one that they inject once or maybe twice a day that covers what we call the basal insulin their basal metabolic rate and is covering you all through the day in sort of a flat mechanism of action and then when you're going to eat you cover yourself for your meals and the food you're gonna eat with fast-acting bolus insulin so with a pump it's dripping in slowly fast-acting insulin all day for the basal rate and then you tell it when you're gonna eat you you punch in you know I'm gonna have 30 grams of carb or 45 grams of carb or 50 grams of carb and my blood sugar is a hundred and forty and it's pre-programmed with the calculations and it will deliver a bolus just like you would be taking a bolus so even there's only even though there's only one kind of insulin actually inside the pump you are getting both the basil and the bolus insulin now I will say that one of the risks of the pump is because you're not actually injecting basal insulin you saw Marlene showed you that there's long tubing and you've got a machine here and as we know machines sometimes do fail and so one of the risks of the pump is that if the cannula site gets clogged or sometimes the cannula bends or the tubing can get clogged or sometimes the pumps have mechanical issues or the battery dies the insulin might stop infusing or not not be able to get into your body and because you don't have long-acting insulin in your system it you have type 1 diabetes it can become an urgent situation more quickly than it does if you're taking injections so they offer a lot of convenience for people if you're an athlete you can you can change your dosing quite quite variably if you want to whereas if you take an injection of long-acting insulin you take one dose that's it for the whole day with these you can change those basal doses up and down through the course of the day so you get a lot more flexibility and there's the calculator built in so it's remembering all of the insulin doses that you're getting it's helping you calculate so there are many benefits to insulin pumps but there are some there are some potential downsides as well that you have to be aware of and at least be careful for if you're using them you want to yeah I think it's just it's a it's another way of delivering insulin and I think that you know for some people it's more of a convenience but truly it's a way of delivering insulin now we have other reasons why people might want to go on to an insulin pump people who never wanted insulin pumps before looking at them again and that's because of this closed loop interaction between the CGM and the pumps that can help to determine it's often very difficult to really figure out how much basal insulin you need during the day more during some parts of the day less during other parts of the day how do you adjust when you exercise how do you adjust when you're working versus at home not being very active to have technology that could actually figure that out for you is really pretty remarkable so people who weren't interested in pumps are are starting to look at them again yeah question here so yeah so I should have mentioned that earlier thank you so the the smart pens I showed earlier actually only do short-acting insulin they don't do long acting insulin yet maybe someday they will but they've not done that yet but it does mitigate some of the issues or some of the reasons that someone might choose a pump over a pen was for the memory and the calculator and the the smart pens for that so for some people who might have chosen an insulin pump for those reasons in the past there might be a little bit less reason to do it in 2019 than there was in the past yeah yeah absolutely so I mentioned the the flexibility you get when you can use an insulin pump with the basal doses giving you the flexibility to turn them on and off and that does better mimic what the body does so when we give you a long-acting shot of insulin we are trying as best we can with the tools we have available to give you a basal dose of insulin that's gonna last you the whole day but in reality the body doesn't work that day right you wake up in the morning you get a surge of adrenaline when you wake up in blood Sugar's off and rise something we call the dawn phenomenon and with a with a long-acting insulin it can be really hard to account for that with an insulin pump you can say okay I'm gonna set my my dose here for some part of the day and then when I wake up in the morning and I know that I'm gonna need extra insulin I can increase the basal rate and just have it preset like that for every day as a female insulin resistance and and insulin needs often change during menses and during the menstrual cycle and so you can actually pre program different settings and different profiles on the insulin pump to account for the changes you might experience before and during a period so so there are lots of other reasons to consider insulin pumps okay so what about closed-loop delivery or the artificial pancreas so when you're using an insulin pump before the world of closed-loop insulin delivery so let's imagine you are wearing a continuous glucose monitor on one part of your body and you're wearing an insulin pump on another so the continuous glucose monitor is measuring your glucose level continuously and you can use the pump to be delivering insulin continuously until 2017 you were the brain in the middle so all of the decisions about how much insulin to give based on what those glucoses were are up to the user so we call that open-loop insulin delivery and so that basically means you're looking at the blood sugars and you're making the determination completely about what to do and how much insulin to give yourself what the closed-loop insulin delivery systems are doing are putting something called a control algorithm it doesn't necessarily need to be a device but it's a control algorithm in the middle and so what that's doing is it's in a computer algorithm that is often built into the it's currently built into the insulin pump but in the future will actually run as an app on your cell phone that knows where you're where it's predicting what your your glucose levels are going to do it's learning from what's happened over the last week what's happened when it's given you a certain amount of insulin how your body reacted what your body's sensitivity or resistance is to insulin you still have to and we'll go into this in a minute but you still have to tell it that you're going to eat you still have to tell it if you're going to exercise so we don't consider this and a fully artificial pancreas because you can't just put these devices on you and walk away there's still a lot of work effort involved but it does provide some autonomous control of your basal rates and your blood sugars and so the the JDRF created these six categories of of the artificial pancreas development and I'll walk through what they all are but I think oftentimes the media will say the artificial pancreas is here and we have to kind of dial that back and explain what what what's really here and what it really means and what we really have so stage zero would be just an insulin pump on its own with you making all of the decisions stage one we had many years ago which is if the glucose level on the continuous glucose monitor got very low the algorithm would say I'm shutting insulin off so it would just shut off your basal insulin if it sense that things were going low Stage two and and what the company tandem has currently and something called basal IQ is predictive low glucose suspend so it doesn't just shut off insulin basal insulin when you go low it actually predicts when you're going to go low and shuts it off trying to prevent the low blood sugar from happening what the 670 G is is really Stage four and we call this hybrid closed loop so 24/7 as long as everything is connected and working as it's supposed to it is adjusting your basal insulin rates completely in the background without you making changes to your basal insulin rates so again you still have to tell it that you're gonna eat you still have to give it your carbohydrates before you eat ideally you're still doing that before you eat to give your body the best chance of using the insulin well for your meal but the basal insulin rates are adjusting continuously in the background what we really want to get to is Stage five and six and that's really when we're getting to fully autonomous insulin delivery we're not there yet and I would say we're still many years away from that happening I'll show you in a minute there is one company that is using dual hormone closed-loop therapy and I'll talk a minute a minute about what that is but they're not available on the market on the market now so the best you can do right now is the 670 G tandem will be coming out hopefully sometime in the next year with what they're calling control IQ which is going to use the same pump but there'll be a software update to let you get hybrid closed-loop that will be similar to what you're getting from Medtronic so the way we think about using these devices today is really like bumper bowling so they are pretty effective at keeping you out of the gutters it is not I took my daughter last weekend you're not gonna get a strike every time so it's really important to have the right expectations and again I think you know the media says artificial pancreas and people think okay it's solved I can plug this thing in and forget about it and you and you really can't you still have a lot of work to do when you're wearing these and so Gary shiner who's a great diabetes educator in Pennsylvania put this slide together and I think we've really found this to be true in our practice the people who seem to benefit the most from the 670 G are people who have relatively regimented lifestyles if you you know have shift work that's very variable from day to day you one time working a night another time working a day it can be very hard for the algorithm to learn what your patterns are because it's only remembering your last seven days this is not it it is advanced but it is not so advanced that it's learning you forever and ever and ever and getting better and better over time it's just remembering your last seven days and so if your lifestyle is erratic it just does not work very well there are still a lot of sort of little technical hiccups it freezes and sometimes asks you for a blood sugar again and again so you do have to be a little bit more on the technical savvy side to use it a lot of people who use insulin pumps traditionally really like to be involved and hands-on and changing their settings and and making changes and that's that's we really like that and we encourage it this device is really not great for people who want to be hands on it is because it's adjusting things in the background we find that people kind of fight it a little bit if if they're too hands-on and the algorithm is trying to do one thing and you're trying to do another and and it can be a little bit complicated anything else you know I think that's probably we do find that some people are having no problems at all everybody everything's great and other people are having all kinds of problems some of the problem is is like Erin said things going on with the sensor and it seems that it happens at night when people are trying to sleep and they get alarm after alarm after alarm and after they've been awake all night finally it says sensor failed and they have to start over again it's a little frustrating but really the even the ones who are most frustrated will say that despite it all it does a better job than what they were doing on their own so I think there are some benefits but it's going into it with the right expectations and not expecting that it is going to be a hands off because it it's learning when to step in and when to step back and that's probably the hardest part of it so who does what when you're using a 670 G so working with your clinician you're gonna set up the carb ratios you're gonna tell it how long you want the insulin to act for and you still have to put in all of those manual mode settings like you might put in an insulin pump normally because it does kick you out of auto mode or sometimes the sensor fails and so you have to have your regular manual mode settings in there the algorithm does to automatically determine your basal rates like I was saying it automatically determines your sensitivity factor and the target is preset at 120 milligrams per deciliter unless you tell it you're exercising when it sets the target to 150 milligrams per deciliter so again for people there are people who want really tight blood sugar control they always want to be 85 this is going to make it impossible because it's gonna be trying to push you higher towards 120 as the user or the patient you still have to do two to four finger stick calibrations per day for Medtronic's sensor so unlike the other sensors they still do require finger stick calibrations and again you still have to tell it if you're gonna eat and how much and put in finger sticks for correctional ballistas there are also some features that people like to use in their insulin pumps that are no longer available so you can't set a temporary basal rate or some people will do something called a square wave or a dual wave bolus with an insulin pump which is if you're eating a very high fat meal and you can no longer have that level of control when you're using the closed loop system so here's what it's doing in action and I want to take a minute to kind of show you as I think this is really fascinating so on top here you're looking at a continuous glucose monitoring tracing from a 670 G user each of these dots are their fingerstick levels and everything else is from the CGM what you're seeing below here in the purple are their insulin boluses so this is telling it that you're eating 30 grams of carbohydrate and it's gonna give 4 point 3 units of insulin but what what the 670 G is really doing are these pink spikes here so this is the the algorithm changing basal insulin rates turning it on and off and on and off in a in a very pulsatile fashion based on so this is the person let's see that's middle-of-the-night so here we are so midnight to 6:00 a.m. you can see that the basal insulin is kind of going on and off and it's keeping the person in a relatively stable blood sugar range which can be really hard to do and then here they ate a meal they took a dose of insulin maybe it wasn't enough the blood sugar got really high and so in trying to compensate the algorithm said whoa we're gonna turn the insulin level way up we're gonna try to bring the person back down and sure enough it did and then it shut itself back on and then sorry shut itself back off and then kept going so there are many hassles and problems these are this is the first generation device as with any first generation device there's lots of issues but you can start to see the promise of how these things can be incredibly impactful incredibly helpful and as future generations come out they're gonna get better and better so one thing I always like to show cuz this is incredibly cool in the diabetes community this is a woman named Dana Lewis she and her now husband Scott Lee brand probably 5 years ago now he was a programmer at Microsoft and she was a woman with type 1 diabetes and they decided there at the time there was no closed-loop insulin delivery system so him being a computer programmer he decided to try hack her insulin pump there's actually been a lot of newspaper stories about them now so he did so he actually wrote an algorithm he hacked her pump he took a small portable computer this was they've gotten a lot smaller now now they fit in like a tic-tac box but they built their own closed-loop insulin delivery system and they're now hundreds of people around the world using this open ApS system and and doing quite quite well they tend to be people who are really you know engineers and good with technology because you still have to build it yourself it's not FDA approved and so it's it's very much people who want to be in control themselves there then came another group of people who decided to take it one step further and built something called loop which actually is an iPhone app that allows you to control the closed loop system on the iPhone app and there are thousands of people around the world I think even hundreds in the Bay Area alone who are using these and have really built their own closed-loop insulin delivery systems so what's been great about this is that they think it's pushed the industry the the actual manufacturers who make these things and get them FDA approved to drive themselves harder and faster to make better technology because I think patients kind of got tired of waiting and took matters into their own hands and really drove the industry forward and I think it's it's a really an inspiring lesson for people who have all sorts of conditions to to push industry to do things better and better so what else is coming in close loops so we mentioned that the tandem closed loop has clinical trials that are ongoing omni pod for people who really don't want the tubing and want to wear a patch pump they are also in clinical trials we don't really know when these are to be expected we constantly hearing different dates but they will be out you know in the next one to two years if they if all goes well and they get FDA approval tidepool i talked just a second ago about the the patients who built their own closed-loop system so JDRF actually decided to push forward something called the open protocol insulin delivery in in 2017 and what they're trying to do is allow patients to choose their own components and piece them together to build a closed-loop insulin delivery system so today when you use the Medtronic system it's a little bit more like at the Apple ecosystem where everything you have to use has to be Apple to talk to each other so you have to use the Medtronic sensor you have to use the Medtronic pump you have to use the Medtronic algorithm and they all work together as a system what this is doing is really breaking that apart and and saying you might want to choose one manufacturers continuous glucose monitor and another manufacturers pump and an algorithm or an app that goes on your phone from somebody else and so the FDA along with JDRF is actually trying to create that kind of an interoperable ecosystem where you can choose and mix and match devices together so tidepool as a company is actually going to try to commercialize and go through the FDA to get that loop iPhone app approved yeah I just to get some information I don't want any insulin I have been known to have bulimia and I just want some information so I can figure out yeah so for for a sort of short term just want to learn a little bit more I think that's where the Libre really comes in well Dexcom can be very expensive requires a lot of insurance authorizations and when you get a Libre as I sort of mentioned earlier you can just get one for 14 days where it gets 14 days worth of information pay one time not a lot of expensive equipment to go along with it and get a lot of information so as you can see there's a couple of more companies working on on closed-loop insulin delivery and so there will be a lot more options coming for it in the years so I think the big you know if you're gonna walk away from here with a couple of big picture lessons I think one is to start thinking beyond the a1c a1c is still a very important measure and we we still check it and but there is a lot more information out there to be had and so for a lot of people the a1c alone is not enough who should be getting continuous glucose monitoring I think everyone who has type 1 diabetes should wear a continuous glucose monitor I think probably many or most people who have type 2 diabetes would benefit even just from a short 14-day where maybe don't need it all the time but could learn a lot of really helpful information about themselves and their blood Sugar's I also think there are some people who might have other risk factors if you have a family history if you've got a woman who's going to be getting pregnant and has a family history of diabetes and is at risk I think there are other people who might benefit from a short wear of a continuous glucose monitoring there isn't really yet a lot of clinical trials or information on that but I think it's relatively low risk and might provide some benefit with people again there's a lot more emerging options for mobile connected coaching services so there are I showed that slide with a lot of different companies and I think you get the slides online so you can go back and look there's a lot of companies now who will let you sign up for a monthly fee and provide coaching online and as we just talked about a lot more options coming and closed-loop insulin delivery for people with type 1 diabetes so I always like to end with my my my far away prediction so here's where I think by 2025 this is where I think things will be so I think if you have type 2 diabetes I think finger sticks will be gone I think for many people that that may happen even sooner but I think continuous glucose monitoring is going to get smaller cheaper easier and the days of really painful finger pricking will soon be over yeah I think we'll have a lot more options around virtual care and remote coaching so that there will be you know some whether it's a person or an algorithm helping to actually coach you based on what your data is continuously I think same thing for type 1 diabetes I think finger sticks will be essentially gone I think continuous glucose monitors will last much longer than they do 10 or 14 days the same thing they will get smaller and cheaper and we're gonna get much closer to autonomous closed-loop insulin delivery in the next 5 years will we get to fully autonomous in five years maybe maybe not but we'll be much closer to it than we are today and I think for people with type 1 diabetes and I already do this in my own practice I look much more at those time and range metrics and what your blood Sugar's are then what your what your hemoglobin a1c is and so I think a really important thing to take away here is if you are someone who's using insulin and you're working with a clinician and all they're talking about is a1c I would say push them to think about continuous glucose monitoring and about looking in more detail at the data to see if you might be having high blood Sugar's and low blood sugars and if you might be able to learn a lot more than you do just from an a1c so with that we are happy to take lots of questions yes so it's a great question so the question is as things are up and running you know you've got connected devices what is the role of the clinical team it's changing so most most medical centers most doctors offices were set up to have you come in every three months get an a1c you know maybe look at your logbook with your finger sticks and all of a sudden you've got hundreds of thousands of continuous glucose monitoring data points coming in and so we're trying to change the way we deliver care we do use the the websites that I showed you to look at the data we don't yet have you know I think where we'd ideally like to get to is sort of like a a tiered system where maybe the first stop is is the computer gets smart enough to kind of be watching you all the time and you know sort of do a check engine light kind of thing and if something's wrong then maybe there's a clinician who looks at that information and then you come in to meet with your team to actually like do your your big check up your big maintenance every once in a while it's gonna take time for the delivery of the healthcare delivery system to move in that direction and so we're not you know we're not there yet but we're slowly over time moving that way yeah so I am so grateful you asked that question so the question was is there any animosity between the medical community and the companies building these devices so on one hand I would say no I think they are doing their best to create devices that are that are useful for patients we wish they would go faster you know just like anything else and make things better more quickly there is one place where I do have some animosity and I'm more than happy to have all of you become advocates for this so there was a law passed in 2016 called the 21st century cures Act that gives every person in the United States the right to have access to their health information and so UCSF and other medical centers it just in the last year we have well you can now actually on your iPhone or from other places you can go download your health information or the basic parts of your health information from your electronic health record it is your legal right and we've connected it so that you can go do that it is not the same for these device companies so they are not under any that the law did not yet apply to them so they're not currently under any legal mandate to give you access to the data from your device so most of them will provide their own software for you to use and go look at it but if you want to go use a different software if you wanted to pull it into something like Apple health or there are there are others but Apple health is really the the largest one there are some companies so Dexcom for example allows you to do that but there are others who don't and so I think it's important for everyone here to speak up about that you know write your Congress people and and tell them that you think the 21st century cures Act should apply to the device manufacturers as well yeah as a physician how do you feel quality that these devices collect compared to a finger stick yeah yeah certainty you know certain reliability that so it depends on the device so they're getting better so one of the slides I showed had a number called the ma Rd and that more or less is showing you the error rate of the of the devices it's how accurate they are compared to the finger sticks a few years ago those ma RDS were up in the thirteen fourteen fifteen percent ranges they're now down to about eight or nine percent so they're getting much better one thing that's really important to say is that the continuous glucose monitors because they're sitting in the subcutaneous tissue they're not actually reading blood so the finger stick is getting blood and that is really the source of truth for what is your blood sugar these are reading sub interstitial fluid in the fat and there is a lag time so a lot of times people come in and they say I looked at my CGM number and then I checked my finger stick and they're not the same and it sometimes it's because the CGM may not be perfectly accurate but sometimes it's just because there is a lag and it's expected and so at the end of the day the the the true number is or the closest thing to the true number is a is a blood sugar there are still a lot of accuracy problems though even with finger sticks so finger sticks remember if your finger might have food on it isn't perfectly clean there are a lot of people who are buying strips off the internet test strips off the internet that might you know not be manufactured properly or might have sat in a warehouse that was hot and so we've come to believe that finger sticks are perfect they're really not it's really a lab blood sugar is the is the gold standard finger sticks do pretty well and see GM's are doing almost as well as blood sugars as a finger stick but you're also getting so much more information that even if the accuracy is a little less good I think it's kind of over by how much more information you get I agree I think we were so used to looking at these points in time of the finger stick readings now we're trying to refocus and look more at what's the trend and what's the pattern does this happen every day is this something that we can change I think that we're we're kind of getting away from that single point in time so our minds are changing you can essentially almost 100% prevent hypoglycemia the two extreme huh at least I can so if you're paying attention to those arrows on your seat on your PDF it gives even if it's not actually precise you can prevent impending low blood sugar yeah amazing points in time so I also teach my patients to look and they say oh that's oh my finger sticks at this and my CGM said this isn't accurate and so you have to kind of relearn that the directional arrows give you so much more information so you re teaching people all the time about the meaning of their information yeah absolutely cuz you know a blood sugar of 120 without you know with where it's predicting that you're you're staying the same is very different from 120 rising rapidly is very different from 120 falling quickly the way you might think about those and approach them are all very different and so completely agree that it's a reframing of the way you think about it so I wanted to just get back to the lady over here who asked the question so we don't miss her her so her question was about piecing together your own pump insulin pump versus using one that's FDA approved and on the market yeah so yeah the components are pretty cheap so the I mean you know you're buying so if they all use a Dexcom CGM so you're paying like you would for a Dexcom CGM currently they the the systems use a very old Medtronic pump that people have figured out how to hack and those can be very expensive because they've gotten rarer and rarer so they're sort of on eBay and places like that and I think I think they used to be cheaper but they've the price has been driven up quite a lot the the components that sit in the middle or I think 100 or 200 bucks for yeah the Riley link computer it's like a tiny computer that are that are relatively cheap and then the hack people are willing to go and show you how to actually do the hack I mean this is a really open community so if ya people are willing to show you how to do the programming how to do the hacking into the system it's just that those pumps used to be valueless they're old they used to be zero sorry Kyle they used to be like valueless these old pumps because they were third generation you know three generations ago but now there's a black market for them unfortunately so you have to have resources to get the pump the old pump attack yeah so what the a1c is is your your red blood cells have hemoglobin in them and the a1c is looking at how much glucose attaches to the hemoglobin your your red blood cells live on average about ninety sometimes 120 days but around 90 days and so the blood test is measuring the average amount of glucose stuck to your red blood cells and because the red blood cells live about 90 days it's about a 90 day average so any disease actually that changes your red blood cells can impact the accuracy of the a1c so if you get a blood transfusion if you have chronic kidney disease that can sometimes affect your red blood cells if you have certain types of anemia it can affect your red blood cells so so really anything that can impact how long your red blood cells live or the shape of the red blood cells can sort of impact the accuracy of the test sure yeah so the question is with all this technology why haven't we seen something that is all encompassing one box easy to use I think there are companies that are trying to get there I think it's just still very early so for example all of the closed the closed loop systems that are in development right now or at least close to the market still require a separate site for the CGM sensor and for the insulin pump I know there's been a lot of thinking and testing using one puncture or one site to do it but no company has really figured that out quite yet so I think one thing would be getting getting same site insulin delivery and continuous glucose monitoring the other piece is really about the software and and just making things easy to use and I think honestly part of the problem is that closed-loop insulin delivery systems are built for the type 1 diabetes market which from a financial perspective is as small as these big drug companies look at this it's a pretty small market and so there's not enough of a financial incentive you know you've got just a few companies who are making these things and so there's not as much competition as say in the auto industry or these other industries where there's a lot of competition and really big dollars to drive companies to make really great consumer products there's not been that drive in in the type 1 world yeah so it's a great question so question is about if you have type 1 diabetes can you use a libre so my general rule is it's better than nothing but I prefer I recommend people use a true continuous glucose monitor so Marlene was was showing and talking about the libre is not actually transmitting your blood sugars in real time so even though it's gathering them you have to actually take something and scan it to get your reading and so one problem with type 1 is you might get a low blood sugar and not realize it this often happens in the middle of the night but it can happen during exercise in any time of day and the other continues the truly continuous glucose monitors will send you an alert and and your phone will beep or vibrate or the device will vibrate and warn you and alert you that that's happening and the liebre doesn't yet do that I believe they're next generations probably will but so for me that's a very important function and so for me I really recommend people with type 1 don't use a Libre but if people have have reasons why they don't want to use one of the other ones it's absolutely still better to use a Libre than then something else than finger sticks yeah doctor 19 works with adults and I work with teenagers oh yes so the Libre has been really amazing for my teenagers who have what I call alarm fatigue so when you wear see GM's we try to make the alarm as infrequent as possible with teenagers whereas I might have tons of alarms on mine to let me know when I'm going up and I'm going down my adolescence with diabetes they get they just don't want to be alarmed in the middle of class they're embarrassed they put it on vibrate they start ignoring their alarms and so the Libre is an option they give up on their sensors they take them off they refuse to wear them they think they take a hammer and they crash their transmitters they've done all kinds of things so the Libre is a step where they have the power to choose when to look at the blood sugar now they still need to look at that blood sugar at least three times a day in order to make to sink to get the continuous feed so you have to actually wand the Libre three times a day and then it connects all 24 hours of data so we work with them to try to get them to interact with their data at least three times a day more is better of course but I'm finding that the adolescents I put on libras are then getting more data than they were on finger sticks which is like sometimes one every other day I mean they get they get burnt out very easily because of their developmental stage so and that happens with some adults they don't want the they don't want the alarm fatigue they don't want the constant alarming and so they want to be in in in in control of when they're engaging with the data so for with it yeah all right so we have the devices up here thank you so much for your attention and your great questions is really fine [Applause] [Music] you
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Channel: University of California Television (UCTV)
Views: 10,026
Rating: undefined out of 5
Keywords: continuous glucose monitor, diabetes
Id: ai7CIqY51p0
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Length: 74min 45sec (4485 seconds)
Published: Wed May 15 2019
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