Pediatric endocrinologist Gina Capodanno, MD, explains differences in diabetes between children and adults, then presents a thorough guide to the technologies – continuous glucose monitors, insulin pumps, and hybrid monitor-and-delivery systems – that are making life easier for families. She gives specifics on available options, reviews disadvantages as well as advantages, and offers tables showing age-appropriate devices. She also discusses staving off management burnout in kids with diabetes and their parents.
Well, thank you so much for inviting me to this webinar series. Very excited to talk about advances in pediatric diabetes, focusing on diabetes technologies and management management strategies primarily of type one diabetes. So some of the objectives are to, by the end of this talk described how the management of Type one and type two different Children versus adults describe some of the management advances and device technologies used in pediatric diabetes management identify the day to day challenges the families. Navigating new pediatric diabetes device technologies and identifying the factors leading to diabetes burnout in Children and adolescents and some strategies for support. So just kind of starting with some background here that, you know, the diagnostic criteria for clinical diabetes hasn't changed. It's the same in kids and adults. Normal fasting blood sugar, less than 100 impaired is between 101 25 1 26 or higher as diabetes and random blood sugar or post O. G. T. T. Less than 100 and 40 is normal. 1 41 99 is impaired and 200 or higher is diabetes. And you know, hemoglobin. A one C. It's used a lot in adults. It's increasingly being used in pediatrics though confirming with impaired fasting and random glucose across two checks or having a clearly defining event like DK is still the gold standard. Most pediatric diabetes can be classified into either type one which is autoimmune mediated or type two due to insulin resistance and type one is over six times more common in youth um with peaks in early childhood and adolescence but it can occur at any age and it's important to note the presence of obesity does not preclude the diagnosis of Type one. Really any pre puberty, all child, regardless of habitat, should be assumed to have Type one. Um the rates also of both. Type one and type two diabetes in youth are going up from 2001 to 2017. As presented by the search for diabetes in youth study showed the prevalence of Type one in ages 19 or younger increased from 1.5 to 2 per 1000, with the relative increase of 45% over the 16 years and of type two and age 10 through 19 increased from 190.352 point 46 per 1000 with a relative increase of 95% and greatest absolute increases seen in non hispanic, black and hispanic youth Like many disease processes. Type one is about to manifest through to hit mechanism. The first being a genetic predisposition. The second being an inciting event like a viral illness, a stressor leading to immunological abnormalities and a progressive decrease in beta cell mass. As beta cells continue to decline until they reach a critical point where insulin releases affected you initially with normal glucose. Then as c peptide starts to decline. This is where disguised femia occurs and the symptoms of diabetes are seen. The designation of Type one is now broadened to include states of normal glucose before disguised Tamia is seen. So here just kind of another representation of that same idea. The american diabetes association uh juvenile diabetes research foundation and the endocrine society support a new stage process of type one diabetes development by having two or more pancreatic antibody's positive puts an individual on the path to type one diabetes. So stage one is to antibodies positive with normal glucose. You have stage one. Type one diabetes, Stage two is two antibodies positive with abnormal glucose when that dis regulated range and stage three is antibody positive with the clinical diagnosis. So that's where we're usually seeing more. You know, traditionally people presenting with diabetes but now patients are coming to us at this stage and to you earlier with mildly abnormal even or even normal glucose. But on the pathway to diabetes. Trial net um provides family members of people with diabetes free antibody testing via either home home finger stick kits or serum lab draws request or lab core Czech five antibodies Um and if it's all negative, the individual is unlikely to develop type one diabetes. And if one antibodies positive, yearly um re screens are offered and then to positive you have diabetes, it's just waiting to happen. Type two diabetes and youth is felt to be an aggressive process. Also rooted in genetics with overlying metabolic factors contributing to the pathogenesis compared to adults. Children and adolescents with impaired glucose tolerance. Have decreased insulin sensitivity and increased c peptide response measured by hyper glycemic clamp. And this beta cell hyper response represents a fundamental difference in the physiology of disconnection between youth and adults. And it may explain the different rates with which diabetes develops and progresses in youth and adults with increased demand on beta cells leading to a more rapid loss of insulin secretary function. There's a couple of points on type two and then we'll switch gears. You know, like I said, Type two is a much more aggressive entity um in youth than in adults with increased susceptibility to early onset complications, lifestyle management. Um And Metformin remain first line for management and we more aggressively titrate to max dose of Metformin really early on and stay at that dose with the recent 2019 FDA approval for Victoza or lyric low tide injection for treatment of pediatric patients 10 years or older with type two diabetes GLP one receptor agonists have really become a standard part of management for patients um with a one C in that 7 to 8 range before for the introduction of insulin is needed. Um So here's just a little diagram of GLP ones, you know, they have multiple effects on the body with direct effects on the stomach islets, liver. They slow down gastric emptying increased insulin secretion and sensitivity. Help with appetite and satiety. And so really just to kind of sum up Type two we've got lifestyle which always always always needs to be part of the picture. And we've got Metformin GLP ones and insulin. So fond of juries have limited use in neonatal diabetes and modi but really other categories of anti hypoglycemic agents are not approved. Nor have they been shown to be a benefit free abuse For patients under the age of 18. So I'm moving on. The bulk of the talk is going to be going through diabetes technologies. Um I'm going to divide it up into some monitoring tools. Insulin delivery, glucose responsive systems and apps and software. I don't have anything to disclose. I have no affiliation with any manufacturers or developers, but I do need to kind of talk through some of the um specific devices just because they have different interfaces and it's important to know you, you know, your patients have all of these things. So um kind of seeing them, understanding how they work is really important. So glue commenters, you know, basic always going to be important. Everyone need with diabetes needs to have one. Even with some of the other glucose monitoring tools are needed for backup in some cases, calibration of other devices. We've got numerous brands need three prescriptions. The meter test strips and Lance it's or the poker. Um, conventional meters. These are uh usually the strips are covered by insurance data is is downloadable to a web app with a cable. Um, and just kind of a point on that. Um, you know, even with conventional meters, you can use alternate sites. Each brand has different approved sites like the forearm, thigh or calf. And I just found that that that could be helpful for patients either with extremity lymphedema, rain odds or digit amputation. So kind of a neat thing that increasingly even just kind of conventional meters. Um, you don't have to use the finger um to get a good glucose read. Um, connected meters. These are the newer ones connect via bluetooth to a smartphone or an app. Um some can directly link to a pump. Um and so patients don't have to manually entering glucose for dozing and these supplies are less likely to be covered by insurance. Um, home blood ketone meters are also a useful tool. They also involved a finger prick, require separate ketone meter and test strips. These are different than the glucose test strips and then lance. It's which can be the same as if you, you know, poke your finger for glucose check. These are useful for type one and in some cases type to either with the history of DK or on certain 18 plus uh medications. Um, ketone detection via blood is faster lets you know right now how high ketones are versus urine, which can take up to six hours to detect true positivity in the blood. Um, so it gives you kind of that real time information here and I put the key along the top, right on what's normal is less than 0.6 and above 1.5 is is high. Um so newer meters can check both ketones and glucose. You can just kind of use that one device but you still need separate strips for blood. Um uh for the ketones versus the glucose. Uh they're less likely to be covered by insurance and the strips for ketones are really expensive um usually on the order of magnitude of one strip, $10. So it really does put a financial burden with it. But it gives great information, continuous glucose monitors or C. G. M. One of the major advances in diabetes technologies, um although not for everyone. Um many of us introduced them to our new onset type one patients almost immediately As they really have changed the course of diabetes management for patients who now don't have to prick their finger 8-10 times a day for glucose data. The first professional C. G. M. Was introduced in 1999 and then early home version started to be available around 2013 to adult patients with some lag by a few years to the younger patients, but really not until 2018 were they more ubiquitously available for patients age two and older. So see GM provides a semi continuous management of interstitial Fluid glucose every 1-5 minutes. It allows you in most cases to see data in real time to help make treatment decisions and can be used for any type of diabetes regardless of treatment regimen does require prior authorization. So it is not universally covered by insurance. Um The three components and then put diagram on here just to kind of visualize it. There is a sensor um that is what detects the changes in glucose. This is a small flexible probe that sits in the interstitial space. It's like just a fraction of a millimeter kind of like hair thin that just kind of sits right under there. Um Then you have the transmitter which may be a fixed directly to the sensor or detached above the skin, just above the sensor that sends a signal from the sensor to display device or receiver. Um And that receiver is usually a separate device but newer models can display directly on the pump or connect to a smartphone or watch. And the receiver provides the user then with the ability to review past and present glucose trends. The two types of C. G. M. R. Real time and intermittently scanned or flash. Um There's also a professional form that was usually used more before these came out to be for home use. Um That the provider would would use kind of for using as a as a treatment um discussion with patients but it was blinded and the user didn't have any of that real time information but those are kind of less used now in the ones that are at her home a real time are intermittently scanned. So real time shows an automatic display of data has alarms to alert the user of high and low glucose levels And flash shows a few hours of continuous data when the user wants it. By by scanning uh manually of the sensor sensors can either be inserted by the user. So conventionally subcutaneous lee with an insertion device, little plastic tube that you just kind of click in a minute, puts it on the skin. That's the most common. Or by the health care provider um implanted under the skin. Um just a couple of practical aspects. I'm gonna zip through here. So we said, that's got alarms. You can see high and low glucose levels rise and fall rates. There are predictive alerts, trend graphs, arrows. Real time intervention can be done because you're you're seeing things right here right now and then you can download and review reports that the provider and families also can kind of use to look at patterns and trends and and help to make adjustments. So the two current CGM systems that are out on the market in the US that integrate with insulin pumps are dex calm and Medtronic and the decks com G six Medtronic Guardian three. Both are real time sensors about half an inch thick uh fixed to the skin with the sensor filament. Um like I said that the less than half of a millimeter inserted transmute painlessly. Um The decks com sensor last 10 days. It's FDA approved to be used in lieu of finger stick checks and make insulin treatment decisions. Um With it does not need calibration so you don't need to have a separate meter too. You know periodically check and connect the two. Um Which is really great. And it does have a share feature with up to 10 people through the decks com share app. The medtronic sensor last seven days Does need finger stick calibration during warmup periods with a new transmitter or a new sensor. And then every 12 hours. Both sensors have similar approved locations for placement um on the abdomen, both for adults and Children, upper buttocks for toddlers um and younger Children. And then the arms are kind of as you get older. Um 14 and above. For Medtronic 18 and above for dex calm. So you'll often see uh patients put the sensors in non approved sites um thigh lower back arms and the Children or may not work. And that you know, families are aware that they're using non approved sites. The freestyle libre is a flash system. Um the sensor and transmitter integrated as one, it's a third of the thickness of the others about the size of a quarter measures glucose every minute and stores readings every 15 minutes showing eight hours of glucose history with each swipe of the reader. And the newest model does have the option of real time data and alarms. It does not need calibration. The ever since um is an implantable device approved for age 18 and older. So we don't see that too much in our clinics here. Um And it the sensor is implantable and the transmitter is that big black thing that is removable um that sits on top of the skin with a with the little fixed patch that you changed out daily. Um and then the sensor sends data to the transmitter every five minutes. It communicates to the user of your body vibrating alerts and then to your mobile device via bluetooth. None of these have pump integration, the freestyle libre as as the flash option. You know, it's really good for somebody who doesn't want like alarms and likes that data on demand, like a meter where it's like when it's on it's on and when it's off it's often you have control about what you want to see and when. Um And so that's it is it is still you know pretty common one that we use and both of these are approved for use on the arm only and just wanted to show like the upper picture there that shows the freestyle libra. You can see that the user is holding a scanner there. It's not just to kind of show that it's you know in that area but that's how you get the data. You use this scanner either with your phone if you set that up that way or this secondary device that you can just kind of like swipe over the sensor and then it'll display your data um for the previous several hours and you can see that then in real time. Uh So you know, see GM has played a major role in improving diabetes care over the last five years. It's eliminated the need for multiple finger sticks per day. Um even in those systems requiring calibration, the number of finger sticks is minimal, minimal, which is really huge for our patients. Um It provides alarms for high and low glucose levels so patients can plan and act before having a severe event. Many of our families have fear of overnight hypoglycemia. Um they'll over treat before bed, have rebound hyperglycemia be high all night, you know, stay up all night. So C. G. M really helps with this. It gives parents peace of mind about the direction of glucose levels. Alarms can be set at different thresholds, um different volumes and really just allows everyone to sleep. Just kind of knowing that the alerts are going to come off if if something is running into trouble. Um CGM as I said shows trends instead of snapshots in time. I mean you could have several glucose checks if somebody, you know doing a finger poke, you know three times a day but you don't know how to connect that data. Are they dropping low before they're coming back up into the normal range or they saying hi hi hi hi hi and then you know, dropping rapidly or is it just kind of a steady rise so it gives context to that. Um It can guide on insulin adjustments, dozing strategies and then you know, there's this increasing integration with pumps um which is which is really huge as well. Um some of the disadvantages more with older systems, there were limits on accuracy, especially in the hypoglycemic range. Um you know, some systems still do require calibration for optimal performance and you know, there is a little bit of a lag between that interstitial and capillary glucose. It is you know, narrowing as the technologies are improving but it it can be on the order of about 25 minutes. Um So with the sensor lagging behind um there can be an overreliance on data leading to more issues, especially when you're off of C. G. M. Not keeping up with glucose checks or dozing less frequently just because you're so reliant on the cd, I'm always doing everything for you. So it can be kind of hard to to get back to the group of things. You know, if you're off of the C. G. M. You know, waiting for supplies or just kind of wanting to take a break. It could be alarm fatigue, more skin reactions, limited space on the or body fat for placement, especially in our littler kids and you're on a pump in a sensor. I mean there's just so much real estate that you have to put all these things on the body and then psychological effects of wearing something always on the body. Not just feeling it but getting anxious with insertions or getting unwanted attention. You know because it's there had you know had a patient say that you know he was being teased. People are calling him robot boy because he had so many things on his body. So that that that's huge. The device, anxiety and psychological effects I think are some of the major reasons why some some of our kids will take a break from it. Um or you know really have to balance those psychological effects. So who is a candidate for C. G. M. In short really anyone with Type one diabetes we've got a D. A. Support using language in their standards of care. That real time data helps to lower A one C. And reduce hypoglycemia. Flash data is safe and can replace finger stick monitoring and there's a lot of data to support all of this. Um for type two. Not enough data for universal support. Um but they do say it can be considered in individuals requiring frequent blood glucose monitoring. Similar support from spotted the International Society for Pediatric and adolescent diabetes consensus guidelines advocating for use in all patients with Type one praising its benefits. Um And You know kind of using some of the same things talking about it lowers a one C keeps you more in range um reduces hypoglycemia. Um but in type two diabetes it's still being investigated. So moving on so that's all the data collection. Um Moving on to insulin delivery pens and ports can be helpful for patients on injections. So there is the smart pen which is a reusable injector pen with a smartphone app. The in pen um is the one that's out on the market right now. It was a small company recently acquired by Medtronic. Um It uses pre filled cartridges. So insulin you know can come in a pen to come in a vial or cartridge. Um and those cartridges either human log or NovoLOG or their generics um you know link with a certain pen. So you have to know which insulin there on because the different pen matches with the different cartridge. Um and you put the cartridge in the pen and through the app program targets carburettor Chios correction factors for different times in the day. And then the app calculates your dose. You know, can show you trends, give you reminders it's got an insulin on board calculator to subtract some insulin if the dose was just given thinking about the insulin degradation curve. So that really is helpful to prevent stacking. Um and kind of uses some of the ideas of an insulin pump just built into the app, you know and a pen and like I said it provides reminders and alerts notifications and reports to the user and also from a provider standpoint the data can be downloaded into the clinic to show user dozing, which is huge because I feel like when somebody's on injections you never really know exactly how things are being calculated how often that they're giving the insulin when um and so you can really link that up, especially if they're on some continuous glucose monitoring um tool. So that's a smart pen. Um The injection ports also um put out by medtronic is effectively the insertion set of a pump minus the pump. So you've got this little stick Keyport um that's placed on top of the skin with a little cannula underneath and users can put the syringe through the ports without having to puncture the skin with each shot. And it's a good bridge before a pump. You know, somebody who's older who's kind of trying to see if this is a pump is something that they want to do um for somebody who needs a pump break. Um and it is replaced every three days. Um So insulin pumps, you know, They're really, really common for type one management. It's a small computerized device worn on the body that delivers continuous and customized doses of rapid acting insulin 24 hours a day that mimics the body's normal release of insulin. So important, there's no use of long acting insulin when you're on a pump. Um just that fast acting that's delivered in two ways via basil and bolus. So you're going to hear the terminology. a lot basal bolus basil is the background dose that's provided continuously and expressed in units per hour. It's customizable. So you could theoretically have you know different basil rate every hour of the day if you wanted. Um As I said the basil dozing kind of replaces that long acting insulin injection. Um And I'll say basil customization is really helpful in pediatrics as different ages have different basil needs at different times of the day. For example teens you know with all of their surge of hormones in the morning, you know have like an exaggerated don phenomenon. And so I really need to blast them with higher basal rates. You know first thing in the morning before they wake up and and kind of threw breakfast time versus toddlers have a high late night basil requirement, you know during those first hours of sleep anytime somebody's going through a growth spurt, they'll need some higher basal rates um During those first two hours of the night time and then with you know toddlers to right after that big surge, they really go low overnight. So you need the basal rate to really really really go down. So it's helpful to be able to customize those for you know different ages and stages. Um Boulis is our surge doses of insulin delivered by the patient around mealtime snacks and for high glucose levels. Um And like I said, you know before, you know some pumps now integrate with C. G. M. Known as sensor augmented pump therapy for for additional features. So this is just kind of showing you what basal bolus therapy is. The goal is to try to mimic normal physiology. So here's the graph of physiologic insulin secretion overlaid with insulin action that we're trying to achieve with an multiple daily injection regimen. So that basil insulin is that orange line on the covers kind of your background needs for glucose control overnight in between meals. It's achieved through 1 to 2 shots a day of long acting insulin. And then these bullets this come in and blue for mealtime carbohydrate coverage snacks and just at other times as well if you kind of spaced appropriately for high blood sugar to bring it down into range and that's delivered by the multiple injections of rapid acting insulin with the pump we're using that same principle but delivering the basil rate by a continuous rap rapid acting infusion. Um Like I said units per hour. That's given continuously which is that green line going up and down different times in the day and then user inputted carbohydrate and high blood sugar. Dozing via palaces. So summary of the basal bolus delivery with highlighting some other features um insulin duration time. So this is something that you can customize on a pump. It's usually entered between two and four hours. So how much how long that insulin is going to stay in the system. Um And it allows the pump to calculate insulin on board. Um So how much insulin is presumed to be still in the body from the last dose that was given and it's automatically adjusted them. So the user puts in, you know, blood sugar, carbohydrate information and the calculator, the instant onboard calculator will automatically subtract how much insulin is already still, you know, thought to be, you know, doing this thing. And that really helps to prevent insulin stacking or overdosing the insulin just by kind of giving frequent frequent doses. So insulin duration times, it's that that's the same feature that's in the in pen. Um is is that major principle in a pump, reverse calculation. It so subtracts insulin from a bolus. If the user enters a blood sugar that's below a certain threshold. So if they have that reverse calculating on And low threshold, um you know, say 95 and you're just kind of teaching, you know, your your patient just always to put blood sugar in those for your carbs, blood sugar and just for your carbs and if they put in a blood sugar of 87. you still want them to get that dose for the carbs. But it will subtract a little bit because the in the blood sugar that was entered was lower than that threshold. So it's really helpful to just kind of give a little bit less when the blood sugar is already on the way down temporary basal rates. Um These allow over and under rides of the background insulin like for illness or activity. You know you've got an illness, you have just higher insulin requirements. You can override it by a temporary rate plus a certain percent just to kind of give them that extra insulin that they need um during that susceptible period or activity. You don't need as much insulin really insulin sensitive. So you can decrease the basal rate again just by going down by a certain percentage for a certain period of time. And then extended Wallace's. These allow users to not just get that bullets all at once. Um but to give some of it up front and then the rest of it delivered later or over an extended period of time. Which really helps with kind of different heavier foods. Maybe that aren't absorbed right away. But you still need a lot of insulin, it'll just spread it out. Um give that insulin over a period of time so they don't crash and then go high later. So these are the parts of a conventional insulin pump. There's an infusion set which is that little round um sticker that you see in the top right with a small cannula that's inserted into the subcutaneous tissue. The pump connects by plastic tubing to the infusion set and then insulin flows from the pump reservoir through the tubing to the infusion set. Um It allows the user this whole system to disconnect the pump while leaving the set in place. So the set with the cannula under the scent skin stays there is like a little sticker and then the tubing and the actual pump itself can be removed. Like if if the individual is going to go swimming or take a take a shower. Um The sets Must be changed at least every 2-3 days. So the three commercially available pumps in the US include two conventional pumps. Um uh tandem T slim and the Medtronic Committee Med. And then there's one patch pump called omni pod tandem has a slim design with a touch screen. It's a little smaller than a smart smartphone. Um It has a rechargeable battery and minimally water resistant. We use this a lot in in pediatrics because it allows for the smallest insulin delivery of all the pumps. You can program a minimum basal rate of 0.1 unit per hour tight. Tradable to the nearest 0.1 units per hour, and a minimum basil of 0.5 units thai tradable to the nearest point oh one units. Really tiny doses. It really comes in handy for Toddlers. Um no, your patients who are diagnosed between nine and 12 months. So really, really tiny dose that you just cannot get through injections unless you dilute the insulin. Let me still put sometimes diluted insulin in the pumps. Um Medtronic um has a larger design durable about the size of an old ipod um uses physical buttons and double A batteries. Um it's waterproof down to 12 ft, does have a spanish language option. Um and both of these do have um, CGM integration. The the omni pod is a patch pump. Um it consists of a wireless disposable unit, the pod that attaches to the skin and then a remote PDM personal diabetes manager to control settings and dozing. So it's nice. They're totally disconnected. Um it's great, you know, overnight the parents can control the PDM and deliver insulin kind of on demand while the child is sleeping and not having to come near the child. Um, so with this, the diagram on the bottom, you see the insulin reservoir is filled by putting the insulin in a pod with the sticker is placed on the skin. The PDM auto primes um gets rid of the air bubbles inside the pod. You press the start button and 1 2/100 of a second that cannula is auto inserted under the skin. There's no tubing. It's waterproof, changed out every three days max. These are the two Omni parts that are out right now. Eros is the classic dash is the newer one that imminently is coming out with um, see gM uh, integration. So really eagerly waiting waiting for that to come out. Um, but that, that classic pod system. The PDM has physical buttons. Um it's nice. It does have an integrated group kilometer. So along the bottom there underneath the buttons there is a place to put in a test strip so you can just use that. You don't have to carry a separate glue commoner. Um and then that dash is the newer one. It's a smaller pod thinner. Um uh There is a touch screen PDM using an android body device. Um It has a little bit more customization and see GM visibility. Um So those are the two that are out big picture with pumps. Um They take away the need for multiple daily injections and provide really flexibility. Very fine tune tuning in a very small doses of insulin which is great. Like I said for little patients there's only one insulin. You don't have to have multiple types of insulin. Get that confusion of giving the wrong one. We said that there's that insulin duration and bullets calculators to take away the math. Which can sometimes get overwhelming and confusing from the user. There's large customization, you've got those advanced features and then integration with C. G. M. But still you know it doesn't do everything. Um You still need to carb count and dose for food. Um You need to put in your blood sugars and dose for those. Um There is a risk of skin infections. You know easy lipo hypertrophy from that continuous infusion just causes more inflammation. More easy DK if that cannuLA is kinked or becomes dislodged. You know there's no background insulin going on. So so the insulin is out of the system, it's out and so kids can build up ketones really quickly. Um If that something happens with that pump device and then you know the risk of hyperglycemia. Um Similar to C. G. M. Since it's a device on the body, it can be knocked off. It can cause pain anxiety and wanted attention. And so who's a candidate for an insulin pump? Similar to C. G. M. Really, anyone with type one diabetes supported by the A. D. A. In this pod? Um Type two still under question. So kind of putting things together. Now a lot of individuals have both the pump and CGM. Um there are systems that are coupled integrated together so um that can display information to the user. An open loop A sensor augmented pump is where traditionally there were two separate devices. The pump delivers insulin and the C. D. M. Looks at glucose levels and the two don't connect. They don't talk to each other. Um Open loop they that insulin dose and software operates independently requires input from the user versus the direction that we're moving towards. These are these closed loop systems where the insulin dosing software and the sea GMR coupled so via the pump and CGM with the control algorithm, automatic adjustment of insulin delivery is done and this is this pathway to the artificial pancreas system. Okay so we have moved from some kind of early iterations where the basil, you know, the two, you know, they still operate uh semi independently. But they connect the information with these threshold and predictive low glucose suspend. So the first ones that there and we still have some of these on the market as well. So like if if an individual's blood sugar hit a certain low, um the pump was shut off for two hours and then resume. So it kind of helps when when your blood sugar got to a certain point. The second iteration of that was a predictive low glucose suspend. Um and both with tandem animatronic do have these available right now. So If the rate of change is so fast that it's predicted that they're going to hit an urgent low within 30 minutes. That pump part is already shutting off, but it's just this on and off on and off feature versus where we are now, which is a hybrid closed loop. So we have these algorithms now that connect the pump in the sensor to automatically adjust that background insulin. Give some little little bullets is to try to bring down blood triggers If blood triggers are on the rise, decreases the basal rates if blood sugars are um too low. But the user does still have to dose for the bullets is for the meals and that's where we're at right now. The hybrid closed loop. The fully automatic automated insulin adjustment for the full closed loop is it's coming soon. So that's where we're headed. So just to kind of visualize all those pieces, the hybrid closed loop. You gotta pump CGM proprietary control algorithm. And all the user has to do is is bolus. Um, the current FDA approved hybrid closed loop systems are available from Medtronic and tandem omnipotent system should be coming out in the next couple of months and so you can see the each of them have a different control algorithm. They use a different sensor and then it's linked together with their specific pump. Um and then just a quick word on um do it yourself system. So because this technology has been slow to getting that artificial pancreas system released, a growing community originally based in the Bay Area, identified with the hashtag we're not waiting over the last decade has developed an open source code for a do it yourself loop system. The two platforms are loop and open A PS. And effectively the user builds the system takes an old pump or links to omni pod through a separate rig or a link to another device. But that allows the two devices then to interface with the computer, the program that they've built through the cloud. Um and you have to keep that rig really really close to the body. Um they're not FDA approved. Although the tide pool group in Palo Alto is in the process of doing a formal build of loop and submitting it to the FDA. So, you know, and those variably endorsed do it yourself loop families. No, it's not FDA approved providers are very vocal about reminding them that it's not FDA approved until they do take on the responsibility of knowing that it's it's at their own risk. So next couple slides show some of these systems in action here. Um We've got a sensor integrated pump system. So you've got CGM and pump but they're not connected. The top tracing shows the C. G. M. From midnight to midnight. Green levels are in target range. Purple is above, red is below and the middle area shows the bolus is the carbs are in the yellow bubble rectangle is the amount of insulin being delivered like on demand. Um And the bottom are the programmed basil rates. You can see certain times it's up, it's down um For this individual really all they did was Bullis for a lunch and a snack carbs only no blood triggers and the rest of the day actually remain, you know, fairly even but above above target. So it kind of shows you basal rates probably pretty good, keeps you pretty stable. They had dosed more. Probably gave a couple of bullets is for blood sugars would have brought it down into range. And basil rate, you know, would have kept them in target. But um you can see kind of with the separate pieces, you know, it would be nice if if there was some Autumn ization there. Um this is a predictive low glucose suspend system. So you can see at the bottom, You know, the basil rates are shutting on and off frequently overnight, kept the glucose tracings beautiful. Um, in that 70 to 80 range. Um and in the day glucose rises maybe from under dosing carbs in the morning. Um and the tracing, it's fairly stable but above target and that, you know, predictive low glucose suspend system is really great with lows but still up to the user to control the highs. Here is the hybrid closed loop, the user, you know, bullets regularly in the day for carbs. Um and below you can see that dynamic variability of the basil rates. Um plus these kind of little tiny bullets is um, you know, in the day um to these little micro bullets is you know, to kind of keep them in range. Um this individual dropped a little low after dinner for like a microsecond that the pump shut off because came up And on this day. Amazingly then this patient spent over 90% of time and range. Here's a user who did nothing for two days. So they let the hybrid closed loop system do its thing. You can see clearly when they ate glucose levels went up large glucose excursions, but I mean, I didn't hit 600 stay high, you know, for 24 hours that control algorithm ramped up the basil raid. Give all these micro bullets is all throughout the day and brought them down after a couple of hours. So even with Noble is saying this was really really amazing couple switching gears here. So a couple of other things in the technology world. There's a lot of different apps and software software from the manufacturers to display data. Look at data and patterns. Lots of different apps that are out there just highlighting some of these um calorie king for carb counting my sugar for um patients to kind of track their insulin injections and then tide pool and Glucophage really like big picture data visualization tools that we use a lot of these in our clinic and a lot for patients as well. Um So how does how does all this you know add up. Um Early studies were kind of mixed on the benefits of C. G. M. And pump um and severe hypoglycemia. Um This as we're moving forward you know the literature has been more consistent in supporting positive health outcomes related to glucose control and severe events at all ages. Um so the sweet study over 25,000 patients with type one monitored um in the in the late 2000s um and uh showed a one C. D. K. Events of your hypoglycemia events were lower with technology use um And here you can kind of see the data from this is the a one C. Data. Someone on the left hand side of injections only no sensor and then progressively adding technology that will pump and sensor. Um there was An improvement in a one C by close to 1%. Each device added about half of a percentage decrease in the A. One C. So I mean not huge but I mean in in the A. One C world that's pretty that's pretty good. Um Here's some recent data on closed loop. I'm just going to kind of cut to the chase here that um a lot of hybrid closed loop studies are showing improved time and range um by a large amount more meeting consensus goals on A one C targets. Um uh and and hippo severe hippo events really cut down by a large amount. So um kind of last last few thoughts on here, you know challenges and burdens of technology. You can see you know they've got had a huge positive impact and quality of life but it doesn't come without its challenges. You know, navigating a new devices on the market can be intimidating lots of education, learning new things upgrading. Trying to understand and decode the patterns from day to day by day can be overwhelming um alerts, alerts, fatigue, there's alerts for everything especially for teens. I mean they're just getting alerts all over the place. They just ignore them or turn them off device anxiety for young kids. Um Major issues. So I mean each set or sensor change can lead to a huge stress on kids and their parents can be frequent school and sports disruptions and then, you know, finally with our adolescents, you know, respect of independence and privacy can be hard, especially with these real time share features. Um so a lot to lot to impact from, from the technologies here. Um you know, the psychosocial stressors of diabetes, particularly in youth is huge. Um diabetes burnout or diabetes fatigue described as a state of feeling run down, emotionally drained, completely overwhelmed where someone with diabetes grows tired of managing their condition and then simply ignores it. Um we've talked through some of the contributing features, you know, burden of care. You don't can't turn diabetes off. There's there's you always have to be thinking about it every little impact in your life. Does something to glucose levels and whether or not you intervene on it, you know, it's kind of part of the day to day decision making, process their data overload and then language is important. You know, when you're with your patients and you can encourage parents as well, you know, try to avoid phrases like good or bad. Glucose is right or wrong, poorly controlled, noncompliant diabetic, you know, a person doesn't like to be associated by defining by being defined by their disease. So use terms like above or below target, meeting goals more or less frequent dozing a person with diabetes. Um our our patients are really at an increased risk for mental health issues, stress, anxiety, depression, body dysmorphia disordered eating. The ADA recommends starting depression screens and all persons with diabetes between ages 10 and 12. Um So some of the strategies for problem solving, you know, it involves a lot of motivational interviewing. You know, what's the hardest thing about diabetes for you? Right now? We help patients re set their expectations. Break things down into small steps. Small goals, encourage them to take a break, keep up self care and then communicate with others. You know how, how they can help them and to also connect with the diabetes community. So, you know, to wrap up lots going on in pediatric diabetes. Focus today was really on device technologies with next steps being that full closed loop, which is complete auto delivery user doesn't have to do policies anymore. Everything will just be automatic. A bionic pancreas, insulin and glucose gone together in a system. And then areas of research really exciting are immune modulation and islet transplant, you know, still not quite there. Um but really getting closer. Um So the take home points kind of looping back to the beginning. Pediatric diabetes management is not just the treatment of little adults. We've got different needs and challenges across ages and stages. Um Type two is really a different entity. More aggressive path. The path of physiology is different. Um You have different tools and meds, especially for type two and then with with all forms you've got huge psychosocial stressors especially as patients are navigating a lot of the different transitions um in childhood and independence, diabetes, fatigue and data overload are huge. Um With the device technologies that are available, pump and CGM are associated with decreased A one c decreased hypoglycemia and improved glucose time and range um and improve quality of life. These devices should be available to all pediatric patients with diabetes. Um and then everyone specialty providers and and primary, you know, everyone needs to know how they can how they can help because every individual diabetes need support even as they get older, so knowing how to screen, recognize how to direct and refer become important. Um these will be available you know after after the talk, but just a lot of good resources for directing patients on how to connect with the diabetes community. Um and then there's a couple of links here to the two major consensus guidelines on management from American diabetes association on top and then the and spot the International Society of pediatric and adolescent diabetes. So latest guidelines are out there. Um you know, having a partnership primary care with the endo is huge. You know, um we always encourage You two talk about having, you know, the patients having a regular dialogue with the endocrine team, making trigger, keeping up with every three months visits um making sure they're getting a one c checks every three months, especially with telehealth visits. You know, we would do it in person in the clinic but with a lot of telehealth going on. Sometimes either one of us has to order an A. One C. To be done so we can keep tabs on what's going on. Um You being attentive to language, support and empathy to the burden of diabetes knowing what these technologies are so patients can feel comfortable talking about you know what they said is and and you know having a skin infection and what it all means kind of have all the parts to put together. It's really really bonding um Peace with them and how to direct resources using inappropriate language. Um And again keeping them on task with their screens and vaccinations really really important. Um So here's our UCSF pediatric diabetes team um clues everybody cross bay. A few of us providers go both sides. We do have satellite clinics and santa rosa and marin. I go to Salinas we have a partnership with S. V. M. C. Um And so we see diabetes diabetes patients down there. Um We do have a pre diabetes clinic as well A Type two Specific Diabetes Clinic. And then this last point here on diabetes referrals you know who who who should come to us everyone everyone with diabetes prediabetes abnormal glucose evolving diabetes um New on sets are really urgent. Not not appropriate for a paper referral. Um Really good to page the on call and just kind of triage whether an outpatient referrals appropriate. Could we do in some cases in clinic nuance that teaching over several days as appropriate. But if you're able to at least to kind of help understand how urgent um the needs are you know getting a point of care glucose or urine dip in the clinic is helpful. They're symptomatic and have really high blood glucose is obviously you send them to the E. D. And if you are unable to get hold of pedes endo and you really don't know what to do. But they're symptomatic. I mean they should go to the E. D. And never be faulted for that. Um specific to UCSF for any transfer of care. Not not urgent pleas market as diabetes or diabetes clinic because we do have separate triage processes for general endocrine different physical teams and locations on the west by side and then prepping a family that that first visit is going to be long. You know several hours introduced to the full team. Um So just a lot of pieces to kind of put together. Mm hmm.
