This is part 6 of Project ECHO: Prevention and Management of Diabetes and Cardiometabolic Disorders in Community Health Centers. This series explores diabetes and cardiometabolic care from the endocrine perspective and the factors unique to the health center community, such as the need for clinical care integration and mindfulness towards health disparities. This 6-ECHO series will focus on approaches to cardiometabolic care and management in the primary care, and typically rural, setting and how to bring best practices to this unique arena. The ECHOs will incorporate endocrinologists and FQHC staff, such as certified diabetes educators, nurses, and behavioral health specialists, as they explore the many ways to manage diabetes and its comorbidities (such as depression, cardiovascular disease, hypertension, etc.) as well as considerations when working with the special populations FQHCs serve. This series will bridge the gap between specialty endocrine care and the primary care setting by focusing on FQHCs and their unique placement within these special populations.
This presentation describes the regulatory landscape for diabetes technology and current AID systems, and also compares open-source and commercial AID.
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Rayhan A. Lal, MD: [00:01] Alright guys, we're getting started with our last session here. Welcome to the November 16th meeting of the Endocrine Society ECHO here. Let's do a quick round of introductions for those on the line and I know people will be trickling in... Maybe start with the hub team.
Liz A. Beverly, PhD: [00:33] I'll start. My name is Liz Beverly. I'm at Ohio University, which is in very rural Athens, Ohio, and I focus on behavioral diabetes work. I'll pass it to Nick.
Nicolas Cuttriss, MD, MPH, FAAP: [00:46] Hey, Nick Cuttriss, ECHO Diabetes Action Networks, pediatric endocrinologist.
Shirley Wong, PharmD: [00:54] Chris?
Christopher West, PhD: [01:04] Sorry, just getting my call set up!
Lal: [01:06] No problem. No problem.
West: [01:07] I'm a practitioner at Open Door Community Health Center.
Lal: [01:11] All right, guys, and then our first folks. Cyd, do you want to start us off?
Cyd Bernstein, LCSW: [01:27] Yeah, sorry, I wasn't sure if we were introducing ourselves or just waiting. Cyd Bernstein, I work at Anderson Valley Health Center. I work with people with diabetes doing health coaching and case management.
Lal: [01:41] Thanks. Do you want to throw it to someone else?
Bernstein: [01:44] Leah
Leah Collins: [01:47] Hi, I'm Leah and I work with the Anderson Valley Health Center. And we are really proud of our diabetes platform that we've built there.
Colleen Hough, RDN: [02:01] I'm Colleen Hough, I'm a registered dietician/nutritionist and I work for Open Door just south of where Chris is.
Wong: [02:10] Hi, everyone. I'm Shirley Wong. I'm one of the pharmacy residents in Solono County with University California.
Lal: [02:18] Awesome. Thanks, everyone for joining. All right, Andrea, I can start her presentation here because I know it's we have a lot of slides to get through. Give me one second here. Today we are going to do a tech deep-dive and the 20 minutes we have. Here are my disclosures: I do consults for a lot of diabetes technology companies. Just in terms of myself, here I am Rayhan, I've had diabetes for 35 years. Growing up, never wanted to do anything diabetes related. I wanted to be an engineer because I was a huge nerd. So I did electrical engineering and computer science, and while I was working in industry, my two younger sisters also got Type 1. When that happened, I decided to shift gears, become a doctor so I could help my brothers and sisters out there with diabetes. Couldn't decide whether wanted to take care of kids or adults with diabetes, so I did med peds over at LA County Hospital, one of the very underserved communities in the US and then ended up at Stanford to do a combined adult and pediatric endocrine fellowship. Right now I'm a physician scientist, I spend about 75% of my time doing diabetes technology work, and the rest of my time doing clinical, largely focused on the 16 to 26 year group that we tend to lose as we move them from pediatrics to adult.
A quick introduction to diabetes technology. Some of you have seen the submarine-backpack-looking device, and lots of people are told, "Oh ha ha, look at that huge thing! Look how far we've come. Now the insulin pump fits on our waist," but actually, this is an insulin and glucagon bio hormonal intravenous automated insulin dosing system made in 1964, and if we're really lucky, we'll get a subcutaneous biohormonal trial 59 years later in 2023. So, old ideas that are being made more available as a result of technology changes.
In terms of automated insulin dosing, we've seen rapid changes in diabetes technology over the last couple of years. Why is it that in the European Union they have six approved AID systems and in the US, we have three? Because our FDA had this brilliant idea that they would make interoperability designations. Sounds like a good idea in theory, but of course, money comes into play, and then that hampers creativity. There are Class I medical devices that just have to meet certain general controls: they have to be clean, for example. Class II medical devices have to satisfy some general controls plus special controls. Those special controls are not defined by the federal government or scientists. They're defined by the first device that is approved in that class. Why is this interoperability designation disastrous? Because this is the fastest way through the regulatory system, and the first device to become an integrated CGM—some might think of this as an interoperable CGM—then sets the precedent under which all subsequent devices are approved, and if I'm a company who knows exactly what makes me get through the regulatory process, what am I going to do to block competition? I will patent every single thing on that list that allowed me to get approval, and then only companies bigger than me with bigger lawyers can then get a CGM approved. And that's disastrous for actually creating a competitive market space.
Same story with Ace Pumps, alternate controller enabled, and notice it's enabled but not required. And then integrated automated glycemic controllers, there is no precedent for someone writing an algorithm to help manage the data between the CGM and the pump without already being partners with a CGM company and a pump company. As a result, it becomes nearly impossible for a controller company or someone who just writes software to get into the game without also having deep pockets. But we do have three players and they do have a system that basically closes the loop between all these three pieces here. And as a result in the US, we do have three major manufacturers of these devices, but it's getting harder and harder to gain entry if you are a startup or someone who has less money than these guys.
So every US pump manufacturer now has an AID system, there is no question in systematic meta analysis, network meta analysis, AID improves time and range, it improves A1C, and reduces severe hypoglycemia. There is no more question about that. And doing further studies on this at $1.5 million a piece probably doesn't add much to our knowledge base. For most people with type one diabetes, the benefits of AID outweigh the risks. So here's the current, state-of-the art right now: on the left we have the open-source systems, open APS loop, Android APS, Free APSX, commercial systems, Medtronic770G—we're still waiting on approval in the US for the 780—Tandem Control IQ, and Insulet Omnipod 5, which received approval earlier this year, but still does not have smartphone integration. In terms of CGMs, we do have approval for the Libre3, we have those now in the US. They're small. They're about the size of a penny. Dexcom G7—which is approved in the EU and is being distributed there—is about the size of a nickel. Why is designing any of these systems challenging? Because insulin is slow and even our fastest insulins still have a tail going out to as far as six or seven hours. So if you're designing a self-driving car where it takes an hour to reach peak acceleration and six hours to decelerate completely, that's a tough challenge for any engineer.
Let's talk about algorithms in general here: PID controllers are basically just dependent upon glucose, you have an incoming CGM glucose, which is subtracted from a target glucose, and that subtraction results in a function over time. We can do many things to functions over time: we can take their value at a given point in time and multiply it by something that we call the proportional term. We can take the area under the curve of that function that we call the integral term. And we can take the derivative, the rate of change of that function, and take each of those pieces, scale them by a factor, and add them together, and that comes up with an insulin change. This sort of controller is not settings-dependent. It's just glucose-dependent. In terms of other control strategies, we have fuzzy logic, where basically we take a priori knowledge either provided by experts, or maybe machine learning, and we say, "Under this, that, and the other condition, this is what we're going to do to insulin delivery." It's basically logic, but we abstract the current state. So for example, instead of saying, "Add a blood sugar of 82," we do this: We divvy it up into low normal high, very high or very, very high. We abstract it, that's where the fuzzy comes from. Predictive controllers, which are the most popular these days, try to come up with what is the future predicted glucose. They add up what is the effect of insulin and lowering the blood sugar? What is the effect of carbs on increasing the blood sugar? Add in some other adaptations, and then try to predict where the future glucose is going and affect insulin delivery to make that future glucose push into the target zone. And this is an example with loop on the left here.
Let's talk about CGM, because we can't have any of this without CGM. First of all, we talk about the accuracy of devices, oftentimes using this Clarke Error Grid, which is coming from the late 1980s. At the time, they were considering fingerstick meters as the test case, but now we do this with CGMs. Basically, they look at where is a mystery going to be dangerous. They say if you're within 20%, most of the time, that's going to be a good situation, that's the A zone. B is greater than 20% error, but you still probably won't cause harm if you're in this space. C will lead to potentially unnecessary harmful behaviors. For example, if your reference glucose was at 100, but you read it as 400, you might have a problem there. In zone D, lows and highs are undetected—obviously, that can be bad. And region E is sort of the worst case scenario, you're reading less than 40, when you're actually greater than 400, or vice versa. This is how we sort of judge the performance of sensors.
Now, one thing to note is that CGMs do not measure blood sugar, they measure interstitial glucose. What is the difference? This was an animal experiment where they infused glucose into a pig, and they measured with CGMs in the arteries, veins, peritoneal cavity and interstitial space. You'll notice that when you infuse the glucose, you see a spike and then a flattening that occurs once you give it IV. The red and blue lines are probably closest to what's really happening. The blue line in the intraperitoneal space, you will notice that you still see a spike and it still settles out. But the spike has been attenuated. With the interstitial signal, the spike has been completely eliminated. We don't even know when the infusion necessarily took place because there's a delay there. And it's time delayed, so the problem is the regulators mandate that you have to compare to a gold standard, and what is their gold standard? It's a venous glucose drawn from a vein, and compared to an interstitial glucose. All the work that these companies do on the signal processing side is to make this gray line look like the red line. They employ lots of signal processing to try to make this signal look like the venous signal. Why does that get challenging? Because you might coerce it in the wrong direction. For the majority of the population it works well, but that signal processing can lead to issues for single individuals.
Also important to know about CGM: If you turn off the signal, there is no accuracy penalty for the company. Imagine you're this person Same with a blood sugar that seemingly is starting to drop, but the system doesn't know whether you're actually dropping or whether the wire has come out of the skin. What does it do? They decide to mitigate the problem with "We don't know what's happening, we'll just turn off the signal." They don't incur an accuracy penalty, they get higher marks with the agency, but you can see if you are the person using this, it can be a scary situation. Let's just talk briefly about the options here. Dexcom G6 for right now in the US—10-day sensor, replaceable transmitter every 90 days, and the sensor gets changed out every 10 days. The Guardian Sensor 3 is a six-day sensor made by Medtronic. You do require calibrations with this one, where you don't want the Dexcom. The Eversense is now approved for 180 days. This an implantable sensor but unfortunately still requires calibrations, and this is a noisy, not-smooth signal, but with low latency. Then the Libres 2 and 3, both 14-day sensors. The Libre 3 has slightly better accuracy per the company's reporting, and no calibration is required on this one.
Let's talk about commercial AID, the Medtronic 670G was the first commercially approved system. It uses PID with an internal model of insulin on board. Unfortunately, there were significant usability issues—we published this in diabetes care—that by 12 months, about 46% of people didn't use auto mode at all with this system. This all stems from a lot of these usability concerns. At the time, the agency was saying, "We don't trust sensors for nonadjunctive insulin dosing, but we know there's a terrific demand for automated insulin dosing." Medtronic's mitigation was when something is not going as expected, turn off the system and tell the user to check with a glucometer. Also, the screen is upside down for the user. For taking pictures that looks very nice.
The 780 G is newer, they use better-tuned PID, also internal model with insulin on board. But they've licensed some fuzzy logic from Dream Med, with questionable mixed messages from Medtronic on how exactly all of this stuff is put together and used for the system. One of the nice things Medtronic is coming out with, they just started their release of the seven-day extended-wear infusion sets in the US, and they're thinking that in the future, they will run one of their sensors through this extended-wear infusion set seven days times or seven day infusion set. So then you have a one port device. It's been tested in Israel, it's going to be coming over here for testing in this somewhat near future.
Tandem Control IQ received approval in December 2019. They use a state estimator using a Kalman filter to guess about the glucose and insulin in the body using available data and comparing it to an internal model. The Omnipod 5 had its released early this year, but there are hurdles to using it with a smartphone, and now we're getting recall notices that the batteries are swelling in some of these devices, the charging cable on the on the Omnipod 5 is getting very hot or catching fire. Wouldn't it be nice if they had just gone straight to the smartphone? The algorithm aggressiveness changes abruptly after the first pod, so users need to know that that first part isn't going to be pushing as hard as the next one. Well, we also don't know much about the inferred setting: What happens if we initialize basil settings way off from what they should be? Again, about smartphones, we really want to use things people already have.
Open source AID on the other hand, these systems have existed before the commercial systems. There's no industry, no regulators to worry about, so when the people living with diabetes develop the device, we don't have to worry about the regulators, we don't have to worry about the companies, there are no mandatory alarms. There's a focus on safety. There's a beautiful interface, you can use your own smartphone, and it's available in dark mode and you can actually know how the algorithm works. Miraculous! We have retrospective, prospective, and randomized control trials showing that the open-source AID systems are effective. This was a prospective observational study of almost 1000 people, this was survey data on several hundred people. This was a the Create Trial, which was a randomized controlled trial out of New Zealand, with 97 participants. And then myself, Katerina Brown, and Sophia Hussein put together an international consensus supporting the use of open-source systems from 25 different countries. Living with chronic endocrine disease has challenges that can potentially be overcome with the help of technology. None of these technologies are perfect, and until you get to perfect, you have to know how something works. We have to—as physicians, as companies, as regulators—we have to think how our mitigations, these changes that are thrown in at the very last instance, how they adversely affect the end user in commercial systems. Open source systems offer sort of unparalleled transparency and personalization when it comes to all of the options available. With that, I will thank the endocrine teens at Stanford, my mentor, Dr Bruce Buckingham, the NIH and JDRF for paying my salary. Here are some references for the talk. Thanks to everyone. Let me just stop for a second—if there are questions, and I'm sorry, that was a whirlwind tour.
Bernstein: [21:47] Rayhan, when you were mentioning the decline in users using the quizzes system on the Medtronic, if I got that right. Is there reasons cited for that?
Lal: [22:00] The main reason we're sensor issues in the paper. Basically, the main problem is, at the time, the regulators didn't trust the sensor, so it's far easier to just say, "Turn the automation off, when we don't know if the sensor is right or not," than it is to say, "Power through and continue giving the person insulin." The 780G—which has been approved in the EU, and it's been out there—in addition to the extended-wear infusion set, people have had much better acceptability. They're not having to calibrate as much, they're not being thrown out. Really, what's keeping people on the 670 and 770 right now is honestly just brand loyalty at this point. It is unfortunately a clunky system to use these days, but we get by with what we have access to, and some people will put up with the calibrations. I think tandem smart decision was to couple with the company, one who lives right next door to them, but also to couple with a company that doesn't have calibrations. So that's part of the beauty of that system.
Bernstein: [23:32] It seems like trust is kind of an issue at every level. You're talking about it with much more detail, but with regulators, there's an issue of trusting the devices, the company is trusting the users, and, from my experience, it's also providers trusting both themselves and their understanding, and then also patients. I'm just curious, there are so many barriers to getting someone on an automated delivery system, even though yes, we know that they are ultimately the best. When I see this from a rural health perspective, I don't see that many people willing to step forward and say, "Yes, we know this is the best technology and we're really going to go for it." I'm just curious: How do we do this?
Lal: [24:20] This is, and this is one of the unfortunate thing about all of diabetes technology from research to dissemination. It's the 1% who benefit from everything, right? It's the 1% who are the participants in the trials, white, college-educated, making more than several hundred K per year, those are the people who participate in our trials. That same population is the ones who have access to insurance, who get the tools first off the line, and also they're the ones who carry the least burden of diabetes management. It's an ass-backwards problem we have here. Everything that we want to do to help the population at large is set up against us in diabetes technology. It is our job to create an army to get this into the hands of the people who need it. The same thing goes from the pharmaceutical industry, right? Why are the Kardashians getting GLP-1s? But my Type 2, who is on insulin, is not? It's mind blowing that that such issues can exist.
West: [25:41] I had a question... about it really goes along with this issue of access to things. I have a number of patients who get started, they get their Dexcom and whatever insulin pump, and then suddenly, they're waiting for insurance to get them their supplies through a third party distributor. I'm wondering if there's any policy changes or anything you see on the horizon to help around that process?
Lal: [26:02] Well, the way we have tackled this in the past is: you try to do a study, and you try to do it on a clinic population rather than your first comers, your professional research participants. You say, "Okay, now that this technology is available, let's just try it on everybody in our clinic, let's make this a parsimonious, no-consent process. Let's just try to get it on people. And you get it funded for a period of time, and unfortunately, for a lot of public payers, they not only need to see that it actually benefits the individual, but that taking it away then hurts the individual afterwards. To get Medi-Cal CCS to cover CGMs for our underserved pediatric patients, there have had to be papers written that not only did it benefit them when you gave it to them, but it hurt them when you took it away. This is deplorable ass-backwards type of situation, but it is not solely the fault of the payer. It is also the fault of the company who decides to charge ridiculous quantities of money for these things. Do you guys know how much... you can build an insulin pump for about $97 with a Bluetooth commanded motor if you wanted to. Most of the Durable Medical Equipment sells for several thousand dollars. The CGMs that they sell, you know they stand up very proudly and say "We have decided it's going to be $10 a day for all time." Guess what? It costs them $1 to manufacture. Same with insulin right? Why is it the rest of the world can get a vial for $25 bucks and we pay $350? It's because in the US, profit-based motives take over everything. You have our politicians influenced by the money as well, and it just becomes this whole fiasco of "How can we make the most money in the American health care system?"
Cuttriss: [28:33] This is Nick, going back to a question you posed, Cyd. I think in terms of starting patients on AID or making the decision. Whether you're prescribing insulin, multi daily injections, there's risk for hypoglycemia and risk for hyperglycemia. I also think the same thing is true for automated insulin delivery and pumps. I think there's a risk all around. I think it's all a matter of if patients want this and think it's going to be easier, who are we as people to say, "No, you can't have this because there's too, much risk." We're empowering our patients to make decisions every time they pick up their insulin that can you know, kill them or not do enough. There's the insurance but then there's also "How long does someone have to have diabetes for before we can have them not suffer as much and prescribe them this or, is there a rule, an A1C? I pose people to kind of think differently about that. In terms of on-label off-label, insulin is insulin, and delivery is delivery. There's lots of people who don't feel comfortable giving insulin even with injections, and we come up with carb ratios that are probably arbitrary as well.
Collins: [30:07] I think I think kind of what Cyd is also saying is that, unfortunately, because of our situation, a lot of the hand holding and the education really falls on us. Obviously, we are very connected to the providers and the physicians, but we do a lot of hand-holding. I feel comfortable now moving in the circle of, you know, "mealtime" and "long-acting" and all that, but that step to the to the pump is intimidating. I don't have a lot of confidence in the endocrinology referrals that we have done nearby. I have just been very non-impressed with the local endocrinologist that we have access to. I think it's also us. We feel nervous because even though we know we want to try it, we feel nervous about taking the jump, I guess.
Lal: [31:01] I think the other the other thing to keep in mind—and we'll move on to the case in just a minute here, but this a great discussion—is that there is a profound difference between thinking you understand the system and actually understanding it. I think having a rep come to an endocrinologist clinic makes them feel like, because I have this person coming and talking to me about all the virtues of this system, that I have a really good idea about how it performs and the algorithm and all this business, when the rep themselves does not know how the algorithm works. Yet, people complain: "Oh, we don't know how open source systems work!" When in fact, open source systems, you can open it up, read the code—or have somebody who knows how to read code read the code and translate for you—and actually understand them. Yet they feel that's an even harder lift than then the commercial systems where you only have a sense that you feel comfortable with it.
All of this business of provider comfort, I don't feel necessarily 100% comfortable—even though I probably have more knowledge on these algorithms than most people do—I would say I don't know exactly what constants the company chooses, what they've hard coded, what things they decided. But we have to, at some point, say: "They are a company, they're going to hide behind this intellectual property label, and so I just have to take it on face value that this is going to help the majority of people and use it." The other question from Liz is: Are there any behavioral issues that influence whether you start individuals on diabetes technology? I take the tactic of always offer. I think as long as you provide an opportunity, the person can say no, but I don't ever want to say, "Because of a bias I have I did not offer a person something that could have improved their well-being." It is sometimes a very difficult sell. Even as somebody who wears this device, I can tap my eyes and show them that, "Hey, your doctor is using these devices!" That doesn't always go as far as we as we need it to. Jay says "Pump body programs can be very helpful." Community support is really an awesome thing for getting people to decide on diabetes technology. I cann't tell you the meaning to the black community, when Tandem started putting up people with diabetes—who were black—using their devices that was so meaningful, because every picture before that had been some white person jogging on a beach somewhere. If you do not see representation, you will never buy into any of this. Chris says "I think frequent check ins for the first few weeks helps greatly." Absolutely with anything, when you make an intervention, you want the person to see the efficacy. You want them to have your support so that they feel like they're getting some benefit out of this. This is why Jay always recommends rapid up titration of insulin so the person doesn't feel like, "There's there's no effect from this. This insulin isn't working for me." But guys, I don't want to cut Shirley's time too short here, so maybe we can jump to her case.
Wong: [35:01] No this great discussion, so no worries.
Lal: [35:04] Thanks, Shirley.
Wong: [35:20] This patient is a patient of mine since August. I believe Dr Shubrook was the one who referred in TerraPharm home program. A little bit background: Our program is run by pharmacists, and we help the patients in between the provider visits. They'll still see their primary care and their diabetes specialist every three months or every six months, depending on the necessity, and then we help them navigate some of the challenges in between whether it's with insurance, pharmacy refills, etc. She's a 59 year old, Black-Hispanic female, she has Type 2 diabetes, and she was diagnosed since 2020. Other conditions that she's currently still managing is SVT. That was a long time ago, about 11 to 12 years. At the time that she was diagnosed, she also had elevated blood pressure, so she was diagnosed with hypertension. She's still currently dealing with some of the pain from her spinal stenosis in the lumbar area, and vitamin D insufficiency. She has no history of recreational drug-use, smoking, or drinking.
At the time, I think this was per the last discussion, we had talked about the PAID on problem areas in diabetes, she scored a 14. She was—at the time when we saw her was a year after diagnosis, so it was very overwhelming with her. She was trying different medications, she was on insulin. Fast forward a year later, we just conducted the pain score again last week, so it was perfect timing. Her score was five so went down from 14 to five. She feels a lot better. She's said she lost weight and also mentally she's like feeling better about all the diabetes management, she feels like she has better control compared to like a year ago when we saw her. Her these are some of her lab values. This is from I believe August, that was the most recent last draw. So mean glucose was 136, or A1C was 6.0, and compared to a year ago, it was decreased from 12.6%. And then you can see the trending down 7.3 in February and then May was 5.9. Her weight in May was 188 pounds. And then in August, she lost about eight pounds, and her blood pressure—she's on just one blood pressure medication, Metoprolol tartrate, 25 milligram, twice a day—it was meant to regulate her heart rate because her heart rate is still quite elevated, even on a beta blocker. But her blood pressure has been within target most of the time.
We were able to get her a free blood pressure monitor through her insurance. They delivered it to her back in March, so she started checking every day. She is on a turbo stand 10 milligrams once a day. She was previously on Lantus, I think it was 30 to 30-something units in the beginning when we saw her, so we continue to titrate down when we initiated the GLP-1, and now she's stable for at least couple of months on the one milligram weekly. Some of the things that were concerning was a couple months after she started calling us saying that, "My sugars are low, in the 70s and 80s." And she was sweating and feeling really weak, so that was one of the concerns. She didn't want to start back on insulin or consider other therapy just because it's a once a week injection and she didn't want to be on anything on a daily basis, and she was happy that she's like on less medications.
Previously, she did try Prenulin insulin, metformin and basal insulin, and I think that was mainly it. Oh, and some of the social concerns: she did have difficulty last year with Medi-Cal coverage, and also with the county insurance, so she was worried about supplies not getting covered. But as of right now, it sounds like it's okay. She hasn't had any recent issues. Social support, we never really discuss—sounds like she's always on, around and about whenever we have appointments. We usually do phone appointments, and she's out working, or she'll take a moment or 30 minutes of her time at work, so we never really further discuss her social support, but I can tell from her demeanor when she's talking, she's more upbeat. So I don't think she's feeling any depression or anything. And whenever she needs something, she always reaches out and she'll let us know.
Lal: [39:39] Shirley, what an amazing job that you guys have done here. I'll throw it over to the spokes for any clarifying questions.
Collins: [39:52] Did you say when she was having the lows that was just on the GLP-1 and not on insulin?
Wong: [39:58] Correct. And that was that the one milligram, we had titrated her from point five to one, and it's been almost four months in. And then she called us saying that she was feeling low, and then what she ended up doing, was eating a Snickers bar because that's what someone gave her when she was outside.
Bernstein: [40:17] Do you have a sense of what her diet's like and if she eats regular meals?
Wong: [40:23] I think her breakfast is what she typically skips—she's not a big breakfast person, she says sometimes if she eats, it's probably coffee and then a light snack, and then she'll go through her day go to work, and then that's when she'll actually eat a meal. I can double check the exact foods. I don't recall the exact food she eats. I just asked her recently, too. This is what she usually eats for like dinnertime: chicken, rice, sometimes she'll have fruits. And then lunch is [eggs?] potatoes. That was some of the examples she gave me. But she did notice that, because of the GLP-1, her appetite has been very suppressed. So she noticed you'll eat way less compared to before and I think breakfast, lunch, sometimes she'll skip. Not all the time. But lunch she'll eat sometimes. And the breakfast: usually coffee. That's been what her meals are like.
Bernstein: [41:23] I'm sorry, Shirley, on my screen, I can actually see your question. I just say given that the patient is experiencing occasional hypoglycemia, but mostly I'll manage and I didn't actually see that the question was.
Wong: [41:35] While manage on Ozempic, one milligram, weekly for many months, but, what's the approach in terms of addressing some of her low blood sugar symptoms? Because she's symptomatic, even at 70s and 80s? I don't know if there's a picture of her readings—she usually handwrites them—she always will check in the morning, she'll check at night. Based on the recent ones, she's been in the 70s and 80s.
Quiles-Sanchez: [41:58] Shirley, sorry to interrupt. Is that what you included on the next slide?
Wong: [42:02] I think so. [crosstalk] These are some of her recent ones that she sent me from October, and so it looks like it's gone back up—so it fluctuates. When I asked her, when she's in the 90s, she doesn't feel any different, 80s sometimes she'll feel it, so it's like on and off. The last couple times that she called me, she said, "Maybe it's because I just skipped my meals, and maybe I need to try to eat regular three meals." But I'm not sure if that's what will prevent her from having the lows because with GLP-1s, it's not one of the common items or a side effect.
Bernstein: [42:39] She's typically waking up very early naturally or does she have lows that wake her up?
Wong: [42:48] She wakes up early naturally.
Lal: [42:56] If there are no other questions from the spokes, I will turn it over to the hub team for questions.
West: [43:07] I'm curious what went into making the decision to kind of escalate her dose? Because it seems like she's been very well controlled, whether it was weight loss or other benefits?
Wong: [43:20] What made us decide to increase from point five to one?
West: [43:23] Correct.
Wong: [43:24] Okay. I believe I'm trying to double check when we increased her, I think was back in July, because she was ranging, postprandial-wise because we had her check after. I think at that time when we saw her glucose readings, it was above 150s or so. We had talked about weight loss, and so I'm guessing that was the main reason but I'm trying to figure out the exact date we increased it and compare to her glucose readings. While I look, if someone has...
Cuttriss: [44:06] This is Nick, while you're looking for that, just to clarify when in terms of stopping the insulin, around when did that happen?
Wong: [44:13] We were continually reducing around May. Early July, she was on five units of insulin with one milligram of Ozempic, and then at that day in July '15 was when we stopped it because she was ranging below hundreds for most of her readings, so we had just completed a trial of no insulin. At the time when she was still on point five on some of her fastening ranges were 150s, 130s and postprandials were around the same: occasional 200s.
Lal: [44:15] Shirley, can you describe what is the context of these loads? Because you're absolutely right: you can't get you can't get true hypoglycemia on one milligram of Ozempic, so what is the context? Is it that you're feeling that sensation, or she's waking up, or she just happens to check her blood sugar, and it's low?
Wong: [45:25] She wasn't checking actually. She was out and about, she was on her way to work that morning, and then she would call us and say, "Oh, my God, what do I do? Should I change my medications?" She was sweating. She was feeling physical symptoms—She was sweating, she was weak—and I asked her if she had anything available, and she said somebody was giving her a Snickers bar, because they walked by, they just happened to have it. There was another occasion, usually when she's out and about, I've asked her last week when I talked to her if she's had any recent incidents of it, at least in the last two weeks or so, and she says she hasn't felt that way. But she's been also regularly eating, so I don't know if that made a difference. So when I asked her like, what she thought may have caused her low, she thought, "Oh, is it because I skipped breakfast? Should I eat regularly instead?" At the time, I wasn't truly certain if like her eating three meals versus two meals would have made a difference, because she already has been skipping breakfast for a long time, that's like her regular routine. And she wasn't low previously when we had initiated and also when we were titrating from point five to one. It was a month and a half to two months after when she says she experienced the hypos. Does that answer your question?
Lal: [46:44] It does, it does. I guess a part of this is a little bit of reassurance, but we'll get to that when we're talking about recommendations where there are other questions from the hub team or the spokes.
Cuttriss: [46:59] This is Nick. Any recent cardiac evaluation or Zio patch for the SVT and looking to see how active that is?
Wong: [47:08] That I don't have and she hasn't seen her cardiologist, she only had her recent foot appointment and eye appointment. So SPT wise, I don't have an update on that.
West: [47:19] I kind of have a related question: If there's any signs of any fluid overload, any edema or anything like that?
Wong: [47:26] Will you say that one more time—fluid overload and or...
West: [47:29] Or adema.
Wong: [47:31] I never asked. I didn't ask her that question, so I'm not certain actually.
West: [47:35] And then the one other question I had for you is you mentioned she wants to kind of be on as minimal medications as possible. Does she have a preference at all oral medications versus once weekly injection? Or does it matter?
Wong: [47:48] No, she didn't prefer. I think my she had metformin, she had severe GI symptoms and that's why she was removed from that. She just wanted to be on minimal medications. Right now, her appetite suppression—she felt the difference. When we were titrating up, she felt the difference of her appetite, she wanted to eat less, and she didn't feel hungry at all. And oftentimes, um, she'll say that I just told myself to eat, because I know it should be eating dinner or should be eating lunch.
West: [48:14] I guess I'm curious then with that appetite suppression. Was it as significant on the lower dose of the Ozempic?
Wong: [48:28] Compared to now, you mean?
West: [48:29] Yeah, compared to now when she was on the point five?
Wong: [48:32] Oh, yeah, it's more now. But then I think since she's been on the 1 milligram, she's happy with it. I did ask her if it affects her quality of life at any point, then we can go back down to point five. But she said, "No, let's just keep trying for a little bit longer, and then if I really can't tolerate it..." but she says she's happy with it, and she's happy with the weight loss, so she didn't want to make a change. But I wasn't sure clinically, is it sound or appropriate to keep her on the one? Because her A1C is at six. To answer your question, Dr Shubrook, A1C, goal-wise, I would say less than seven for her is fine. She doesn't have significant other comorbidities that I would say we need to loosen the goal. And I think 6% is great. She did increase her exercise—I forgot to mention—she did increase her exercise activities when we started seeing since last year. So she's been walking and doing what she can to go out and about.
Beverly: [49:30] I have a general practical comment or question. You mentioned that for breakfast she's just having coffee. And I just want to pose: Have any of you ever just had too much coffee in the morning without eating? And you don't feel so good after that? I mean, it's possible. It could be something as simple as that. She's not eating as much and then she's exercising.
Wong: [49:53] That true that she's moving out and about. Maybe it's the coffee, caffeine—
Beverly: [49:58] And if she's not feeling as much now she's eating regular meals. I don't know that would be my...
Collins: [50:06] I was thinking about small meal—maybe instead of like maybe she's a big person who does two big meals—if she's able, I don't know what she does her day looks like, but smaller, healthy meals through the day. Even if it's just having, you know, nuts, carrots, some things that they she can have throughout the day, that maybe won't cause a dip. And then I think a CGM would be nice to just see the rest of the day since we're only seeing like morning fasting. But if I'm living in the low hundreds at baseline fasting, even without diabetes, I'm going to feel not right if I don't eat until you know 12. So to her point, it I agree that maybe some more sporadic meals throughout... small healthy meals as opposed to two big ones. And I'd be curious to see where those sugars are doing after meals in the afternoon.
Lal: [51:07] To that point, Shirley, the other thing people under appreciate about GLP-1 treatment, is you are in a significant fat burning state, and all of the shittiness you feel when you're losing weight, you're going to still feel when you're on a GLP-1, so you do need to just keep that in mind that some of the things people experience when on a GLP-1 are just concomitant with weight loss.
Wong: [51:37] Okay.
Lal: [51:39] And that might translate into that low feeling.
Wong: [51:45] Would it present—when you're weak and also sweaty at that point—similar?
Lal: [51:51] This is and this is the other problem, right? This kind of turns the glucometer—once you're out of the diabetes range ometer suddenly becomes a random number generator. It's like, "Oh, yes, I'm feeling this way and my blood sugar's 70, but is it because the blood sugar is 70?" It's hard to know, this is why they have that old eponym of Whipple's triad, right? You have to have a low by venous glucose, and it has to get better with administration of glucose, and you have to have the classic symptoms. And my guess is she does not fulfill all three of whipple's triad, particularly not the low venous glucose.
Cuttriss: [52:40] This is Nick, I'm a huge proponent of a CGM. But maybe in this case, it might be more like overtreatment and fear of seeing the numbers and being reactive.
Lal: [52:49] It will totally do that.
Cuttriss: [52:53] At this point, where things are so steady, you might even want to say "Consider not checking your blood sugar anymore, and taking a break, and maybe doing it more periodically every few months instead of every day now. If you're not going to change...
Wong: [53:13] ...her routine? If her routine stays the same?
Cuttriss: [53:17] Right. If you're not going to change the Ozempic dose, if you're going to keep things the same, maybe that reassurance...
Bernstein: [53:23] It seems like maybe it's a moment to look back on some patient education. Because she has been on insulin before, so maybe he's accustomed to being concerned about lows—and lows meaning something specific. I think maybe there could be a nice marriage, if you can have a conversation with her about: "On one hand, I absolutely believe you that you're having these symptoms, and it doesn't sound pleasant." And then also, "This is the way this medication works. This is how it's different from insulin. This is what it may be feeling like to start your morning with coffee or just be losing weight," so that she feels validated because it is really unpleasant, and I think sometimes really unnerving for people to not feel hungry. And at the same time, it seems like she's bringing the fear from when she was taking insulin into it too.
Hough: [54:21] I have a tendency to agree with what Leah was suggesting, because I have patients also who skip breakfast, I think it's the most skipped meal. But I say, "Can you have a little something? And can you have something with protein, something with carbohydrate?" And I go through examples of what that can be. And a lot of times they'll say, "You know—in addition to your coffee, you're not giving up the coffee—but just a little something and having those little somethings throughout the day can make a difference." I'm also curious: you said, Shirley, that she had started exercising and is that just increasing activity in general? Or is she making a specific time for exercise? And what time of day would that be?
Wong: [55:09] Time of day I'm not certain, but when she's exercising, her goal is to walk at least one to one and a half miles a day, and so she actively does that. She will make time for it around her work. Okay. Okay. But time of day, I'm not sure when she goes, I just know, sometimes she works in the morning, sometimes she's in the evening. So it depends.
Collins: [55:34] I would say if you're not going to decrease the Ozempic—or the GLP dose—is really trying to encourage the eating. We don't want someone who needs a Snickers bar from a stranger on the street. That's dangerous and scary. So I think if she won't come down, then she really needs to change those routines around food, even though it is hard and acknowledging that like Cyd was saying,
Wong: [55:57] Okay, I think the hard part is she feels the suppression, so naturally there's no hunger, but she just has to tell herself mentally, "I need to eat." I think that's one of the big challenge for her.
Hough: [56:10] I think I've had patients set an alarm on their phone to remind them to eat.
Wong: [56:15] Oh, that's a good idea. I will suggest that to her... I'll just answer like to confirm the what Nick was asking earlier: we stopped insulin back in May and then we started Ozempic, one milligram, in mid-June until now. So the one milligram started for three or four months now.
West: [56:35] One thing I was thinking about is: she's continued to make some positive behavioral changes, she's lost a lot of weight, she may not need as much medication. So maybe the lower dose of the Ozempic eventually would be helpful and might help her regain some more healthy eating patterns.
Wong: [56:36] Do you think in terms of... our goal is less than 7%. But for some patients, they tend to see like, "My it once he's like 5.9, or six," and then now that we kind of reduced the dose, how to address that fear, like, "Now it's going to go back up" or something of that sort.
Lal: [57:14] Shirley, I couldn't quite tell from the way the question was phrased: Does she want to get off Ozempic? Or she wants to stay on Ozempic and get just be off the other medications?
Wong: [57:27] Oh, she's okay. Staying with Ozempic, because that's the only medication she has for diabetes.
Lal: [57:33] Okay. I think the thing then to emphasize with her is just that this is not a medicine that causes low blood sugars. Just be very specific, that you can't get low blood sugar on these doses of Ozempic. But, as Cyd was saying, very important, validate that she is feeling something. I mean, there's no question there. It's just that she shouldn't associate that with hypoglycemia unnecessarily. It could be hunger, could be too much coffee in the morning, could be a number of things. And it's just important for her to realize those aren't always the same.
Wong: [58:14] Got it. I appreciate that. I'm trying to take notes.
Beverly: [58:21] I can summarize really quickly for you. I took notes if that's all right.
Wong: [58:26] Yes, thank you.
Beverly: [58:27] A little bit of background, again: It's a 59-year-old who was diagnosed with Type 2 approximately two years ago, there's been a decrease in the A1C. Right now, the last reading was 6%. And your major question was: she's been reporting symptoms of hypoglycemia when it's around a blood glucose reading of 70 to 80 and she's also had a notable decrease in distress. So your question is how to address the symptoms and what's going on there? Some of the really good suggestions are: I think it's an opportunity to reinforce some education, so validating with her that she is experiencing these concerns and these symptoms are not pleasant, and you believe her is important. At the same time saying what Rehan said that a GLP-1 is not something that will lead to hypoglycemia, but also acknowledging that she's having those symptoms, perhaps some of those reasons might be, she's doing additional exercise, she's not eating breakfast in the morning, she is consuming caffeine. Other great suggestions were having small meals throughout the day. Along with that, encouraging her to have just something small in the morning for breakfast and make sure that meal has protein in it, as well as a little bit of carbohydrate, and the idea of perhaps setting an alarm to remind her to have some of those small meals. I think those are all good, good points. Then there's brought up the point about doing the CGM because you don't have the readings, but it was also said that that might also be an additional stressor for her. So perhaps not changing it or not offering that at this time. In fact, you could also suggest that since you're not going to be making any changes for her in the foreseeable future, that maybe she can take a break from checking and monitoring her blood glucose levels. So I think that summarizes most of it.
Wong: [1:00:20] Can I ask a quick follow up? I think Chris had asked me about adema and fluid—I was wondering what that may be, why you were asking.
West: [1:00:30] I guess what I was thinking is another medication that could be helpful for her would be... an SGLT2. And so with the history of SVT, if she was having some symptoms of heart failure, then that might be a medication, that would be beneficial.
Wong: [1:00:45] Okay, got it. Thank you. And I will check on her heart. I don't have any update on her heart. So I will make sure to ask that for her next visit.
Lal: [1:00:54] Thanks to everyone for making this a great ECHO. Such a pleasure. Thank you to everyone on the hub team. Thank you to all the spokes.
Wong: [1:01:05] Thank you so much, everyone.
Quiles-Sanchez: [1:01:08] Yep, just to close out. Thank you so much, Rayhan, for today. That was an amazing presentation. And that was incredible discussion. Thank you, everyone for joining today's echo and a special thank you to Shirley for presenting your case. Everyone's already said so but you've done a really fantastic job. I hope you're able to take a lot from today with your case. Please be on the lookout for emails regarding credit claiming for your participation in the series. But I just wanted to take a quick moment to thank each and every one of you for your participation. Because truly, we would not have been able to put this on without you all. I've had a tremendous time and I hope you all were able to learn something from this. With that I will leave you all to the rest of your day.
Lal: [1:01:53] Thank you for organizing it, Andrea, appreciate it.
Quiles-Sanchez: [1:01:57] Bye everyone.
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The following faculty reported relevant financial relationships: Elizabeth Beverly, PhD - Journal of Osteopathic Medicine, Section Editor. Nicolas Cuttriss, MD - ENDO Diabetes & Wellness, Employer; ECHO Diabetes Action Network, Employer; The Leona M. and Harry B. Helmsley Charitable Trust, Consultant; Cecelia Health; Consultant; American Youth Understanding Diabetes Abroad, Board. Kate Kirley, MD - American Medical Association, Employer. Rayhan Lal, MD - Abbott Diabetes Care, Consultant; Biolinq, Consultant; Capillary Biomedical, DSMB; Deep Valley Labs, Consultant; Gluroo, Consultant; Provention Bio, Advisory Board; Tidepool, Consultant. Jay Shubrook, DO - Abbott Diabetes Care, Consultant and Advisor; NovoNordisk, Consultant; Astra Zeneca, Advisor; Bayer, Advisor; Eli Lilly, Advisor; Nevro and Nevro, Advisor.
The following faculty reported no relevant financial relationships: Christopher E. West, PhD, A-GNP-C
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