Hello everyone. My name is Diana Isaacs. I'm an endocrine pharmacist and also the Director of Education and Training in Diabetes Technology at Cleveland Clinic, and I am very excited. Thank you all for being here because I am the one that gets to talk about a brand new feature called SmartBasal. And I've gotten to be one of the people to early pilot this, and this is something that's going to be available to all of you very soon. And so these are my disclosures. I also speak and do everything diabetes, so you can see that.
But let's take a step back for a second. And we just talked, we heard all this great information from Dr. Shaw about reclassifying type 2 diabetes, and we just spent all this time learning about Stelo and how it can really help people with lifestyle. And we're here at the ADA Scientific Sessions where there's all this new data about these incretins, these GLP-1 drugs that are going to have up to 30% weight loss and all of this A1c lowering. So do we really need insulin?
Yes, unfortunately, we do need insulin because you saw from Dr. Shaw the progressive nature of type 2 diabetes. And even when people are diagnosed right now with so-called prediabetes, they have already lost some of their beta-cell function. And we have kids, teenagers, young adults now being diagnosed with type 2 diabetes. What happens when they've lived with it for 10, 20, 30, or more years? Their beta-cells stop functioning, and they do need insulin to reach their goals. And insulin is, in many ways, an incredible drug because it has no max to A1c lowering. However, in the clinic, it is very challenging to use. And because of that, lots of patients are not taking the prescribed dose that they have, and we are seeing that most people are actually not reaching their A1c and their time in range goals.
So you can see we have a real opportunity here to do better.
So let's talk a little bit about therapeutic inertia, right?
So what is happening? Well, unfortunately, by the time we even think to start insulin, many people are creeping up with A1cs getting close to 10%. And I think we heard from Dr. Barron, it's like kicking the can down the road. Can I do more with lifestyle? Can I do this? Can I do that? Can we try this? But the reality is people are developing complications during that time. They have higher risks of heart attack and heart failure and stroke. And we know that if we can treat early, we can reduce those risks. So what is going on? Why is this so hard? Well, it turns out one of the big barriers is hypoglycemia, right? It's challenging to titrate insulin because if you get too much, you can experience hypoglycemia, which can be life-threatening and as a pharmacist, I know that insulin is a drug with a very narrow therapeutic window. And so while it's very effective, there is unlimited A1c lowering that if you get too much, you can have severe hypoglycemia. And if you don't get enough, you can have all of these complications.
And that is where we are introducing today the Dexcom SmartBasal, which is a new digital tool here to overcome this therapeutic inertia.
And you know what? There's many reasons for therapeutic inertia. It's not any person's one fault. When it comes to the healthcare professional and the health system, there are system-level barriers, right? Like we might get 15 or 20 minutes with a person. How are you supposed to introduce insulin, get them on board to start taking it, teach them how to inject, right? It's a lot easier to delay it. We finally start someone, right? And we start at that 10 units, right? That 10 units. And then we wait till they come back to titrate it, but then three months turns into six months, turns into 12 months, and then maybe they had one low event and were afraid to go up on the dose, and so they stay at 10 units for years, right? And so there's just so many reasons it doesn't happen. Also, on the patient side, there's a lot of barriers too, right?
People come in, they have these negative connotations with insulin. They might have had a family member who, oh, they started insulin, and I remember they needed a transplant right after that. Or they ended up getting their foot amputated. I don't want that insulin. I don't want anything to do with it. Or sometimes there's some stigma associated with it. Some people have been told earlier in their lives, "Oh, if you don't do what you're supposed to do, you're going to need insulin." And so that stays with them. And now they don't want to take it because they feel like they are a failure, like somehow they didn't do what they were supposed to do, even though type 2 diabetes is a progressive condition. You could do everything you're supposed to do and still need insulin, and that is okay. And then I also think that fear of hypoglycemia is very real, and we of course, need to be able to address it.
So one of my favorite studies of all time is the MOBILE Study. Why is this my favorite? Well, this was, I think, really the study that led to Medicare covering CGM for people on basal insulin with type 2 diabetes. But this was really a very nice study. This was a randomized controlled trial that compared CGM to BGM in basal insulin users. So they were not on mealtime insulin, but they were on other non-insulin agents. And it showed us, wow, CGM makes an incredible difference. When you compare to the control group, there was a 0.4% greater A1c lowering. There was 15% more time in range, right?
So why do we need anything else? Isn't CGM alone enough?
Well, turns out not exactly, because when you break down the data, actually, about one in five people was at an A1c of less than 7%. Now, that's way better than the one in 20 in the control group. But not everyone had that A1c less than seven. Also, it's very interesting because when you compare the two groups, you might think, oh, well, would there have been more medication adjustments in the CGM group? There was not. There was probably some therapeutic inertia there despite having the data, the CGM data, there weren't higher doses of insulin, there weren't more medication changes. So I would argue this is very compelling to say, you know what, CGM is great, but we need something a little more for people that are on basal insulin.
All right. So what does the ADA standards of care say about starting insulin and adjusting it? This is taken straight from my favorite chapter, Section 9 on the Pharmacologic Management, and it guides us, right? Pretty simple. You start at 10 units. If you want, you could do weight-based dosing, 0.1 to 0.2 units per kilogram, right? How do we adjust it from there? Well, you could follow a weight-based thing. You could do maybe two units every three days until you get your fasting below 130, or you could do 10% to 15% twice a week. You could go up two to four units once or twice weekly until you get down to 80 to 130. And then if there's any hypoglycemia, if you can identify the cause, great. But if not, decrease by 10% to 20%.
Oh, my goodness, who's supposed to do that? Who's supposed to follow the patient that closely? Who's calling them once or twice a week? And yes, we have some savvy individuals with diabetes where we might give them some guidance, but many of them, they're like, "Wait, this is too much. I'm just going to wait until my next visit." And for this reason, people either end up on 10 units, or in some cases, people end up overbasalized, and we just go up and up and up and up, and they're going low, and we don't even realize it.
So this is really why SmartBasal was developed, and this is designed to be a simple CGM-guided long-acting insulin adjustment, and this works through Dexcom Clarity with the Dexcom G7 15-day CGM.
I do want to highlight that this is designed for adults because right now the Dexcom G7 15-day is also designed for adults.
And I'm going to walk through some of the screens. So you start this, you can access this directly in Dexcom Clarity. And you go ahead, you can see in there, there's that little basal, the SmartBasal. And when you have access to this, you can see that feature, and you can go ahead and create a plan for someone.
So that is step one. You're going to go ahead and create that plan. And one of the things you will notice when you do this is this is designed for insulin glargine U100. Now, glargine U100 comes in many forms. There's Lantus, there's Basaglar, there's Rezvoglar, there's Semglee. So all of those are fine, but it should be glargine U100 insulin.
And then you're going to go ahead and you're going to create your treatment plan. And it even guides you on how to do this. You could do your typical 10 units, or you could do a 0.1 to 0.2 units per kilogram to start. And it provides guidance that, hey, if the A1c is over 9%, maybe you want to start directly with 0.2 units per kilogram. If the A1c is less than nine, maybe you want to start with 0.1.
And then you're going to go ahead, put that initial dose in, and when you put the initial dose in, it will even tell you what that ends up being. Was it 0.1 units per kilogram? Was it 0.15? So you can double-check. And then you get to decide the maximum dose. And one of the things I like to do, because I've gotten to try this early with some of my patients, for that max dose, I like to do around 0.5 units per kilogram per day because I don't want my patients to end up overbasalized, although I'm pretty confident with this app that wouldn't happen anyway. And then you can adjust it. So you can go ahead and adjust it. You can decide the increment it will increase and then also decide for hypoglycemia for 15 minutes of the time in hypoglycemia, it will be able to decrease that. And I like that it's 15 minutes. It's not just a quick blip. It is for 15 minutes.
So then you're going to go ahead, you're going to invite your patient, and when you do this, it's going to have a set of instructions which you can print for the person, you can send it to them if you're doing a virtual through MyChart, or you can just give them this code because in their app, they just need this code.
And so in terms of what it's going to look like in the app for them, they're going to go ahead, they're going to be able to log their dose and get reminders. And I'm going to go ahead now and show you on the patient side what this actually looks like for the person with diabetes. So you're going to go ahead and you're going to connect the patient with that code. So they're going to go into their app, into that SmartBasal, and they are going to enter in this code, and then they're going to do their insulin dose timing and setup. And you've already decided the starting dose. You let them know that, and then they can set the time that they're going to take it. I like to toggle the reminder on because with this app, it's really important that we log it. And so we do want to remind people to look at it at the dose that's recommended and then just log that they have taken it.
And that's the reminder that they will get. They can always go in early, though, and do it, so if they don't want their phone to beep at them and get that reminder, if they do it before the time, that will not happen. And they'll get that dose recommendation, and then they will be able to log that dose. Let's just say they said, "I don't want to do this dose." They can log a different dose. We wouldn't recommend that, but it would show up, and we would be able to see that.
And so that's what it's going to look like for them. All right.
So what I want to close off with is actually two patient cases illustrating how we use this, how this works.
So this is the first patient. We have a 40-year-old male, has had type 2 diabetes for eight years, is on an SGLT2 inhibitor, GLP-1 agonist, and metformin, but A1c is 8.5% and just not at goal. So the decision is made to initiate basal insulin. And this person's already using CGM. We can see at baseline, 37% in range and averaging about 216, and really that whole curve looks to be elevated. It's pretty clear this person would benefit from insulin.
So how do we start? Well, the decision was made, you know what? We'll start with 10 units, and we will titrate up.
And what you are seeing here is the titration over the time period. This can go up to 90 days, but many people don't need 90 days to get to their optimal dose.
What I find so fascinating, and I've seen this with my patients as well, is that, look, the dose goes up, but then sometimes it comes down, and then it actually got higher, but where it landed on at 29 units wasn't the highest point. And I think it's really fascinating because when you don't have a tool like this and you're just seeing them at one visit, you could really make a wrong assumption. Maybe you're seeing them when they're running higher, and you end up titrating it too much. And then they have hypoglycemia, and then they stop taking their insulin at all because they're having hypoglycemia. So I think having this daily titration is really, really useful.
And what we're looking at now is this was the before and this was the after. So starting off at 37% in range and then ending up at 75% in range. And all of this happened without increased healthcare visits, without having to call and follow up. At this follow-up visit, the person was titrated and at goal.
Now, I want to share another case. This one was a little bit more extreme hyperglycemia, and this is a 74-year-old female who's had type 2 diabetes for seven years. So on an SGLT2 inhibitor, already on insulin glargine 20 units. So coming to us on 20 units of insulin glargine, didn't tolerate, couldn't be on a GLP-1 drug. Had a liver transplant in the past, also has some pancreatic insufficiency, and on a variety of different medications as well. A1c has really been fluctuating between 8.9 and 10.8. And we look at this picture, and it's like, are you taking insulin? What's going on?
And really struggling. So we ask if she's willing to try this tool, and she is. And so we keep it at 20 to start. I suppose we could have maybe increased it to 22 or 24 to start. But look, this is really amazing that it kept her at the 20 for a few days, and then we could see it went up, and she actually landed on 37 units at 32 days. And I think it's really interesting because I don't know, based on how high it was to start, I would've maybe thought that she had needed more.
But also, the advantage of this is that it is reminding someone to take their insulin every day, and there's some accountability that we also know that she's taking it every day and not missing doses. And here is the before, and then there is the after, where we can see 60% in range. She is in her mid-70s, so we could perhaps shoot for 50% or more time in range, A1c goal less than 8%.
So some of the key takeaways that I want to leave you with for this part is that many people with type 2 diabetes benefit from insulin to manage glucose levels. I love all the latest and greatest incretins, but many people benefit from insulin, and we need to find safe ways to get them that insulin. Personalization is really key. One size does not fit all. That's why we want to have options. And overcoming therapeutic inertia. There is so much inertia. There's inertia in diabetes, right? Making those lifestyle changes is hard, and CGM has demonstrated to help that. But then you get into insulin, and it's like this whole new therapeutic inertia with additional barriers of hypoglycemia. And through the combination of CGM to have those alerts and now the digital tool to help with insulin titration, we can get people to goal, and then we can prevent all of those potential diabetes complications and improve people's quality of life.
