Hello, I'm Davita Kruger, a certified nurse practitioner at Henry Ford Health Systems in Detroit, Michigan. I'm at the AANP meeting, and it is my pleasure to welcome you to our presentation on early use of CGM in type 2 diabetes. My first presentation today will be on the late breaking trials and guidance for initial intervention in type 2 diabetes. These are my Duality of interest or conflict of interest. So let's start by talking about guidelines for use in CGM. Now, I've been in the business for the last 42 years of diabetes. I only see people with diabetes, and when we first had CGM was close to 20 years ago. And we wanted them so bad because people don't like to do finger sticks, and we weren't getting our data, and we're missing so many places where we can't see what's going on with the patients. So over the 20 years, the guidelines have evolved, and the way we manage type 2 diabetes and diabetes in general has changed. But all of the diabetes organizations are saying, please use CGM in your clinical practice. And specifically the American Diabetes Association's Standards of Care for 2024 talk about devices should be offered to people with diabetes. And we're talking more about both type one and type two. When I first started diabetes, we thought type two diabetes was not a serious disease. You can allow people to be sweet. Well, we did that. Unfortunately, patients got complications. Why did we do that? We didn't have anything to offer. We had mixed beef, pork insulin, we had sulfonylureas, and we had urine testing. Now we have so much more to offer and we know type 2 diabetes with type 1 diabetes is a serious disease. So, we want you to offer real-time CGM or intermittent scan. And we wanted to offer to all individuals on insulin, basal insulin, multiple daily, or on insulin pump, or if they are at risk for hypoglycemia, there are people out there that are still using sulfonylureas, and those sulfonylureas will cause hypoglycemia. So if you have a patient on that, you might want to think about using CGM. And you want to initiate it early in the diagnosis of their diabetes. Again, whether it be type 1 or type 2, and there's enough clinical research to show you that the earlier you provide that intervention, the better the A1C, the better the lowering of the blood sugars, the better the time and range, hence less complications. This is just a slide to show you the options available, and you can see there's a lot of choices out there for personal CGM. So, the first two columns, the first one is the Libre group, the second column is the Dexcom group, and both of these can be used um every day for our patients with diabetes type 1 and type. You don't have to do a finger stick. You do not have to calibrate these, um, and they are covered by Medicare, um, and in some states by Medicaid as well. The next column is, um, the guardian grouping. Most of those are for insulin pump, uh, connectivity. The guardian connect is available. For stand-alone, however, it still has to be calibrated with finger sticks, and it's not covered by Medicare. And going back to the first two columns, those sensors can also be integrated with numerous insulin pumps, meaning that the data is so accurate that it can tell the pump what the blood glucose is, and the pump doses insulin based on it. And then the final column is your implantable continuous glucose monitor. It's for 90 or 180 days, however, you still have to do finger sticks, and there's an external transmitter. Options and choices, great coverage in 2024. Um, you shouldn't say, oh, I can't get coverage for my patients. We'll talk a little bit about that later on. It's really good for both type one and type two diabetes. So, why do we want to move from fingerstick data to continuous glucose monitoring? Well, this shows you that we'd really like to see all of the blood glucoses between 70 and 180. And we want that tightly controlled between 70, 80 without a lot of variability, cause it's a variability that causes the complications with the high postprandial blood sugars, and it's exhausting for our patients. What this is showing you is this this particular patient did 4 finger sticks. The finger sticks all look great. They're before meals and before bed. Nobody would guess that this patient might have hypoglycemia or that this particular person might have postprandial hyperglycemia. But if I superimpose a continuous glucose monitor, look what I find. Nocturnal hypoglycemia undetected by the patient, hyperglycemia after breakfast, after dinner, after lunch, also undetected by the patient, because that's not where they're looking. Now, if I was given those 4 blood glucoses and that's all I had to go on. I would say you're doing great, and this patient is not doing great. There are other issues with finger sticks, whether the patient's hands are clean, are the strips out of date, are they accurate? I had a patient call me and said there's something wrong with the right side of my body. Why, John? Every finger on the right side of my body says my blood sugar is over 400. Well, what did you eat? What do you mean what I ate? My left hand says. My blood sugar is 180. Well, he had eaten an orange and hadn't washed his hands. So his oranges blood sugar is 400, his body was 180. So we're not getting the data we need. It's not actionable. I don't know what to do with this, unless I was desperate and just had to say, could you maybe check occasionally two hours after a meal? Could you occasionally check during the night? So undetected hypoglycemia, undetected hypoglycemia. Here's the other issue with um just A1C. We can't define treatment just by A1C. Uh, it may underestimate or overestimate glucose control because 7% represents good, fair, and poor control, depending on where the spectrum, and remember it's a 30 to 90 day average. So if the patient is 40 and 400 and it averages out to a good A1C. I wouldn't know that without the data, and it doesn't indicate the extent or timing of hypoglycemia or hyperglycemia. The big issue I find is the patient who says, I never have any hypoglycemia, never, never, never, never, and you put a sensor on them and you're like overwhelmed at how much hypoglycemia they had, undetected, unfelt. Um, no, the variability, uh, the roller coaster effect, you wouldn't know, limit, limited, uh, utility for dosing decisions. I honestly, if you give me an 8, a 9, a 7, how do I know where there's an issue with those blood glucoses or that data so that I can adjust that person's medication. And then if you have a person. With hemolytic anemia, hemoglobinopathy, iron deficiency, pregnancy. Remember in pregnancy, we want their A1C to be 6.5 before they get pregnant, and then less than 6 when they're pregnant. Why? Because of the turnover of the red blood cells. So anything that affects the red blood cells affects finger stick data as well as A1C. And then, um, correlation with the mean blood glucose can vary, um, across, um, all kinds of different things for our patients, and, um, in, in different race groups and ethnicities, we see a difference as well. We did some research and we were able to prove that as well. So, while we're not throwing the baby out with the bathwater, we're not inviting him home to stay anymore. OK. And this just shows what I've been saying is that A1Cs are not equal um. Across patients. All three of these patients have an A1C of 71 has time and range of 100, 63, and 24%. Look at patient C, 18% hypoglycemia, 58% hyperglycemia averages out to be a nice A1C, but in reality, this is not good good glucose control. Keep in mind too that um with each 5. 0% increase in time and range that is clinically beneficial to the outcome of your patients. So if you start a patient on a sensor, the time and range is 24%. They get it up to 30%. That's great in terms of the benefit overall. Obviously, that's not where we're going to leave the patient, but it's a start, and patients watch the time and range, and that for them is really helpful. To, as they learn and grow what they're looking for, and they can say, they'll say, oh, you know, my time and range used to be 60%, now my time and range is 75%, and that's actionable for them, uh, to follow their data. So if you want to relate it back to what's going on for a 24 hour period, um, look at this. If 70% time and range, 70 to 180 is what we want. And uh less than 5% low, so 4% less than 70, 1% less than 54%, less than 25% high. How does that um come out to be the time of day, how many hours in the day? So, if the patient spent that much time in range, which is exactly the breakdown we're looking for. Or at least 70% time in range. That's 17 hours in target and less than an hour below range. Now, in a perfect world, we'd have nothing in the low range and we'd have more time in range, but this just gives you an idea if you're able to achieve 70% time and range with less than 5% low. OK, so why are we talking about this? Remember I said when I first started that um type 2 diabetes was not a serious disease. Well, we have medications that can control type 2 diabetes. We have CGM. We use insulin pumps in type 2 diabetes, and we need to be more aggressive. So here's the legacy effect, metabolic memory. We know that if the A1C is greater than or equal to 6.5%. In the first year after diagnosing, which happens very often because we start a patient on metformin and we forget about them or they don't come back, they're lost to follow up and their A1C does not come down or we're not aggressive enough with adding an SGLT2 inhibitor or a GLP-1, we have to be aggressive. Well, if we have that those patients with A1C is greater than or equal to 6166.5%. In the first year after diagnosis, it is associated with a 20% higher risk for both micro and macrovascular events, and 29% higher risk of mortality is associated with an A1C between 7 and less than 8%. And a lot of times we don't think about 7 to 8%. 0% being that detrimental, oh, we'll get to that A1C. We'll be more aggressive. You don't have time. You meet that patient, you give them CGM immediately, and you're aggressive with the medications, but um the mortality rate of 29% higher or 7 to 8% versus an A1C of less than 6.5%. And then it's really immediate that you do this intensification because 25% reduced risk of microvascular disease with early intensive therapy, which was seen in UK PDS. And here's the other thing is that once the patient gets into that tight control early on, the metabolic memory, the body remembers it, so. Even if they're later on, they, something in their life keeps them from doing that, they will keep, uh, they will, they will have the body will remember that for longer, and they'll get the benefit of that metabolic memory. And in the, um, in this particular study, those individuals in the UKPDS saw the metabolic memory benefit for 44 years. OK. So postprandial blood sugars, that's the first place you lose your insulin response, and it happens very early in the stages of type 2 diabetes. And we talked a lot about the stages recently of type 1, but we need to remember the stages of type 2 diabetes as well. It can be easily detected and identified how with continuous glucose monitoring. It occurs very frequently in type 2 diabetes. And we're not looking cause we're not doing finger sticks enough if we're doing finger sticks, cause we're not looking at the postprandial and we're not giving CGM early enough, and it's affected by meal timing, amount of food, and timing of meals. And here's what happens. If you give someone a CGM, you have behavioral change. CGM has to be the same as when we think of CGM we think of behavioral change. There. They're, they're just locked together. So postprandial hyperglycemia is predictive for the risk of diabetes complications, including the increased cardiovascular mortality, microvascular complications, cognitive decline, and cancers, and we don't stress that enough, and we don't, we need to start even sharing that with our patients more so they understand why you need to wear a sensor. We need to get you on another medication. I need to see you in follow-up. So here's the first study I want to talk to you about. This is the diamond study, and the diamond study was done in type 1 and type 2, and I was privileged enough to be an investigator in both of those studies. So why is this important? Cause it was the first time we said maybe people that are not on insulin pumps need to be wearing CGM as well. Up until the diamond study, we only gave CGM to type 1 individuals on an insulin. And pump, sort of like the chicken and the egg is how I think of this study and now we know that uh not only do people who have type 2 diabetes benefit from CGM, it lowers their A1C. They like it, they will wear it. So this was fingerstick data versus CGM, and you can see that there was an improvement in the A1C at week 12 and at week 24. So the change continued. This is the mobile study, and this was done in individuals with type 2 diabetes on basal-only insulin. Again, we have to stop thinking of um CGM being only for multiple daily injections or for insulin pumps, and you can see that the A1Cs for these individuals went from 9.1% down to 8% in the first eight months. Time and range went up to 59% versus. 43% and then um greater than 250 time um above range went down to 11%. So better A1C, better time and range, and better uh less time above range all happened. Patients on basal insulin, not only, and we weren't adjusting the insulin in the study cause I was an investigator for this as well, what we were doing was giving them CGM and we saw the behavior modification because the patient could see the data and learn from their data. And this was um a study you see that the patients it's the same study I just showed you the mobile study, but it was an extension. The orange is blood glucose, the dark blue is CGM, and the lighter blue is discontinuation of the CGM. So the 8 month is when the CGM was discontinued. From the light blue group and you can see the time and range went down immediately and the A1C went up. Patients were using it again, no medication adjustments. Patients were using the data um on an everyday basis to improve their outcome. And this is one of my favorite studies. This is done by Doctor Grace um in Ohio. Um, he took patients who are on one therapy or 2 to 3 therapies, did not adjust any therapies. They had type 2 diabetes. He took them with A1Cs of 10.4% and 9.5%, and all he did was give them CGM. And what happened in the first three months, the A1Cs went down between. 2 and 3% continue to go down by 6 months they were below 7%. Again, it's behavior modification that the CGM allows the patient to own their own diabetes and make changes in their life. Um, this is the AGP report. Um, I'm just gonna briefly go over this because Lucia, who's speaking with me, Novak will go into greater detail. But this is um a report that all of the CGMs use. It's a standardized report. The first bar is your metrics. It tells you your time and range, time below. It tells you your average glucose. The the middle bar is your AGP. You want everything between 70 and 180. Those are the two green bars. You can quickly see the red is your hypogly. Glycemia, anything that's not green is hyperglycemia, and it takes, it takes 2 weeks. It makes it look like 24 hours, so you can wrap your head around. I can tell you overnight this patient's having hypoglycemia, and then uh you can go down to the dailies and see if it is 2 days or more um out of the, the, the 14 days if there's a pattern, and I can see quickly that it was 2 days causing that hypoglycemia. So I just put this in my talk cause I want to remind you that A1C is not that hypoglycemia is not defined by A1C, and you can see that the individuals whose A1Cs are less than 6% or those greater than 14% have the same amount of hypoglycemia. Why? Probably because the people that have 14% of having a lot of hypoglycemia with their therapy, they stopped their therapy because of the fear of hypoglycemia, and also someone standing behind them. At every 6 at 6 o'clock every day feeding them because at 5:45, 6 months ago they had hypoglycemia. So they lower their medication, they don't take their medication, they're eating to keep up with the hypoglycemia versus people who are at treatment goal, and 11% of individuals with type 2 diabetes report at least one severe hypoglycemic event. That means someone has to help them. Hypoglycemia does occur in type 2 diabetes, and it is not dependent on the A1C. Thank you so much, and I'm going to turn this over to Lucia.
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