Hello, welcome to the A ANP meeting and to our presentation, Early use of CGM in type two diabetes. I'm DaVita Kruger. I'm a certified nurse practitioner at Henry Ford Health Systems in Detroit, Michigan. Let me start by talking about late breaking trials on CGM directed glycemic management, patient safety and resource utilization across the nurse practitioner settings. And thank you. Well, again for joining me, that sucked. Ok, I just have to get a restart. Let's start over, let's do a restart. Ok. Take your time. Hello, I'm DaVita Kruger, a certified nurse practitioner at Henry Ford Health Systems in Detroit, Michigan. I'm at the A ANP meeting and it is my pleasure to welcome you to our presentation on early use of CGM in type two diabetes. My first presentation today will be on the late breaking trials and guidance for initial intervention in type two diabetes. These are my duality of interest or conflict of interest. So let's might start by talking about guidelines for use in CGM. Now, I've been in the, 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 two 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 Ameri 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 could 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 Sulfon urea and we had urine testing. Now we have so much more to offer and we know type two diabetes with type one 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 sulfon urea and those sulfon urea 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 one or type two. And there's enough clinical research to show you that the earlier you provide that intervention, the better the A one C, 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 one and type do 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 100 and 80 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 finger stick data to continuous glucose monitoring? Well, this shows you that we'd really like to see all of the blood glucose is between 70 100 and 80. And we want that tightly controlled between 7080 without a lot of variability because it's a variability that causes the complications with the high postcranial blood sugars and it's exhausting for our patients. What this is showing you is this, this particular patient did four 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 post cranial 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 four 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 100 and 80 while he had eaten an orange and hadn't washed his hands. So his eight, his orange blood sugar is 400. His body was 100 and 80. 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 hyperglycemia. Here's the other issue with um just a one C. We can't define treatment just by a one C. 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 4400 and it averages out to a good A one C, I wouldn't know that without the data and it doesn't indicate the extent or timing of hypoglycemia, hyperglycemia. The big issue I find is a 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 eight or nine A seven, 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, hemoglobin, opathy, iron deficiency pregnancy. Remember in pregnancy, we want their A one C to be 6.5 before they get pregnant and then less than six when they're pregnant, why this is the turnover of the red blood cells? So anything that affects the red blood cells affects anger stick data as well as A one C. And then um correlation with the mean blood glucose can vary um across um all kinds of different things for our patients. And um I 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 A one CS are not equal um, across patients. All three of these patients have an A one C of 71 has time in range of 100 63 and 24%. Look at patient c 18% hyperglycemia, 58% hyperglycemia averages out to be a nice A one C but in reality, this is not good, good glucose control. Keep in mind too that, um with each five percent increase in time and rain, that is clinically beneficial to the outcome of your patients. So if you start a patient on a sensor, their 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. Two 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 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 7180 is what we want and uh less than 5% low. So 4% less than 71% less than 54 less than 25% high. How does that, um, come out to be the time of day? How many hours in a 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 in range with less than 5% low. Ok. So why are we talking about this? Remember, I said when I first started that, um, type two diabetes was not a serious disease. Well, we have medications that can control type two diabetes. We have CGM, we use insulin pumps in type two diabetes and we need to be more aggressive. So here's the legacy effect metabolic memory. We know that if the A one C 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 A one C does not come down or we're not aggressive enough with adding uh an SSGLT two inhibitor or a G LP one, we have to be aggressive. Well, if we have that. Those patients with A one C is greater than equal to 616 6.5%. In the first year after diagnosis. It is associated with a 20% higher risk for both micro and v macrovascular events and 29% higher risk of mortality is associated with an agency between seven and less than 8%. And a lot of times we don't think about 7 to 8 percent being that detrimental. Oh, we'll get to that. A one C will be more aggressive. You don't have time, you meet that patient, you give him CGM immediately and you're aggressive with the medications. But, um, the mortality rate of 29% higher or 7 to 8% versus an A one C 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 P DS. 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 UK P DS saw the metabolic memory benefit for 44 years. Ok. So post paintal blood sugars, that's the first place you lose your insulin response. And it happens very early in the stages of type two diabetes. And we talk a lot about the stages recently of type one, but we need to remember the stages of type two diabetes as well. It can be easily detected and identified how with continued glucose monitoring. It occurs very frequently in type two diabetes. And we're not looking because we're not doing finger sticks enough if we're doing finger sticks, because we're not looking at the post brandy 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 ac GM, 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 post cranial hyperglycemia is predictive for the risk of diabetes complications including the increased cardiovascular mortality, microvascular complication, 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 catch 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 one and type two. And I was privileged enough to be an investigator in both of those studies. So why is this important? Because 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 one individuals on an in 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 two diabetes benefit from CGM, it lowers their A one C, they like it, they will wear it. So this was finger stick data versus CGM. And you can see that there was an improvement in the A one C at week 12 and at week 24. So the change continued. This is the mobile study and this was done in individuals with type two diabetes on basal only insulin. Again, we have to stop thinking of um CGM being only for multiple daily injections or four insulin pumps. And you can see that the A one CS 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 A one C better time and range and better uh time, less time above uh range all happened, patients on basic insulin, not only and we weren't adjusting the insulin in the study because I was investigated for this as well. What we were doing was giving them CGM. And we saw about behavior modification because the patient could see the data and learn from their data. And this was um a study and you see that uh 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 eight 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 A one C 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 two diabetes. He took them with a one CS of 10.4% and 9.5%. And all he did was give them CGM. And what happened in the first three months? The A One CS went down between two and 3%. Continue to go down by six months. They were, um, 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 A GP 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 CG MS use. It's a standardized report. The first bar is your metrics. It tells you your time and range time below. It tells you um your average glucose, the, the middle bar is your A GP. You want everything between 7180. Those are the two green bars. You can quickly see the red is your hypergly issia. Anything that's not green is hyperglycemia and it takes, it takes two 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 D and see if it is two days or more um out of the, the se the 14 days if there's a pattern. And I can see quickly that it was two days causing that hypoglycemia. So I just put this in my talk because I want to remind you that A one C is not, that hypoglycemia is not defined by A one C. And you can see that the individuals whose A one CS 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 stop their therapy because of the fear of hypoglycemia. And also someone standing behind at every six, at six 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 two diabetes report at least one severe hypoglycemic event that means someone has to help them. Hypoglycemia does occur in type two diabetes and it is not dependent on the A one C. Thank you so much. And I'm gonna turn this over to Lucia.
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