thank you so much for that kind. Introduction Professor Sarah Hamil absolutely delighted to be here today in Stockholm. How nice to have everybody together in the conference face to face again. I can't tell you how much I have missed this while. I'm delighted over the next 20 minutes to be sharing with you the rationale for flash locals monitoring across the full spectrum of diabetes care. With particular focus on the endpoints in type two diabetes. These are my disclosures. So we're going to consider the role of continuous glucose monitoring. But thinking from the perspective of a person living with diabetes and then I'll go on to share the clinical outcomes of flash glucose monitoring across the spectrum of diabetes care. I want to start by asking you to cast your mind back to the 1970s and 80s when there was that transition from urine to blood glucose monitoring and it was a challenge. People reported that patients wouldn't understand what to do with the data. It was too expensive. Health care professionals wouldn't understand it. But of course, blood glucose monitoring became the standard of care Fast forward to 2014 and we saw the advent of flash glucose monitoring. And actually many of the challenges from the 70s and 80s with that transition were reflected in this era. I'm delighted that here we are in 2022 and we are moving to the point where interstitial glucose monitoring is becoming increasingly accepted as the standard of care. Now. If you don't live with diabetes, it can be difficult to understand the sort of difference that this data makes to your life from day to day. So I've tried to come up with an analogy to take you to a place where you understand how the person with diabetes might feel and the difference that continues local data makes in their life. So, I have a challenge. I would like to challenge you to drive to part role in London in the UK. And you say to me, well, m I've never been there before. How do I get there? You're going to use your sat nap of course. But what if I said to you, you can only use your satnav four times along your journey. Feeling uncomfortable. Well, so you should be. This is exactly what we have been asking people with diabetes to do for decades. But of course what they really want to be able to do is have unlimited views of their glucose data just as you would want unlimited views of your SATnav along your journey, checking in on where you are, what direction are you going in and how is the journey going? And this is the difference that continuous glucose data makes to people living with diabetes. Whether it's type one diabetes or type two diabetes is understanding where you're at to give you further insight on the impact that continuous glucose data makes on decision making In the UK. You need to have a glucose of five or above to be safe to drive a car. So here we have a blood glucose of 5.3 safe to drive a car. Why? Yes, you tell me Here's flash glucose data. 5.3 safe to drive a car. But what about this scenario 5.3 and dropping rapidly. Still safe to drive a car. So hopefully you can start to see the impact that this has on the immediate decision making in the life of the person living with diabetes. And actually here we are where nice have very recently recommended that there should be the standard of care for everyone living or type one diabetes. And they are now recommending either flash or real time. See GM to every person with type one diabetes and the choice of the device should be based on preference need characteristics and the functionality of the device. And in the UK we have certainly recently gained real insight into the difference that flash glucose monitoring to make in terms of outcomes. Here we have follow up data published in diabetes care in 2020 from over 3000 people predominantly living with type one diabetes. And we looked at a range of outcomes at 7.5 months of follow up. We saw a substantial reduction in HB one C of 5.2 or 0.5% HB one C. But interestingly in those with impaired awareness of hypoglycemia, 53% actually improved their hyper awareness and had normal hipAA warning act follow up. We also saw a significant improvement in diabetes related to stress. But one key advantage of real world data over randomized control. Trial data is the ability to evaluate real world acute events. And we saw substantial reductions in admissions with DK hypoglycemia reductions in paramedic call outs and a substantial reduction in severe hypoglycemia. So, I think we're all convinced of the need for this data in those with Type one diabetes. But where are we in Type two diabetes? So I'll walk you through the current evidence for flash glucose monitoring in people living with Type two diabetes. So if you cast your mind back to 2017, this is the first randomized control trial all flash glucose monitoring and people living with Type two diabetes. These were people on intensive insulin therapy from across 26 european centers and they compared flash glucose monitoring to self monitoring of blood glucose with a primary outcome of HB one C. At six months. Although the primary endpoint was not met with no difference in HB one C. Over all those in the age group less than 65 years did see a significant improvement in H. B. O. And C. Of 00.33%. There is also a substantial improvement in treatment satisfaction. But for me what's really striking is the improvements in hypoglycemia and if you cast your eyes to the bottom of the slide. You see that we get a 43% reduction in level one hypoglycemia less than 3.9 very much reflecting the data that we saw from impact their RCT and those with type one diabetes Moving on. Yaron and colleagues also did a randomized control trial this time and people with type two diabetes on multiple daily injections comparing flash to random blood glucose monitoring with the primary outcome of diabetes treatment satisfaction. And although they just failed to meet statistical significance for the primary outcome. Looking at sub elements, they found that flash glucose monitoring was associated with high satisfaction, more flexibility and generally they would be recommending it to their counterparts. This trial also showed a significant improvement in HB one C. And those on flash glucose monitoring with an H. B. O. And C reduction of 00.82 compared to 0.33 in the control arm. And then we move on to wada's randomized control trial this time in non insulin treated type two diabetes. In a range of hospitals in Japan where people were randomized to flash glucose monitoring or self monitoring of blood glucose for 12 weeks. But they were interested to understand the longer term impact of those 12 weeks on flash glucose monitoring. So they followed up to 24 weeks to understand the longer term impact. The primary outcome was changed in HB one C. Now if you look here, if we remember that during that 1st 12 weeks people in the intervention arm and Orange had access to flash glucose monitoring and by 12 weeks. Although there was no significant difference in H. B. L. And C. At this point, what's interesting is that by 24 weeks and remember that during the 12 to 24 weeks both arms were on blood glucose monitoring. We see a significant difference in H. B. N. C. At 24 weeks. There were also significant improvements in treatment satisfaction, glucose glycemic variability and time and hyperglycemia. So here we have the overview of the randomized control trial data, some evidence supporting reduction in H. B. O and C replace supporting improvements in hypoglycemia and some supporting improvements in treatment satisfaction. But what about real world insights you and I know that often the people that we see in clinic are not necessarily represented in randomized control trial and that's where we go to real world insights to understand what's happening in the real world. Well, we have the slayer nl four. This was a perspective nationwide registry people were using flash glucose monitoring for 12 months and although only 16% had Type two diabetes, I think this gives some really useful insights. There were improvements in hB one C hypoglycemia and something really interesting which often isn't reported a significant improvement in work absenteeism rate over six months. They also reported an improvement in diabetes related hospital admission rates. Moving on to look across europe and their insights here we have data from a retrospective chart review study in adults with type two diabetes on basal bolus insulin with an HB one C between eight and 12% across Austria France and Germany. And again, we're getting consistent message in here about reductions in H B. O and C. Across those three countries. Similarly, we have data from the USa here. Eugene right looked at the IBM explorers database to assess changes in HB one C after flash glucose monitoring prescription. In a population with Type two diabetes under the age of 65 they looked at those on basal insulin or non insulin therapy who had an elevated H. B one C. And you can see that around half of that population had non insulin therapy and around half had basal insulin therapy alone. The baseline HB one C was 10.1%. And you can see on the right here that there was a significant improvement in HB one C, reducing from 10.1 to 8.6 with a minus 1.5% change in HB one C overall. But perhaps the largest real world study to report to date has been from the french group. A large retrospective study of over 74,000 patients with Type one or Type two diabetes from the french national claims database, looking at acute events such as DK severe high post coma etcetera. And for me what staggering here is, I think as I mentioned, we are very much convinced of the benefits of this technology in Type one. But actually what's surprising here is the benefits for acute events are very similar in the Type two population with a 52% reduction in DK, a 32% reduction in comas and a 39% reduction in acute events overall. Very similar to what we've seen in the type one population. And actually this is replicated again in the USA with rich bergen styles retrospective real world us study looking at the impact of flash glucose monitoring on acute events and hospitalizations this time in almost 2.5 1000 individuals a Type two on either short or rapid acting insulin therapy. They looked at the rate six months before and six months after flash glucose monitoring. And again we see significant improvements for both cute events and hospitalizations. So we very much hold the randomized control trial as a gold standard in terms of quality of evidence. But I would argue that the real world data really adds some detail there, particularly around the acute events. And we can see at the right hand side here that there is this emerging story around a reduction in acute events associated with flash glucose monitoring as well as consistent messaging around improvements in HB one C. And actually in the UK we have very recently had recommendations from Nice that we should be offering flash glucose monitoring to people with type two diabetes on multiple daily injections if they have recurrent hippos or severe hypoglycemia impaired hypo awareness or a condition or disability which the limits their ability to do blood glucose monitoring or if they're monitoring at least eight times a day. So we're seeing increasing access to flash glucose monitoring in the Type two population. But I also want to share with you some of the emerging evidence for flash glucose monitoring in type two diabetes. This is an interim analysis that was presented earlier this year. So I'll share some of the early insights from the immediate randomized controlled trial. This is a randomized control trial studying adults with type two diabetes who have inadequate control with non insulin. Anti hypoglycemic therapy comparing flash with an education with education alone for 16 weeks. Now interestingly their primary outcome is time and range assessed by blended C. G. M. And this is an interim analysis for the 1st 82 participants enrolled in the study. Now, if you glance down the right hand side here, we can see that we are already reaching statistical significance here for time and range with also significant improvements for time above range. So the early messaging from the immediate randomized control trial is that flash glucose monitoring Plus education is leading to greater time and range lower time above range and glucose monitoring satisfaction scores were also improved in the flash glucose monitoring and education arm only reduction H. B. L. And C also has been greater in the flash glucose monitoring arm with a minus 0.9% reduction compared to 4.5% in the education alone. So overall in the interim analysis of immediate flash glucose monitoring, users with type two diabetes using non insulin therapies had significantly greater time and range satisfaction of glucose monitoring and a greater reduction in. And I very much look forward to seeing the final results when they are announced. So we have considered the evidence for flash glucose monitoring. But I felt it would be important to share some of the wider emerging evidence around real time CGM in the population with type two diabetes. In 2017, Beck and colleagues published the diamond randomized control trial, which aimed to determine the effectiveness of decks. Com real time CGM and adults with Type two diabetes. These were adults with treated with multiple daily injections of insulin randomized to real time. See GM or usual care with the primary outcome of HB one C. At 24 weeks overall mean HB one C reduced to 7.7% in the C. G. M. Group and 8% in the control group with an adjusted HB one C difference of 10.3%. Building the evidence base to support the use of C. G. M. And adults with Type two diabetes. Moving on to 2021 martins and colleagues have published the mobile study. Now this is a study again of the decks. Com real time. See GM and people with Type two diabetes but this time treated with basil insulin alone without Crandall insulin. And this is a study delivered in a primary care setting. They did randomization with a 2 to 1 allocation of two C G. M versus blood glucose monitoring with a primary outcome of HB one C at eight months. What you can see here if you glance at the left is that overall in the Cdn group HB one C improved from 9.1 to 8% and in the control group from 9% to 8.4% delivering an HBO and see adjusted difference of minus 0.4%. They also report improved time and range in the CGM group 59% compared to 43% giving an adjusted difference of 15%. And there is also improvements in hyperglycemia, 11% in the intervention arm compared to 27% with an adjusted difference. So, building the evidence to support real time. See GM in type two diabetes. This time in those treated with basil insulin only. So going back to where we started, I think the transition from your into blood glucose monitoring was a challenge. And we have been arguing the case for improved access to real time CGM and flash glucose monitoring for people living with type one and type two diabetes. And I hope that the evidence that I've shared today gives you some insight into where we are in terms of the evidence base. But reflecting back on that analogy at the beginning, actually beyond the evidence as is fundamentally the right thing in supporting people to understand their glucose and change their decision making about their therapies and their behaviors going forward. So chair ladies and gentlemen, I think I've shown there is robust evidence to support flash glucose monitoring and type one diabetes, as reflected in the recent nice guidance. And we also now have growing evidence from both observational and randomized control trials to support the use of flash glucose monitoring and real time CGM and people living with Type two diabetes. But actually in my clinical practice, it's more about how you use that data to support people to make the most of their life with diabetes. And I'm very much looking forward to hearing from Ramsey A john, my friend and colleague from the UK who is going to be thinking about how we use this data beyond H B O and C. So thank you very much
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