Video Prospective Observational Studies Evaluating Glycemic Metrics in Persons with Type 2 Diabetes Play Pause Volume Quality 720P 720P 576P Fullscreen Captions Transcript Chapters Slides Prospective Observational Studies Evaluating Glycemic Metrics in Persons with Type 2 Diabetes Overview CONTINUE TO TEST Back to Symposium Thank you very much protect for this very kind introduction. Um Dear colleagues. Um my name um as you've already heard this Monica Calera. I'm an endocrinologist and the pathologist. And my medical director at the Saint Mary Hospital is to get Germany. And the topic of my talk today is studies evaluating glycemic metrics with flash glucose monitoring in persons with type two diabetes. So these are my disclosures I'd like to present here and then um Dia colleagues as we all know um diabetes is a worldwide and globally growing disease um and diabetes is diagnosed and defined by high glucose levels as we all know. So diabetes comes along with some really um severe complications like increased cardiovascular disease, diabetic kidney disease, nerve and vascular damage and diabetic food complications as well as diabetic eye disease and some others um for minimizing or avoiding these complications. It's crucial that our patients are under optimized glucose management and most guidelines recommended for Type two diabetic patients and HB A one C goal being uh below 7.0%. However, as you can see here on this slide, only roughly about 50% of our patients with type two diabetes are on this goal. There's our data from us on the left side, but here on the right side you can also see Canadian datas. And in europe several european countries. We can also see that only about 60% of our patients with type two diabetes achieve an HBO one sea level below 7.0%. So we have to have a better treatment for these patients. But I think in addition we also need better glucose monitoring options for diabetes management and a sense of based C. G. M. Is clearly such an option to get the maximum benefit out of this sensor based C. G. M. Systems which can be one of our patients um and a T. T. T. Consensus group published recommendations in the year 2090 and they recommended that the falling parameters should be available to assess. She see GM data's first data should be analysed from um approximately 14 days um of A C. G. M. Being born Then um the CG. M should be at least active 70% of the time mean glucose levels as well as glucose management indicator should be available. And also time in range which is defined as glucose levels between 70 and 180 mg per decile later. In addition, time below range and time, a buff range should also be available. And um this group also recommended use of ambulatory glucose profile for C. G. M. Report. Ambulatory Clucas profile and show you an example of an H. G. P. Report here. Ambulatory Lucas profile can serve as a template for representation and visualization of C. G. M. Derived data. So uh in in the GDP report, um the core C G. M data are shown um for example here, beginning on the left upper side, it indicates how many days the c g. M system have been born. It indicates how long um the C G. M system have been active during this time. Um It shows also average glucose levels or and glucose management indicator, which is estimated HBO one C during this timeframe. And it also shows glucose variability on the right side. We can see um glucose ranges. So how many of the time patients have been in the target range or below or above the target range here in the middle, a composite um glucose profile of 14 days or maybe 10 or 12 days. How long the C. G. M has been worn is shown also with the variation as you can see. And the ambulatory glucose profile provides also the day today um glucose profiles which is shown in the example here on the bottom. So I think ambulatory glucose profile um report really um is a very structural arised um report of poor C. G. M. Data and it really helps a lot in in discussing all the C. G. M. Datas with our patients. And it also has for clinical decision making. Now. The A. T. T. T. Consensus group also gave guidance on targets for assessment of um glycemic C. G. M. Data and they recommended for type one and type two diabetic patients. That timing range which can be derived from C. G. M. Data, that the patient should be at least 70% of time in the range of 70 to 100 mg. Um Desolate to um glucose. And the time below The range of less than 70 mg should be north, not more than 4-5%. And the time spent above the range should be not more than 30%. Yeah. Some uh tighter targets, for example here on the very right side for women with gestational diabetes and there are less ambitious targets, for example here in older people or do with high risk. Now that's a data from two meta analysis um showing the relationship between time and range and HB A one C and what both um data already our analysis um really showed us that there is a really a relationship between time and range and H. P. M one C. So having time and range of about 70% translates um into an HB A one C levels of 7.0%. Or in the other studies. Type two diabetic trials have been included. It translates into an HB. C Into 6.7%. And interesting also every 10% increase in timing range um trans uh first into an H. B. F one C. Reduction between 0.5 Um to steal their .8%. So also the data are not exactly the same because different trials have been analyzed I think. Um this publication really shows that timing range um really correlates with HB A one C levels and also changes of HBO one C levels. So let's now move to some Retrospective as well as randomized control studies uh in type two diabetic patients using a flash glucose monitoring system. The first study I'd like to share with you as a retrospective observation and analysis from two chairman diabetes centres patients. Um what type two diabetes have been studied? Um Some baseline characteristics you can see here mean age was 62 years duration of diabetes 14 years. Baseline H. B. F one C. Was 7.7%. And all patients have been on multiple daily insulin injections. Now at baseline patient received uh flash glucose monitoring system and varying glucose monitoring system. You can see that um the HBO one C Dropth down from 7.7 to approximately 7.1%. Which can be seen here in the flesh glucose monitoring group with orange bars. And that was significantly different to the SNB G. Group which can seen here in the blue bars. So using a flash glucose monitoring system um was accompanied with significant reduction of HB. A. One C. That's another um retrospective real world chart ref you from three european countries namely Austria Germany and France. And again adults with Type two diabetes being on baseball's insulin have been analysed after six months use of a flash glucose monitoring. We can see a change in HB A one c of 10 million more per mole. Which approximately is about a reduction of 1% in H. B. O. N. C. And the data are very consistent uh in all three countries, as you can also see here on the slide. Um uh This is a sub group analysis from the same publication and it basically shows that when baseline HB A one C was higher. Uh Those patients on flash glucose monitoring systems show even more reduction of HB A one C. Otherwise being younger and older, male or female being um longer or shorter duration on insulin or having higher or lower HB A one C. All these subgroups benefit with the same Um HBO one C reduction as you can see here. That's another sub analysis from the french population of this study um evaluating whether the method of insulin administration has any influence in flesh glucose monitoring wearing patients. And you can see here patients with multiple daily insulin injection um had an HBO one C reduction um of uh 0.7% six months after initiating of flesh glucose monitoring system. And pump uses. You can see even have more of HBO one C reduction. That was 1% reduction. So pump uses may probably even benefit more from such a C. G. M. System on the bottom here. You see exactly the same result but given here millie mall so I won't repeat this um here. So let's now show a few randomized control studies in type two diabetic patients um using flash glucose monitoring system. This is a multi center open label randomized control trial um from 26 different european diabetes centres. It's um already a little bit older study. And um the intervention in the intervention group, S NBCI has been replaced by flesh glucose monitoring system and six months after patients have been um compared in between flesh glucose monitoring system and sMB key. And what we can see here on the left side first is that mean glucose was um similar in both groups. However, the flesh glucose monitoring um group had significantly less time in hyperglycemia. So they had reduced hyper glycemic rates. And on the right side you can also see that wearing a flesh Lucas monitoring system goes along with a higher rate of treatment satisfy occassion. Um So treatment satis fication score was significantly better compared to the control group with S. NBCI Here. I'd like to show you another randomized control study um in type two diabetic patients using a flash glucose monitoring system. That's a very interesting study from Japan. I think it's very interesting because Type two diabetic patients in this case without insulin have been studied and that's actually the largest group in Type two diabetics. Um I'd just like to make you familiar with the study design. Um patients have been randomized into an intervention group using a flesh glucose monitoring system which was unmasked so the patient could see their values and react and the control group using a conventional SMP key. Before randomization patients had a blinded F. G. M. For 1 to 2 weeks. And the control group also had a blinded F. G. M. From week 10 to 12. Primary outcome was changed in HBO one sick at week 12 and week 20 for um maybe a few baseline characteristics. First, before I show you the results from this study, the age of type two diabetic patients was 58 years. Um mean body mass index in this asian population was 27 kg per square meter. And baseline HB A one C was 7.8%. This are the primary outcome change in HB A one C. And we can see the intervention group using flash glucose monitoring system here in the solid line and um the control group in the dash line. And what we can see is that um HB A one C. Was lower after 12 weeks and also significantly lower after 24 weeks in Type two diabetic patients using a flash glucose monitoring system. And there are some more classes. Emmick outcomes from this trial. Um showing that um the intervention group with the flash glucose monitoring system um spent more time in range. Um Compared to the control group with S. M. BG, which was clinical statistical significant and also time in hyperglycemia was significantly less in the patient group wearing a flesh glucose monitoring system. And that was true actually for all categories. So for venues above 180 above 240 above 300 mg per deciliter. Um All has been statistical significant. Um Compared to um S. Mpg group treatment satisfy occassion overall was higher in the uh flesh glucose monitoring varying group especially um convenience and flexibility has been hate rated high. And that was all statistical significant difference compared to the S. M. Bt group. So um let's show um uh some more data um uh from real world evidence which I think are in some way interesting. That's a very recently published um work from Right and colleagues. And I think that's an interesting um um study because type two diabetic patients have been studied who are under very poor who have been under very poor control with a basil, H. B. L. And Z. Of at least 8% or above. Um after initiation of flesh glucose monitoring system. HBO one sea change has been evaluated six months after the patients have been categorized into three baseline HBO one C group. The first group having a baseline HB A one C between eight and 10% showed a drop in Hb A one C of 0.44%. The group with in baseline HB A one C of 10 to 12% showed a drop of uh the H. B. L. One C. Of 81.8%. And the highest baseline HB A one C group which was above 12% showed a really very impressive hB a one C reduction um uh with six months during a flash glucose system um of minus 3.5% here. We can see um whether there are any differences in patients with being on insulin, on those being not on insulin. Um Type two diabetic patients on insulin in general showed an HB A one C reduction of almost 1% after this six month period. Non insulin users even had a better outcome with an H. B. F one C reduction of minus 1.5% In total, all patients, all HB A one C group showed a really impressive HB A one C reduction which is shown here on the very right side of minus 1.38%. So this study clearly shows um in patients having higher baseline HB A one C. Um They may even benefit more by um more reduction of HB A one C. Um when using flash glucose monitoring system. Now. At this year's 80TD meeting to interesting um studies with flash glucose monitoring in type two diabetes are also presented um from Italy and one from Canada. This is um the data from Italy. It's prospective observational study. Um 322 patients with Type two diabetes and being on bass lamb bolas, insulin have been a road from 16 hospital sizes besides HB A one C. was evaluated 3-6 months after initiation of a flesh glucose monitoring system and was compared to an smb key group. The results after 3 to 6 months 230 for complete case patients demonstrated significant reduction of HB A one C. For freestyle liberal users compared to smb. G. By 0.3%. So in conclusion, this real world prospective cohort study concludes that people with Type two diabetes on base bowlers, insulin using a freestyle liberal for 3 to 6 months significantly reduced the H. P. M one C. Compared to the S. And P. T. Group. Now, this is also data presented at this year's 80 D. D. Meeting from Canada. It's a retrospective real world chart ref you study from Canada in this case, type two diabetic patients using only basil insulin regiment have been analyzed and um changing HB A one C have been analyzed 3 to 6 months after initiating flash glucose monitoring system. In this group, Baseline HB A one c. 8.9%. And here are the results after at least three months of using a freestyle libre system. HB A one C. Was significantly reduced by 0.8%. The subgroup within baseline HBO one C of less than 9% showed a reduction of 0.5% in H P. L one C. Um And the subgroup within baseline HP. F one C above or equal to 9% shows a very impressive HP. F one C reduction of 1.6% as you can see here. So include conclusion this real world retrospective chart refuge study um What type two diabetic patients being only on basal insulin and using a freestyle liberal system for between 3 to 6 months. They had a significant reduction in H. P. M one C. Now let's go a little bit beyond HBO HB A one C levels and glycemic metrics. I think that also was a very interesting study published by Erhardt and cigar in the last year in 2020 and they try to evaluate whether continuous glucose monitoring can serve as a behavior modification tool. I think that's a very interesting question. They decide an 18 item questionnaire and current C. G. M. Uses with any type of diabetes have been interviewed to determine their perceptions of how see G. M. Affects their nutritional and their physical activity choices. And here you can see the answers. 19% of CG. M. uses felt that it's used contributed to a healthier lifestyle. 47% of CG. M uses reported being more likely to go for a book or do physical activity if they saw a rise in the glucose levels, 87% of C G. M. Users felt that they modified the food choices based on C G. M. Data. So I think this is a very interesting pilot study and clearly more research is needed into C. G. M. As a behavior modification tool for diet or exercise in individuals with diabetes or even in pre diabetic patients or pre diabetic population. Now, I think in clinically important question is how can the use of continuous glucose monitoring difference fruit into clinical meaningful outcomes? I have shown you retrospective real world evidence as well. A data from randomized control studies in Type two diabetic patients using flash glucose monitoring system showing that HBO wants sea levels going down, showing that time and range increased. And also um Time in hyperglycemia and hyperglycemia was less so interestingly that um um just recently published from a group in china, they showed um the relation of time in range to all course um and cardiovascular mortality in patients with Type two diabetes. So time and range is um um derived from C. G. M. Data and they categorized um there um study group into four time in range groups. One in red was the one with the lowest time and range below equal to 50%. Um And the green group was uh with the highest rate of time in range, which was above 85% in range, which means glucose levels between 70 to 180 mg. And what we can see here on this slide is that the group with the lowest time in range rate had the worst outcome. And the group with the highest time in range rate had the most favorable outcome in terms of all cause mortality here on the left side. And the same could be seen here also in terms of cardiovascular mortality, patients with the highest rate of timing range had the most favorable outcome. So I think timing range, which is derived from C. T. M. Data is clearly a meaningful perimeter which correlates with relevant clinical outcome. And um uh in the same direction I would say is um this uh study by Bergen style and colleagues just recently published And they have shown that Flesh CTM is associated with reduced diabetes events and hospitalization in insulin treated type two diabetic patients. This was a retrospective database study and um They had a cohort of 2,463 type two diabetic patients being on short acting insulin. And here on the left side you can see um the graph where they analyzed patients before using six months period before using um flesh glucose monitoring system. This is the um solid dark line here and the red dash line here shows the same cohort um during a time frame of six months after initiating flash glucose monitoring. So what we can see on this graph is that when starting to use flash glucose monitoring system, the acute diabetes event rate goes significantly down the relative risk production compared to the time period before Um the flash glucose monitoring system was initiated was um really a very impressive risk reduction of 61%. And the same can be seen here on the right side page when patients start to use a flash glucose monitoring system, they had significantly less or cross inpatient hospitalization compared to the six months period before they use um such a flash glucose monitoring system and again the relative risk reduction of 32% was highly statistically significant as you can see here. So I think this data, which have been recently published clearly show that varying flesh glucose monitoring system in patients with type two diabetes um correlates with more favorable clinical outcome in this patient group. To summarize, as I have shown you in the beginning manage to diabetic patients do not achieve their close emmick goals. Flash glucose monitoring replaced sMB. T. and results in significant and persistent H. B. F one C reduction less hypoglycemia. More time in range and higher treatment satisfy occassion in Type two diabetic patients with and without insulin. More time in range, coral correlates with less or cost and cardiovascular mortality. As previously published from uh this study in china, I have shown you and see GM may also serve as a modification tool for healthier behavior. And just the last slide I have shown you flesh. C. G. M. Is associated With significantly less acute diabetes events and hospitalization in type two diabetic patients. So in general, I think um these studies really suggest that continuous glucose monitoring will be increasingly used in type two diabetic patients who do not reach their targets with this. I'd like to close and thank you very much for your attention. Published May 26, 2021 Created by Related Presenters Prof. Dr. med. Monika Kellerer President of the German Diabetes Society (DDG)Medical Director Center for Internal Medicine I Marienhospital StuttgartStuttgart, Germany
