Hello everyone. Welcome to the uh this session uh about session during the EISD uh 2024 CGM is an essential companion across the full spectrum of diabetes care. So I will deliver my talk which is uh uh which you will see in a minute. So it's applying CGM to improve glycemic control with automatic insulin delivery system in persons with type one diabetes. My name is Javier Uria. I am endocrinologist working in the Clinical University Hospital in Valencia here in Spain. Welcome to everyone to this fantastic symposium. So this is my disclosure as you can see here. So the question here is as you know, and these are data from the US from two important data base, the T one exchange and also the T PC O. And you can see that many people with Taiwan diabetes in the US are not able to achieve a good glycemic control. So approximately 20% of people uh o of the people achieve and Emily one see less than 7%. As you can see he even younger people are worse glycemic control and this is also associated with an increased risk of severe hypoglycemia. And also diabetic ketoacidosis. The situation in Spain is not different. These are data from 2021 and uh according from different uh 75 different hospitals including adult and pediatric population. And as you can see here, only approximately the 30% of the people with type one diabetes are able to achieve a one c less than 7% even in the use of ce M uh continuous glucose monitoring system. Then the question here is, well, for those people with bar glycemic control, we should be start first ce M or uh continuous subcutaneous insulin infusion. Then I will review with you the importance of the use of CE M as a need for optimal automatic insulin, the libra system. And finally, we uh will ask about what do to do what uh for overcoming the barriers to introduce automatic insulin system in our systems. So let me start first with the, the first question. So as you can see here in this slide in the last 50 years, there was a tremendous uh improvement in technology applied for diabetes. So uh at the beginning of the seventies, as you can see, we, we used the first uh uh home continuous uh home blood glucose monitoring system and also at the end of the 70 the first insulin pump and then in the, in the, in the la in the, in this century, at the beginning of the, on the 2000. So we became the first uh CGM system and most recently, uh as you can see here. So in the last uh 34 years, automatic insulin delivery system are, you know, making available a change completely the whole spectrum uh for people with type one diabetes. Now, we are done speaking only about uh Moe one C which should be as you know, less than 7%. We're speaking about all the important uh aspects regarding glycemic control as glycemic variability and also reducing and avoiding hypoglycemia and also particularly increasing time and range, which is the time as you know, between 7100 mg per deciliter. So now we have recommendations for different population regarding time and range time above range and time below range. And as you can see here, there is recommendation, different recommendation for people with type one, type two also for uh older people for pregnancy, et cetera. So now, uh also we can also compare and, and assume that approximately a timing range of 70% is uh related to an MOENC about 7% and which is with uh any increment or decrement in timing range by 10%. You will see approximately um a reduce or increase uh of Moe One C about 0.50 0.6%. In addition, beck and call uh also analyzed the data from the DC CT according to the, the the ranges defined by timing range, et cetera. As you can see here, they found they found that by each percent increase in in timing range regarding the use of uh home blood glucose monitoring, which uh we're using during this study, you will see or you will expect a reduction in micro women ria by twe 40% and a reduction in retinopathy by 64%. In addition, uh CE M has been demonstrated also to be very helpful uh for people with multiple daily injections and also for people with a continuous continous insulin uh infusion. And as you can see here for the different trials, the gold, the type on the control, the hypo and the impact. You will see that uh with a different moe one C at entry, you see with the use of CE ma decrease in uh glycemic variability and also a decrease in the time in hypoglycemia. So uh certainly CGM is uh really a very important. And now the question is for those people using multiple daily injection and maybe combat could cause monitoring. What should we start first? Should we start first with uh continuous subcutaneous insulin infusion or with uh uh uh uh CGM? And certainly we have the answer for this question. So we have the commissary study. Commissary study was a non randomized study uh in which people Taiwan, uh people with type one diabetes. What started uh as you can see here uh either multiple daily injections or continuous su cutaneous insulin infusion in combination with uh a home blood glucose monitor or AC GM. And as you can see here in blue, those uh groups either treated with multiple injection of CE I I, you will see that the use of CE M in combination, it is a major reduction over three years in moe one C. When you analyze also time and range and time uh below range, you will see that the, the effect of the use of CE M in combination with the two treatment insulin modalities, the improvement in time and range and the decrease in time below range was completely similar in in another study. This is a meta analysis comparing also the relative effects of AC GI I comparing um with to to multiple daily injections or CGM as compared to SMBE. And as you can see here, uh in both cases, the magnitude of the reduction of me mo one C was very similar with the in the two comparisons. But uh if you are thinking about uh uh glycemic variability, so measured by the standard deviation of glucose or uh the risk of severe hypoglycemia, you will see that the use of CGM was superior uh in terms of a major effect in reducing glycemic variability and also severe hypoglycemia. Well, what is the, the, the the importance of CD M uh for, for uh developing automatic insulin delivery systems? So as you can see, you know, uh the aim of the the insulin treatment for people with type one diabetes also is try to reproduce as much as possible the physiological insulin secretion. So replying uh the basal insulin need and also the pandal insulin needs. But this can also be achieved uh uh you know, with a combination of a Glucosure and insulin pumps uh also regulated by uh a particular control algorithm. This is the, the what we know the closed loop systems and this is uh the, the way we are moving. Um And, and, and you will see in, in, in, in this studies, it was a very small study, people using uh uh continuous subcutaneous insulin infusion uh with um with CD M. Uh And, and there were, you know, 40 people age, 52 years old and an Moe one C at entry uh equal or higher than 7.5%. Um The meaning of the study was to design if these people were randomized during 4014 weeks to an automatic insulin insulin delivery system, if this will be uh also or not associated with an improved glycemic control. And as you can see here, after 14 weeks, people using ID system increased uh uh uh timing rate by approximately 19%. And also there was a decrease in Moe one C at about 0.9%. But for those people using usual care that was also switched after four weeks to the automatic insulin uh delivery system to see that at the end of the trial, uh uh at 28 weeks. Uh the, the, the improvement in Moe One C and also time and which was completely comparable between the two groups. So that means that the uh a automatic insulin system improve even uh Mroe One C for those people using insulin pumps in combinations but not um uh regulated with uh CGM. This is also an observational study from the Steno Diabetes Center in which, as you can see here, it was uh over more than 3000 people using uh multiple daily injection insulin pumps, uh integrated or not with uh uh a glucose sensor and also people using automatic insulin resistant. The, the aim of the study was to evaluate the timing range, which was the timing range as compared with different uh insulin modalities. And as you can see here, those people using uh an I ID system are those who have the higher timing range and also the lower uh time below range. So that means that the uh this treatment is seems to be much more safe and effective as compared to other uh treatment uh modalities. As you can see here also from this study, those people with the ID system, uh there is an increase in time and range, also a decrease in time above range and also a decrease in time below range. Currently in Europe and the US there are at least five different uh hybrid system or ID system. We have the Kaps FX, we have also the di loop Metronic 620 G and, and 780 G, the Omnipod five and also the tandem control IQ in Spain, we don't have uh unfortunately, Omnipod five, we, we expect to have in, in the future where we don't have OMNIPOD uh five. And as you can see here for the, for, for the data and this, this, you know, from the three quarters on the last year, as you will see, uh it is estimated that approximately now there is a approx uh 11.1 million users of ID system in which as you can see here, Metronic is the the most used system, but you see an increment for all of them also for uh insolent omnipod five and also for tandem control IQ what about the benefits of this um systems? So this is uh uh meta analysis uh including 22 randomized control trials um which also include people, adult people and Children population with Taiwan diabetes. The main um uh objectives of, of this metasis, the primary outcome was to evaluate the timing range of the system and people were using the system at least three months. And you can see here there was an an increase in timing range uh associated uh with a decrease in moe one C uh also a decrease in time be beyond range without we felt a significant increase in in, in DK A or severe hypoglycemia. And more importantly, for the first time. Uh In this study, it was also shown a red a reduce in diabetes related distress, which is also, I'm in my opinion, also very important data from the UK. And this is an, an pragmatic observational study uh starting uh some uh so a couple of months uh uh ago, including people with insulin pumps and, and uh and continuous uh multiple uh continuous glucose monitoring uh system. Uh These peoples were um uh included, they have a baseline mo UN C had an higher than 8.5 per percent. In fact, the main baseline was 9.5%. And, and as you can see here that these people were starting an an automatic insulin system in 31 centers. And the amount of basing included in the study was more than 500. So the, the uh the outcomes of the study was uh uh to, to look into MOE one CGM I other uh uh glycemic parameters, but also, you know, uh diabetes stress goal score, et cetera. And as you can see here now, the main results. So for those people starting with a baseline of 9.4%. Uh after am of six months, there was a decrease of 1.7 in moo one C and, and similarly, there was an increase in time range for 34 to almost uh 62%. And importantly, it was also a decrease in the diabetes stress scale as you can see here uh which means also that people using this system also improve uh his quality or the quality of life. In addition, I want to show you a study making Spain for the uh um um applied group. Uh the the group of a uh applied technology for diabetes from the Spanish Diabetes Society in which uh 14 sectors are participating. Um 100 people were randomized to evaluate or to compare uh the benefits of starting uh uh Metronic se 708 A TG or the tending control IQ the people were followed during three months. And the primary account was to see to look into the change in timing range. As you can see here, both system uh increased similarly, the, the timing rate by approximately 40% with a decrease in moe one C but also other uh aspects were evaluated in the study. And particularly it was shown uh also as a decrease in diabetes restricts distress and improve in sleep quality. And also using another um uh mm uh questionnaires. We also uh evaluated the expectation of the people and, and the majority of the people included uh in the study. Uh They said that the, the, the, the this system exceed the expectation for them. Well, let me go now to com uh a real uh uh clinical case from my practice and, and I want to uh to present to you Clara Clara is a, a 33 year old female who has uh type one diabetes from 15 years with no chronic complication. As you can see here. And this is not usual in spain, I would say uh five gestation with four deliveries and one abortion. Um despite of this, she wanted to be pregnant again. So uh this patient was treated with multiple a injection. I will show you in a minute. And also uh she was using a freestyle libre too. The patient was uh had an optimal diabetes education and was very compliant with the treatment. Uh the people, people with uh treating with guarding U 300 lice pro preprandial. She was able also to carbohydrate counting. So, and as you can see here, uh uh GM I was 7.5 and, and timing range using this treatment was 77%. Despite of this, this patient had uh you know, a time below range as you can see of, of uh 9% altogether. So patient was uh have frequent co co corrections uh after the meals. Also, she dislikes to have hyperglycemia. And also she showed as you can see here mild uh uh uh epo glycemia episodes during the night. And she said to me, so if I want to be pregnant, I I don't want to spend too much time killing on my diabetes. And I don't want to have another pregnancy with multiple daily injections. Therefore, we um recommend um her to start an automatic insulin delivery system. In 20 May 2022 she started a Metronic 7 7700 AD G. And as you can see here, and luckily six weeks later she became pregnant. So, uh here you can see the data uh for uh in September 12 of September. And as you can see here, a very flat glycemic profile. So GM I was at this moment uh of si uh 6.4% with a very low glycemic uh uh variability coefficient of variation. As you can see here, the timing range was uh 88% at the end of the pregnancy. Uh She said also during the pregnancy, I'm very happy and confident with this system. Uh uh mm later on the pregnancy, uh there was obviously an ongoing optimization of glycemic control. As you can see here, uh timing range even improve more to 92% with very low glycemic variability. And also, as you can see here with a wonderful uh glycemic profile with a very low uh insulin auto correction. So excellent glycemic control at the end of the pregnancy. Uh uh the vi uh the delivery was vaginal at 39 weeks without problems. Uh The system adapted automatically to, to reduce insulin uh needs after delivery and and also patients started to breastfeeding. Although she she demonstrates some mild hypoglycemia that needs obviously uh real attention of the carbohydrate. Retro importantly, uh 24 2 ye two years later, after starting the system and also after delivery. So in May 2024 MRE One C is still very, very good. Uh, it was uh 6.4%. So, uh this is a case in which uh an automatic insulin system improved a lot. Uh, the glycemic control and also reduced the uh uh distress associated to control of diabetes. And the patient was really very happy. Well, how can we overcome uh the barriers to introduce automatic insulin system in uh in, in, in our um um uh hospital in, in our country, et cetera. So let me start first with uh some of the recent nice recommendations to access uh to automatic insulin delivery system for people with type one diabetes. So in the UK, it's recommended by the nice uh for those people with uh uh um one C uh equal or, or higher than 7.5%. For those with disabling hypoglycemia also is recommended as an option for those uh women who are pregnant or planning to be uh to be pregnant. And also for people which I uh with, for Children and, and young people with, with not good glycemic control in Spain. Recently, also uh from the Health Minister and also the, the um the agency for for evaluating uh different uh technologies. So uh it becomes the uh uh some recommendation also conditional in favor of the ID system in Spain. And these are for people with poor g glycemic control um is not defined exactly uh at, at what level of mo A one C and also for those people at risk for hypoglycemia, including adults and pediatric population. Also an as an option is recommended for, for uh women uh who are pregnant or planning to be pregnant. And also it is al also, um uh at the end of the conclusions, uh this agency uh said that the ID system has also a positive risk benefit balance. Well, what we need is still to more widespread use of ID A system, certainly we need more uh centers, more symptoms with know how we need also a beta training material as both for healthcare professionals and patients. The most important I from my opinion, we, we need also lower price uh of the systems and that this is not as simple as possible with free alarms to avoid alarm, fatigue. And and finally, also probably we need to be focused as I mentioned before in more of the psychosocial benefits of the ID system in the patients. Now, uh we will have in the future different uh uh and, and I hope much more uh uh hybrid closed systems uh with more evidences, more with more, more license with uh also beta sensors with the smaller size, with high accuracy and also with, with improving pals with in terms of size and interface, et cetera that that probably the future may be available that, that all the system can be combined. So ca can be combined um uh um CGM system for, for one brand to, to two pumps for another brand, et cetera. And this is exactly what is uh occurring with, with uh uh the new combination of the Freestyle Libre three and the Fiesta Libre two plus. And you can see here. Freestyle Libre three can be also be used with the can apps in combination with uh Epsom E and also the freestyle uh two plus can be used with, with the tandem and also with the Omnipod five. To conclude, I would say that ce M should be considered in any case first before uh insulin pumps that ID A system will improve Mru One C A glucose metrics as well as psychological out in people with type one diabetes. Now, we have several ID system using different algorithms and glucose sensor. But you know the the outcome is very similar across the the systems. New technologies obviously are costly and we know to overcome the barriers to facilitate the access of people who have the diabetes to the system. And finally, I will mention that also the freestyle Libre two plus and the Friess libert three is also now a part of the new ID system. Thank you very much for your attention.
Related Presenters
