Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES

For diabetes care and education specialists, late April and early May have ushered in a whirlwind of knowledge and advances. ATTD 2022 marked the start of a conference season that includes meetings hosted by the American Association of Clinical Endocrinology (AACE), the American Diabetes Association (ADA), and the Endocrine Society within a 48-day span. Add to this, news surrounding the US FDA’s 

approval of Eli Lilly and Company’s novel dual GIP/GLP-1 receptor agonist

, tirzepatide, and the full docket of news and information to download from this brief period becomes clear.

In this episode of Diabetes Dialogue: Therapeutics, Technology, & Real-World Perspectives, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, take a deep dive into the tirzepatide approval, including discussions around the mechanism of action for the first-in-class agent, dose titrations, and where it might fit in the upcoming ADA standards of care. Later in the episode, hosts recap their experiences from 

, which saw the release of guidelines for diagnosis and management of nonalcoholic fatty liver disease (NAFLD) in primary care and endocrinology clinical settings.

previous episodes of Diabetes Dialogue: Therapeutics, Technology, & Real-World Perspectives

recap of the 15th International Conference on Advanced Technologies and Treatments for Diabetes.

Diabetes Dialogue: Therapeutics, Technology, & Real-World Perspectives is available in an audio-only format on 

Podcasts

In this episode of Diabetes Dialogue, hosts Drs. Isaacs and Bellini take a deep dive into the tirzepatide approval, including discussions around the mechanism of action, dose titrations, and where it might fit in the upcoming ADA standards of care. Later in the episode, hosts recap their experiences from AACE 2022, which saw the release of new guidelines for NAFLD.

Diabetes Dialogue: Tirzepatide in Action & AACE 2022 Recap

In this special edition episode of Diabetes Dialogue: Therapeutics, Technology, & Real-World Perspectives, hosts Diana Isaacs, BCPS, BC-ADM, BCACP, CDCES, FADCES, FCCP, and Natalie Bellini, DNP, FNP-BC, recap their experiences from the 15th International Conference on Advanced Technologies and Treatments for Diabetes (ATTD). 

Topics of discussion for the episode include favorite sessions from the conference and clinical pearls they took away from their experience, including the latest updates in the world of diabetes smartphone apps, smart insulin pens, and CGM systems. Also included in the episode is a reaction to Eli Lilly and Company’s announcement of topline data from the SURMOUNT-1 trial in late April.

Diabetes Dialogue: Therapeutics, Technology, and Real-World Perspectives is available in an audio-only format on 

In this special edition ATTD Recap episode of Diabetes Dialogue: Therapeutics, Technology, & Real-World Perspectives, hosts Drs. Diana Isaacs and Natalie Bellini provide insight from ATTD 2022, including the latest updates in the world of diabetes smartphone apps, smart insulin pens, and CGM systems. 

Diabetes Dialogue: ATTD 2022 Recap

Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES:

 Despite all of the amazing advancements that we have had in the CGM [continuous glucose monitor] space, there are still some unmet needs in research and clinical treatment. I do a lot of management in pregnancy, and we lack clinical studies in pregnant women with preexisting type 2 diabetes or true gestational diabetes, where women develop diabetes during their pregnancy. We just got a grant to study Dexcom in pregnant women with gestational diabetes. We need more information in this space. There was a randomized control trial done in women with type 1 diabetes and we have recommendations for the target range, which in pregnancy is 63 to 140 mg/dL, but we lack guidance outside of that for type 2 and gestational diabetes in pregnancy.

It would also be valuable to collect more information on the use of CGM and the outcomes in people with type 2 diabetes who aren’t taking insulin. There’s a bunch of research being done in this area that has shown some impressive reductions in A1C [glycated hemoglobin], but we lack strong randomized control trial data in this population. Last year, we had the MOBILE study, which studied type 2 diabetes on only basal insulin and showed an impressive A1C reduction in that population. I’d like to see more on the complete non-insulin users.

The other area where we need more research or best practices is the implementation of CGM. Many of us are sold on CGM being a great tool. It’s going to benefit our patients and the costs are coming down to make it more affordable for more people. However, how does a busy practice suddenly implement this tool? How do they download the devices? Who’s going to review it? How do they get their team up to speed on reviewing these reports that look different from typical glucose meter readings? We need more of that so we can efficiently get this into practices across the country and world.

As the landscape changes, my advice for people who are trying to use CGM to manage their patient population with diabetes is to just use it. Don’t be afraid of it. Because it’s here and it’s an excellent tool that’s likely going to become the standard of care. It already is becoming the standard of care, but I strongly believe that one day it’s just going to replace glucose meters, like how meters replaced urine.

The next step is to embrace it and learn about it and figure out how we can best adopt it and bring it to the practice. The best way to do that is to utilize and lean on members of the team. We understand that people in practice who are seeing patients every day are busy. I know because I see patients every day. That’s my primary role. I see so many people around me getting burned out because they’re asked to do more and more. There are more messages. You’re going to start getting patients messaging you saying, “I got this alert. What does this mean?” It’s important to have a plan in place for working with that.

Fortunately, there are a lot of people who want to be technology champions. When you think about the diabetes care and education specialist or the pharmacist, dietician, nurses, or your MAs [medical assistants], who on your team can you utilize who’s interested in this space and wants to develop more expertise that can help you? I’d encourage you to think about that and not think of this as 1 extra thing that feels like a huge burden, because it’s not. This will help you as long as you have a plan in place to implement it.

I want to thank you all so much for watching this 

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Dr Diana Isaacs provides insight on current challenges in the clinical treatment of patients with diabetes and shares clinical pearls for the use of CGMs in disease management.

Unmet Needs in Diabetes Management

 There’s a lot of excitement in the CGM [continuous glucose monitor] landscape. There are a number of companies working on less invasive CGM. All the current systems require it being a sensor that’s placed under the skin, but there’s interest in different types, like watches, that sit on the skin that would be a little less invasive. There are a lot of companies working on that that we’ll likely see in the upcoming years.

More in the near future is Freestyle Libre 3 System, which is available in Germany and some other places in Europe. Basically, it looks like the Freestyle Libre 2 System, only smaller. It’s the size of 2 pennies instead of 2 quarters, so it will be a bit tinier. The biggest difference with Libre 3 is that it will be real-time CGM. Libre 2 is what we consider intermittently scanned. You need to scan with a reader or smartphone to see the reading. It has real-time alarms that go off regardless of whether a person is scanning or not. But to see the reading, you have to scan. The Libre 3 will become more of a true real-time CGM where a person could look at it at any time and see their reading. We look forward to that coming in the future and seeing more data on that.

Medtronic has the Guardian 4, which is already available in Europe, but isn’t yet available in the United States. It’s similar to the Guardian 3 in a lot of ways. However, it won’t require calibrations. That will be a huge enhancement of the current sensor. They have another one that they plan to submit to the FDA after they hear back about Guardian 4 that’s more similar to the Libre and what we expect from Dexcom G7, in that it will be a fully disposable transmitter sensor combination and also wouldn’t require calibrations. There’s lots of excitement there.

There’s another thing I wanted to mention. Time in range is big. That’s the time spent between 70 and 180 mg/dL. There’s a big movement to use that to evaluate new medications and move away from an A1C [glycated hemoglobin]–centric diabetes culture. What I find interesting is there’s also time in tighter range, which is the time spent between 70 and 140 mg/dL. More studies are starting to look at this tighter range and compare differences. Especially when you think about people with prediabetes or are maybe at risk of diabetes, time in tighter range may be more informative. There’s a lot of excitement. The 2022 ATTD [International Conference on Advanced Technologies and Treatments for Diabetes] will be coming up at the end of April, and there should be a number of studies that report out and lots of exciting information.

Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES, evaluates upcoming CGM advances in the pipeline for the management of diabetes.

Future CGM Advancements for Diabetes Management

 I want to take a moment to talk about Eversense’s recent 180-day approval for their CGM [continuous glucose monitor] because this is remarkable. It’s the only device that’s an implantable sensor. The previous version was 90 days. It’s a quick in-office procedure to implant it, and then that sensor stays there. There’s an outer transmitter that is placed over it. Going to 180 days is remarkable because that means it cuts down on those office visits to only 2 times a year. This is an appealing option for many patients, because being able to reduce the process of having to insert the sensor is nice.

The other key thing is people like the option to be able to detach. When you’re wearing a CGM, with most of the others, you can’t take it on and off. Once you place the sensor, if you take it off, you have to put on a new sensor, which is an additional cost and an additional process of the warm-up period. It’s not practical to do that. But with Eversense, you can take it on and off, which is very appealing, especially for active people who want to have that flexibility. The other interesting thing about the Eversense 180-day wear is that it cuts down on the calibrations. With the 90-day, it’s basically a calibration every 12 hours. With the 180-day, it’s every 12 hours for the first 21 days and then once every 24 hours after that. Those are big enhancements. We’re going to see more people interested in the uptake based on these new enhancements with Eversense.

Speaking of new technology and CGMs, we also have the Dexcom G7 on the horizon. The clinical trial data were recently published on that showing the accuracy. One of the enhancements with it is the warm-up time. The current warm-up time with the Dexcom G6 is 2 hours, which isn’t bad. It just means you don’t see the readings for the first 2 hours of wear. But with the G7, it’s cut down to less than 30 minutes, which is going to be nice. The other thing is it’s smaller. It will be smaller than the current G6.

Perhaps the best enhancement of all is that it’s a fully disposable transmitter sensor. It’s more similar to what we’re used to with the Freestyle Libre 2 System, where it’s all a disposable system. When you’re done, you discard it and put a new one on. That’s how the G7 will be. There won’t be this additional transmitter that you have to save that you used for 3 months. All of that will be discarded and you will place a new one on. These enhancements will be very nice. I’d anticipate that when G7 becomes approved—it has been submitted to the FDA [Food and Drug Administration]—that it will likely end up replacing the current G6 system for the future.

Dr Diana Isaacs reviews the significance of Eversense’s recent approval for a 180-day indication and the potential role of Dexcom G7 in the diabetes treatment landscape.

Emerging CGM Systems in Diabetes Management

 When we think about CGM [continuous glucose monitor] accuracy, they’ve all shown that they’re pretty accurate. We have a term we use to describe the accuracy: mean absolute relative difference [MARD]. The lower, the better. According to the FDA, when MARD is below 10%, the device is accurate enough to base treatment decisions on. That would include treating hypoglycemia or determining insulin doses based on the numbers. We feel pretty comfortable with their accuracy. It continues to improve.

One thing we have to be aware of is that there’s a slight lag time with CGM. The gap is closing, so the lag time isn’t what it was like 10 years ago. But because fingersticks are measuring the capillary and CGM is measuring interstitial fluid, there’s a slight delay. That means that if somebody recently ate something, the glucose on the fingerstick might be a little higher than it would be on the CGM. Similarly, if someone recently exercised or recently gave an insulin injection, that number may be a little different. Educating people on those differences is very important.

Beyond that, calibration is sometimes a factor that goes into device selection. When you calibrate, you’re essentially doing a fingerstick and entering the result into the device to calibrate it. Any time you do that, you could be entering in some error, because we know fingersticks aren’t perfect. If you have anything sticky or sweet on your fingers, or if you didn’t get a good enough sample, that can skew the reading. If you put a bad reading into the device, you’re probably going to skew the accuracy. That can be a determination. Devices that are factory calibrated are often preferred because you have less interference, and it’s easier for the person because they don’t have to do additional fingersticks.

CGMs have evolved so much over the last several years. It has been amazing. Some big advancements are regarding calibrations. It used to be standard that all CGMs required fingersticks, and now we have factory-calibrated options that don’t require any fingersticks or have them as optional. There have also been impressive advancements with wear time. One of our devices goes up to 14 days. Another is implantable and goes up to 180 days. Wear time has evolved. It used to be about 3 days to start.

The other area where we’ve seen a lot of advancement is with integration. We have CGMs that integrate with insulin pumps to have automated insulin delivery, which is incredible. We also have CGM integration with connected insulin pens, which can also use those data and be able to view it in 1 report, which is remarkable. Several mobile apps can link in with these CGM data. Accuracy has improved a lot over the years, and we’re seeing that the sensor is getting smaller. They used to be much larger, and now you barely notice it and barely feel it. There have been lots of great positive enhancements over the years.

Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES, comments on the accuracy and selection of CGMs in treating diabetes and shares insight on the evolution of CGM systems over the past year.