In part 2 of this 2-part podcast, Mary Caffrey, associate editorial director of The American Journal of Managed Care®, speaks to Greg Forlenza, MD, a pediatric endocrinologist, about prepivotal data.
This podcast is brought to you by Insulet.
Today we are bringing you part 2 of a 2-part, sponsored podcast series discussing insulin delivery for patients with diabetes. In part 1, Mary Caffrey, associate editorial director of The American Journal of Managed Care® (AJMC®), spoke with Greg Forlenza, MD, a pediatric endocrinologist at the Barbara Davis Center at the University of Colorado, about prepivotal data. In this segment, they conclude the conversation.
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MARY CAFFREY: Welcome to the AJMC® podcast Advancements in Automated Insulin Delivery. I’m Mary Caffrey, associate editorial director for The American Journal of Managed Care®. This second of 2 segments features exciting prepivotal data for the Omnipod 5 (OP5), an important development in diabetes care coming in 2021. We also discuss issues with payer coverage and the current focus on disparities in access to diabetes technology. Joining me is Dr Greg Forlenza [MD], a pediatric endocrinologist at the Barbara Davis Center for Childhood Diabetes at the University of Colorado. In this segment, Dr Forlenza will discuss the prepivotal data. Today’s podcast is brought to you by Insulet.
Welcome, Dr Forlenza.
There was recently some prepivotal data involving the Omnipod 5.Can you tell us a little bit about that, and what excites you about the data?
GREG FORLENZA, MD: Yes. So that’s a paper that I was the first author on that came out in Diabetes Technology and Therapeutics in January of this year. The pivotal data will be presenting at Endo Society in March, so depending on when people listen to this, that may already be out. The prepivotal data was gathered in December and January of 2019 to 2020, so right prior to the pandemic, where we had people start using the full commercial build of the system in rental houses for a few days, and then they went home and wore the system at home for a total of 14 days. At the beginning of the study, we tested the different set points, so we had them try the 130, 140, and 150 set points, and then after a few days of each of those, we had them choose their own target, which was almost universally 110.
What we showed with that—comparing it to the data that they had just before the study, so a crossover comparison—what we showed was that the time in range was significantly improved. In all the age groups, for people who had pretty minimal hypoglycemia exposure, their hypoglycemia didn’t increase.For people who had a little bit more hypoglycemia exposure beforehand, their hypoglycemia significantly decreased. Generally, we saw about a 10% to 12% improvement in time in range with use of the 110 target.
In terms of a concrete number, that’s about 2 and a half hours per day that people are spending more time in range than previously, and that’s something that isn’t just statistically significant, it’s clinically significant, and it’s emotionally significant—2 and a half hours a day more of doing something that you like is something that you can feel and tell on a daily basis. And we also know from the studies on CGM [continuous glucose monitoring] data in larger populations that it’s associated with a significantly decreased risk of microvascular disease. So what’s the coolest thing about that, and what we’ve seen AID with [automated insulin delivery] systems is, it breaks that DCCT [Diabetes Control and Complications Trial] idea that you have a seesaw, and you have to pick either better average with more hypo, or less hypo with higher average. We’re able to just automate through that, and decrease the hypo, and decrease the hyper, or at least not increase the hypo while decreasing the hyper, and so it’s one of those rare circumstances in medicine where you’re not doing a trade-off, you’re just hitting a win-win. And that’s why I obviously love technology, is it enables us to do things that we thought previously not to be possible.
CAFFREY: So how are these systems covered by payers?
FORLENZA: So generally, we see pretty good coverage by payers, but obviously, we want to continue to see better and better, and universal coverage. Here in Colorado, where I practice, we’re very fortunate to have coverage for CGM for all of our pediatric patients, although we do run into issues getting CGM coverage for some of our adults, resulting sometimes in orphaning, where people who were able to get and be very successful with the system, you know, in their teens and early 20s, [are] suddenly not getting access to that system.
The pumps, we generally see very good coverage for, but obviously, as I mentioned earlier, with AID systems, we need both in order to have the system covered. The historical way of covering the insulin pumps has been the dermal medical equipment 4-year coverage model, where a pump is paid for, you have that pump for 4 years, it’s warrantied for four years, then when the 4-year warranty ends, you can get a different device, and it has resulted in this weird thing where people actually want their warranties to expire. Most other things we own, we don’t want our warranties to expire, but in this, sometimes people do, so they can change to get the newest model.
One of the exciting things that we’re doing, that is [happening] with the OP5 system is, they’re moving toward pharmacy coverage where, rather than paying for 4 years’ worth of a device all at once, the payer is just paying each time the person gets a box of pods. And one of the things that I didn’t mention in terms of features about OP5 is that it’s very much almost certainly looking like we’re going to have phone control of the systems. So there won’t be a [personal diabetes manager] or a piece of durable medical equipment that you get and have to keep and not break, and then have replaced for 4 years; you’ll just dose from your own cell phone. As a result, you’re not buying some expensive thing you have to maintain, it’s just every time you get a box of pods, the payer pays for the box of pods, and so it removes that huge up-front entry cost to pumps that has previously been frightening for patients, and also probably for payers.
That creates several benefits. One is, patients aren’t locked into any given design for 4 years or locked out of other designs foryears. But for payers, it also hopefully helps with this idea that “I’m going to spend 10 thousand-plus dollars on a device for someone who won’t have my plan a year from now.” And it also creates a month-to-month predictable cost, as opposed to a year-to-year unpredictable cost, and so I’ve been talking a lot about how technology can create win-wins.
I’m not a finance person, although my wife is, but I think that this kind of creates a win-win for payers and patients also, that patients can jump in, try a technology, hopefully be successful with it. And payers can have a less variable, more predictable, less kind of extreme to extreme payment structure, and patients can just get it at their pharmacy like they get everything else. So I really like this as a design in terms of a provider who wants to see my patients get something that they like, and so from a pump perspective, I think that this is a really cool jump forward. And obviously, I always continue to push, the key is going to be making sure that we get CGM coverage as well, because our patients and their families are going to need access to CGM for this to be successful, and a lot of people like me believe that’s an essential element of good diabetes control in 2021 and going forward.
CAFFREY: Well, speaking of access, in the last year, we’ve talked so much about the issue of health care disparities. Can you talk to us a little bit about what you’ve seen in terms of health care and technology access among, and disparities in diabetes technology use, among the type 1 population?
FORLENZA: Yeah, so this is a big area of discussion, and one that can get pretty emotional. The data from the Type 1 Diabetes [T1D] Exchange and all the registries that looked at this have shown that there continues to be a pretty big disparity in technology access and technology use across different racial and ethnic groups. And basically, the summary that my friends at T1D Exchange have said, is that an African American family with an annual income of over $100,000 a year has a probability of using technology that’s similar to a Caucasian family with an income of under $20,000 a year on Medicaid. And it’s unclear why this gap exists, although obviously, across the endocrinology field, we’re trying to be reflective internally, and thinking, is this something that comes from us not engaging in discussions with families as much?
Somewhat, it varies state to state, based on what Medicaid or Medicare pays for in certain populations, but a lot of it is providers. At Barbara Davis Center, we have a very large Hispanic population here in Colorado. About 15% of our patients are Hispanic, and one of the ways we’ve started to bridge this gap is, we developed a Latino clinic where we have Spanish-speaking providers, Spanish-speaking nurses, Spanish-speaking dietitians and device trainers, and that has helped to increase the use of technologies.
I’ve analyzed my own practice data, and I think I kind of benefit from here from the “if all you have is a hammer, everything looks like a nail” phenomenon, where I talk about technology with everyone. I get enthusiastic, and sometimes wildly so, about technology with all my patients, from day one, and so I think that also helps.
I very much believe that it’s provider driven in terms of not trying to sell people on technology. But the other element is that historically, we’ve had these ideas that people had to earn technology, that you had to have a certain hemoglobin A1C to be successful with technology, you had to have diabetes for a certain amount of time, you had to be testing a certain amount of times per day. And the studies that we’ve done have proven again and again and again that those were very paternalistic ideas, not rooted in data, not rooted in literature, that aren’t supported by real-world use, that people with the newest technologies who weren’t previously testing probably had some barrier about doing finger sticks on a schedule that’s overcome by using CGM, or they can be successful with CGM. People who weren’t bolusing previously with automated systems can be more likely to bolus, and our group is gathering some of that data now. So it just gets back to that idea that as long as your patients are willing to change their infusion sites every 3 days, the percentage of people who can be successful with technology is dramatically larger than what you thought it was, and you can see tremendous gains.
We’ve looked at this in some of our studies that have done this, we’ve seen kids who started with A1Cs of 10 have their A1Cs come down to 7.5 to 8, 2 to 4 times the delta that we see in other studies, because they have so much room to gain, and they’ve been successful with technology. And you want to talk about complication reduction, you bring someone’s A1C down from 10 to 7.5, that’s bigger than the DCCT in terms of what the effect was, and these are people who are going to go from high risk of complications to minimal risk of complications. I obviously feel emphatically that these are the people we should be targeting for technology because they’re the ones who are going to see real long-term macrovascular benefits from it.
CAFFREY: Well, Dr Forlenza, this has been an absolutely fascinating discussion. I’m so thankful for you to join us. For all of us at The American Journal of Managed Care®, I’m Mary Caffrey, and thank you for joining us.
For all of us at The American Journal of Managed Care®, I’m Mary Caffrey. I want to thank Insulet for bringing us today’s podcast and thank you to the listeners for joining us. For more updates in managed care be sure to visit ajmc.com and sign up for our e-newsletter. AJMC® is also on social media. On twitter, follow us at @AJMC_Journal and on Facebook you can like us at The American Journal of Managed Care® and follow our AJMC® page on LinkedIn.