What are the things that excite you about diabetes devices?
“Automated insulin delivery - meaning that insulin is flowing when you're higher and slowing when you're lower - is an amazing thing that has happened recently,” said Dr. Lal. “It's been brought about largely by leaps and bounds advances in CGM technology. We finally have the opportunity to … help make these really great products.” He went on to add, “One of the principle issues is that there seems to be a tug-of-war, in industry, about who has the best time -in-range, who gives you the best glycemic control. I honestly think, as a person with diabetes and a provider, that's not as important to me above a certain threshold. If you're in range more than 70% of the time, you're not going to get microvascular complications. Right now, with closed loop [technology], we're achieving levels of control that we've only dreamed of. The highest time in range in the DCCT … was only about 75%. Now, we're talking about [commercial] systems offering 72% and 75% [time in range]. We've reached a stage where the glycemic control is not the crucial aspect; it's the device usability.”
Dr. Lal also added, “My excitement for the future is fully closed loop technology … but also useable technology, and most important, affordable technology … what matters is do we have justice for everyone.”
What is open-source diabetes technology?
“Open source automated insulin delivery, some people refer to this as DIY technology,” said Dr. Lal. “I don't like that term because everyone is working together to make these systems happen - it's not just one person. I prefer 'open source' because it speaks to the openness of the systems being created. They are not hidden under intellectual property labels that industry tends to give things. What started this open source movement was the desire for a father to see his son's [CGM] data. There was code available in a system called Nightscout that allowed one to send CGM data up to the cloud. Dexcom Share came along soon after. Medtronic had the first FDA approved closed loop system (670G) - the first hybrid closed-loop system was OpenAPS, developed by Dana M. Lewis and Scott Leibrand. Subsequently, we've seen the development of Loop and Android APS. What this [the open source community] is really doing is forcing the industry to keep up. And when you don't have regulatory burden over your head, you can innovate at a very rapid clip. We're learning from the people using [DIY] systems so that we can improve not only those systems, but the ones supplied by industry, as well.”
How has COVID-19 affected diabetes device usage?
“One of the benefits of being sheltered in place is that if you have not used the technology before, you have the unique opportunity to start in a very controlled situation. This was sort of an 'ideal time' where the rest of life was not overflowing and you have some time to sit down and try something new,” said Dr. Lal. “I also think, that from a telehealth perspective and [in terms of] delivering care, having CGM data as a download is super useful for the provider.”
COVID-19 has affected the supply chain of many household items, like toilet paper, and people with diabetes have concerns about accessing their supplies. “How is insulin different from toilet paper? Toilet paper doesn't require a prescription to obtain,” said Dr. Lal. “You don't have to run toilet paper through a pharmacist and an MD. One of the reasons we have not had the same problem where you can't obtain a supply is because there are checks and balances on the supply chain. Even if you could get two years' worth of insulin, I highly suggest you do not do that. Get what you need. It only becomes an issue once people start hoarding supply.”
How can people with diabetes continue to be safe during COVID-19?
“How much is observational data worth? One has to look critically at any evidence that is given to you. I can probably tell you that masks protect people from infection,” said Lal. Dr. Lal cited the circumstance where two hair stylists who both had COVID-19 exposed over 100 people, but the practice of the hair stylist and person getting the haircut both wearing masks resulted in zero transmissions. “To me, that's reasonable data. But it's not a randomized control trial where we had all the factors. The CDC gives us pretty good guidelines - stay six feet apart, wash your hands thoroughly, wear a mask. It's hard to tease apart what's going on with COVID-19 and the diabetes space. There was sobering data from the NHS that showed a 2.5x increased risk of death in hospitalized people with type 2 diabetes, and 3.5x increased risk for hospitalized people with type 1 diabetes. But that doesn't tell you what other factors were going on.” Dr. Lal encourages people with diabetes to take caution and keep blood sugars as well-controlled as possible.
What should a person with diabetes do if their supply chain for diabetes devices and supplies is disrupted?
“Shipping services have been delayed [as a result of COVID-19], and that has resulted in some packages running later than predicted.” Dr. Lal suggests that, if you find yourself in a situation where your insulin supply delivery is disrupted, to go to Walmart [in the US], where they sell Regular and NPH insulin, over the counter. He also talked about states that have passed affordable insulin bills, like in New Mexico, where the cost is $35 for any vial of insulin. “You know, when Banting and Best discovered insulin, they deliberately did not put a patent on it so that everyone could benefit, and would they not be spinning in their graves right now if they were to see the state of things we face today.”
For pump disruption, in terms of transitioning back to multiple daily injections (MDI), the general tendency is to convert basal rates back to a long acting insulin and to use the same carb ratios and sensitivity factors, if pump use is disrupted. “You can still use the bolus calculator on your pump, even if you're not wearing it,” Lal added.
Regarding CGM disruption, Dr. Lal recommends having a glucometer at home. “It's still useable, it's still accurate, and you can still use it to check your blood sugar.” He suggests checking before meals, at bedtime, overnight occasionally, and wherever else you would intervene and take action. “Have a glucometer as a backup, even if you've had a [CGM] for years.”
For disruption with closed loop systems, Dr. Lal said, “Closed loop systems can fail, and they can fail in a number of ways, but when they do fail, you want them to fail elegantly. What this means is that in most cases, when a closed loop system stops functioning, you can go back to your open loop settings.”
