Kyle opened the discussion by commenting that COVID-19 highlights existing healthcare inequities, particularly for non-white communities in the US, with access, insulin affordability, and medical devices a constant worry for the diabetes community. The mission of DiabetesWise is to educate and empower people with diabetes, particularly around diabetes devices.
How has COVID-19 changed the way medical device companies have adjusted operations during the pandemic?
Dr. Habif said that the Tandem staff is fully operational but most employees are working remotely, instead of in-person in their San Diego and Boise offices. “In California [where Tandem is headquartered], healthcare operations are deemed critical by the state, so we can continue to provide products and services to customers all around the world, and our manufacturing and warehouse facilities continue to operate as normal, with the necessary safety accommodations in place.” She noted that remote training was allowed by the FDA, due to COVID, and as a result, they've completed approximately 4,500 remote trainings so far in 2020 (compared to 1500 in total for 2019).
Dr. Vigersky echoed Dr. Habif's comments regarding a remote workforce, also citing that Medtronic “literally pivoted - almost overnight - to all virtual training, and we have done that since March. Over 11,000 trainings on our pumps and CGMs. … It's been really gratifying to see how our trainers, the patients, and healthcare providers have really come together and made this work.”
Does COVID-19 cause insecurity and interruptions in the supply chain?
Dr. Trang Ly, from Insulet, said that their team has been dealing with the COVID-19 crisis since January, as they have manufacturing facilities in both China and the United States. “What's really interesting is that, in China, our employees actually live on-site. So when the COVID crisis became more prevalent, we had to isolate all of our employees for two weeks when they had gone home and come back to the facilities. We had to take a lot of precautions to [ensure] that production was not interrupted.” They have been able to maintain production throughout, and they monitor the health and well-being of both their employees and their patient base.
Janice MacLeod, from Companion Medical, also said that their San Diego facilities are deemed essential and have continued production uninterrupted. Most of their staff is working remotely, with the “biggest adjustment for our field-based sales and clinical teams that are so used to being out there and working collaboratively with healthcare providers, who are then interacting with people with diabetes.” She also pointed out that COVID is disproportionately affecting people with diabetes, leaving providers connecting with patients to ensure access to supplies and proactively working to make sure their patients are able to achieve and maintain good diabetes management as a way to mitigate risk.
Are there programs in place to assist patients who have lost their insurance or are struggling with access?
Dr. Ly said that there were financial assistance programs in place prior to COVID, and have been expanded for US and Canadian “Podders.” “The best way to get information is to call our customer care line because they can really walk through the individual needs assessment.”
Dr. Vigersky said that Medtronic has “always had flexibility in their payment system, but as a result of COVID, we launched something called ‘Medtronic Assurance,' [which is] three months of free supplies for patients who use our sensors and pumps” who have lost insurance due to COVID.
Janice MacLeod added that - prior to COVID and throughout - patients with diabetes can access InPen at an affordable cost. “It's a prescription-only device, covered as a pharmacy benefit, and Companion Medical has a special copay assistance program,” leaving an annual copay of $35 for commercially insured patients.
Dr. Habif rounded out the commentary by saying that it is encouraging to hear all companies talking about their commitment to access to the best of their ability. She almost mentioned that the Tandem t:slim X2 insulin pump is a software-updateable pump, and that software upgrades are available at no extra cost through 2020, allowing users to access new features without needing to buy new hardware.
How can diabetes devices help communication with healthcare providers during telehealth visits?
Janice MacLeod said, “Now, more than ever, it's so important to recognize the ability to access data remotely and share that data with care teams remotely. And now we can continue to do that and continue to make informed decisions with our patients, even when we're not able to be in-person. … [and with InPen,] now we're able to see dose data for the first time for people using injection therapy.” According to MacLeod, a patient using InPen can send a data report remotely to their clinician through the Companion Medical app, allowing the clinician a chance to view the data in a telehealth visit.
Dr. Ly said that the move to virtual care has seen a lot of satisfaction from their new Podders, with the addition of a software update that allows the Omnipod PDM [remote device for Omnipod] to send data directly to the cloud, allowing healthcare providers to log in and view patient data.
Tandem released a mobile app a few weeks ago, which allows the Bluetooth from a smartphone to connect with the t:slim X2 pump, creating a secondary data display on the phone. This phone display provides “a lot more visibility to your therapy because there's just a lot more digital real estate on a smartphone interface,” said Habif. The mobile app wirelessly uploads data to the Tandem cloud system, where healthcare providers can log in through t:connect's web application to view data.
And Dr. Vigersky reiterated some of the points made by other commenters, adding that “the ability to get data and have the physician look at it without having a patient come into the office is really a game-changer.” Medtronic's CareLink reports provide a “robust but clear data display that is really helpful for the healthcare provider.”
Will there be any potential development delays as a result of COVID-19?
Dr. Ly talked about the Omnipod 5 powered by Horizon, which is an automated insulin delivery system currently in clinical trials. The pump will have phone control and will be integrated with Dexcom. Insulet also has plans to work with Libre to bring Omnipod 5 powered by Horizon to market with the Libre 2 sensor. Insulet also has Omnipod with Tidepool Loop - the commercialization of the DIY algorithm.
Janice MacLeod discussed the importance of adding more data to the context of multiple daily injection therapy through InPen, mentioning that the smartpen option offers “similar dosing support for people who don't want to [pump].” InPen has also recently received expanded indication for all ages, and the company is also exploring options to help expand the smartpen option for people with type 2 diabetes on injection therapy.
