For years, Dexcom has been one of the leading competitors in the continuous glucose monitoring space. While the company is focused on looking ahead, that’s not to say there haven’t been some bumps in the road along the way.

In 2018, its Dexcom G6, an integrated continuous glucose monitoring system, got the green light from the FDA, making it the first interoperable CGM to get the designation. However, after the system launched multiple customers began to notice that some devices' applicators were getting stuck to the wearable.

The company acknowledged that the issue has impacted what it is calling a “small percentage” of the sensors, and said it has also worked to solve the issue.

“We have had some failure rates in the field that some users experienced. When they pressed the button to deploy the sensor, it doesn’t complete the cycle of deployment,” Jake Leach, Dexcom's chief technology officer, said. “So the applicator doesn’t release from the wearable, so you basically have the wearable and the applicator and they have not come apart like they’re supposed to. It’s a very low number of devices that have done that, but it’s enough that we weren’t happy with what we were seeing.”

This issue did create some tense moments for caregivers and users, who were unprepared for this kind of event. Nicole McLemore, who has two children with diabetes, said she made sure to upgrade to the G6 as soon as they were eligible, noting that it was supposed to be more accurate and smaller than previous versions. However, the applicator did become an issue for her family.

“On my five-year-old we have had four [applicators] now that have gotten stuck on her,” McLemore told MobiHealthNews. “By stuck it means when you go to insert the applicator – you press a button and it goes in … but they jam and get stuck in them, and you have a little kid that is screaming.”

On social media, diabetes groups were helping each other fix this issue – with some suggesting that hitting the applicator with a wooden spoon would help it release.

“The first three [applicators] I didn’t know about hitting the side with a wooden spoon to help it retract. ... But you should not have to use a wooden spoon,” McLemore said.

Laura Ricci, whose son uses the G6, said she saw it happen to him and heard about the issue on her Facebook group as well.

“It’s common I have tons of posts about it on my diabetes group,” she said. “I have one of the largest diabetes groups for Type 1 diabetes on Facebook, and I can’t tell you the amount of times that people are posting about this, and showing the pictures of the thing attached to the body and they are hitting it with a wooden spoon and some people have found a little hole in the handle of a device and stick in a paper clip to see if they can release it or banging it with the back of a hammer. So it’s a manufacturing defect.”

Amy Martin had read about the issue on the Facebook group, but when it happened to her son, she was frantic.

“He was not in pain but freaking out a little, and since I was in my tool drawer I picked up a screwdriver and hit the applicator with the handle of the screwdriver. It then released,” Martin wrote.

Leach said he sees this defect as a lesson learned for the company, and said they are addressing it.

“As we continue to scale the product during our manufacturing processes, we’ve learned about how the equipment has been interacting with the device, and we’ve found that there were some issues in the processes of manufacturing,” he said. “And so we’ve improved those. It didn’t impact all the devices. It was a really small number, but we did have some issues where we needed to go in and fix the equipment and take a look at it. The good news is the users, if they do experience that, they can just peel the device off and put on another one, and we totally understand that’s an inconvenience, but it’s not a dangerous failure. It’s just a frustrating one that we don’t want our customers to experience.”

McLemore said that if she is down to the bottom of her supply, this can be more than just an inconvenience – though she notes she is generally well stocked with backup sensors. She also noted that her experiences with customer service varied greatly depending on the person at the other end of the call.

“It’s a kind of a lesson learned – more, different kinds of inspections on the line. What else do you need to do when you scale, when you bring up a new piece of equipment? Part of scaling to build more product is you bring in new pieces of equipment. Often there’s been enhancements made, so that they can produce more devices per minute, for example. And so you always have to double-check that none of those things have impacted the device. And you know, you always learn something when you turn up production, so we’ve learned a tremendous amount over all the years manufacturing sensors at scale.”

Happify Health has developed and launched a new digital mental health program with the American Heart Association (AHA) that aims to reduce stress and encourage healthy behaviors among people with high blood pressure and high cholesterol.

Patrick Burke, head of healthcare at Happify Health, told MobiHealthNews that his company's content team and the AHA's experts have been working together for more than 18 months to develop the Heart and Mind product.

It consists of 10 four-week programs that teach users stress-reduction strategies while encouraging regular activity and heart-healthy eating habits. It particularly focuses on "Life's Simple 7," a collection of risk factors identified by the AHA that can increase wellness and reduce cardiovascular deaths.

Much like Happify Health's broader catalogue of digital mental health and behavior change programs, Heart and Mind is being delivered through the company's platform for employer and health plan customers.

WHY IT MATTERS

The AHA is well aware of the link between mental health and cardiovascular health, as evidenced by informational materials on the organization's website and clinical data presented at its most recent Scientific Sessions.

And while Patrick Wayte, SVP at the AHA's Center for Health Technology and Innovation (CHTI) told MobiHealthNews in an email that the organization "continues to provide a range of traditional methods to reach people as well," it chose to combine its heart-health expertise with Happify's digital behavioral health intervention "knowing that people are often challenged in multiple ways with regard to their health, and that one issue impacts another."

From Burke's perspective, AHA's decision to pursue the partnership is also an acknowledgement from the long-standing professional organization that digital interventions can amplify the reach of their health and wellness teachings.

"[Digital platforms allow AHA] to scale the deep knowledge they have in specific condition areas," Burke said. "It also helps them marry it with expertise like Happify has related to digital mental health, because the Holy Grail of behavior change is to get underneath the things that are getting in all of our ways as individuals. That's what makes the work that we've done together so meaningful – because we've been able to bring each of our expertise to bear for the same goal."

Burke said that Happify's digital programs are often the result of content collaborations. He noted that the company has tapped more than 40 experts from around the world when putting together its mental health products.

Still, to partner and release a product with the nearly 100-year-old clinical organization is a noteworthy milestone for the growing digital health company, he said, and paves the way for the Happify's upcoming and in-progress collaborations across the healthcare industry.

"To work with someone as impressive as the AHA on a condition is a natural outgrowth of what we're doing – we've just expanded it into working on this chronic condition with them," Burke said. "We're looking at physician burnout with another partner of ours, CoreWellness, and we're also a digital therapeutic company that's going through FDA approval, ... and we've got a 10-year agreement with Sanofi [to] treat multiple sclerosis."

THE LARGER TREND

Through CHTI's Innovators' Network, the AHA has been dipping its toes into new medical technologies including digital health.

"Fundamentally, we are endeavoring to define new, evidence-based approaches by working with scalable, digital-health platforms/technologies/solutions where we can identify improvements in health understanding/knowledge and also ultimately health outcomes," Wayte said.

Among the organization's recent projects was a digital health-pitch contest held during November's Scientific Sessions, in which finalists including Happify, Welldoc, PhysIQ, Qura and others were edged out by Pittsburgh-based Forest Devices' stroke-triage platform for EMS teams.

And as for Happify, the company announced in April the launch of a screening and referral hub for employees and health plan members called Happify Connect. The company has also been offering free resources to help manage stress and anxiety during COVID-19 and racial injustice.