Automating Blood Glucose Monitoring Through New Technology

Traditional Blood Glucose Monitoring

Since the first blood glucose test strip was developed in 1965, researchers and biomedical engineers have built off the basic concept to develop tools and technologies for advanced, at-home blood glucose monitoring. It wasn’t until the 1980s that at-home blood glucose meters and strips were made available and more accessible to the broad patient population.

Today, blood glucose monitoring has evolved significantly, increasing accuracy and precision. Additionally, the development and launch of continuous glucose monitoring (CGM) systems have revolutionized diabetes care.

Despite the availability of CGMs, some patients with diabetes opt to use traditional blood glucose monitors for varying reasons, including patient preference, how often they need to check their sugar, and other parts of their treatment plan. For example, Novi Health notes that blood glucose monitors measure glucose levels directly in the blood rather than sugar levels in interstitial fluid (ISF), as CGM devices do. Explaining that while interstitial sugar levels are directly related to blood sugar levels, the changes can be delayed in ISF, meaning blood glucometers can detect changes in blood sugar faster than a CGM device.

Despite the critical role of blood sugar monitors in diabetes care and management, these devices have some limitations. The multi-step process and number of materials needed can pose some limitations and inconvenience patients.

“It all depends on the user being able to complete these actions,” emphasized Raul Escutia, Vice President of Research and Development (R&D) at Intuity Medical, in his interview with LifeSciencesIntelligence.

The seemingly easy steps can pose a significant barrier for patients with vision challenges, tremors, or dexterity issues.

POGO Automatic, An Automated Glucometer

That is where the company’s new, automated blood glucose monitor, POGO Automatic, comes in. POGO Automatic requires fewer steps from the user.

“[Patients] open the door, load the cartridge, close the door, press power, put their finger down, and that's it,” Escutia listed, referring to the steps required for traditional glucose monitors.

Compared to the traditional BGM, POGO Automatic eliminates many manual steps, making glucose monitoring simpler throughout the day.

“This is easy to hold and doesn't require any alignment,” he added. “I don't even have to look at it. I just drop [the cartridge in], and it auto-aligns. And so we've taken all the manual steps and turned them into something automatic that happens transparently to the user.”

Medical Device Design Process

Escutia noted that early in the design process, the engineers on the design team were testing the process, highlighting that — even without diabetes experience — the product design is intuitive and easy to use. “We were trying to design something very easy for everybody,” he emphasized.

On one hand, patients with type 1 diabetes may be very young, with diagnoses occurring as early as six months old. Conversely, a large majority of people with type 2 diabetes are diagnosed later in life. With that in mind, the researchers hoped to design the product to cater to some of the most complex cases, including dexterity or vision issues. By simplifying this product for that population, the use is significantly easier for the broader population.

“We get the simplicity by integrating all of those manual actions that the user has to do,” Escutia noted. “We had to design complex mechanisms that could do that. Our target was simplicity and ease of use, but we got there by designing very complicated mechanisms.”

The design team looked at each step and tried to equate it to something they could automate.

“As we went through and designed all these, we took the manual action turned into something automatic.”

Additionally, the team constantly used insights from patients and providers to guide their design process and understand what is actually essential to the target patient population.

“The group of healthcare providers that were most involved would be the educators. Whether it's the nurses, the nurse practitioners, the nurse educators, it was that population who was the most involved,” Escutia noted. “We had a core group. As we develop ideas, we [would say], ‘Hey, look, we're trying to do this. What do you think of this feature? What do you think about this interface?’ and ‘Hey, we need to decide. We're going to have to choose between a particular feature needs to go in or go out.’”

Medical Device Validation

Throughout the validation of the tool, the design team at POGO Automatic continually brought in new users and patients to test the product.

“Our internal validation was pretty straightforward. [The design team would] give [the device] to somebody who's never seen [it], give them the instructions, and sit there and watch.”

The team would watch the patient, and when the design and process were right, they wouldn’t need to intervene for the patient to use the device properly.

"It, like any medical device, underwent formal validation, but it was also iterated and tested with patients throughout. By the time it reached validation, it wasn't a surprise that it would work."

Collecting the Droplet

While the automation process was the most considerable undertaking, Escutia emphasized  that the most challenging aspect was determining the method for collecting a precise drop of blood, ensuring the correct volume, and transferring it to the test strip.

“On the small scale, the droplet itself was a huge challenge,” he noted. The design team had to figure out how to accommodate different skin types. For example, some patients have thinner skin, so a more intense prick will make them bleed more than is necessary to collect a drop of blood. On the flip side, other patients have thicker skin or calluses from years of checking their blood sugar, so getting a drop of blood with a lighter prick can be challenging.

“We had to figure out how to [collect blood] consistently. Then, we need to move this tiny droplet of blood from the skin into the device.”

The designers recruited a broad group of patients of varying ages, ethnicities, and backgrounds to ensure the device was effective on a more comprehensive range of people. Within the company, they also had people from different roles to test out the device, as varying levels of handiwork could affect skin elasticity and roughness.

Patient and Provider Benefits

LifeSciencesIntelligence also spoke to a provider who prescribes the device for their patient and a patient who has been using it regularly to get some input on whether the tool provides significant advantages over other glucose monitors.

“In my practice, all of my patients with diabetes are prescribed this device. I even prescribe it to patients who are already using CGM devices because the POGO Automatic is more accurate than a CGM device in the setting of hypoglycemia. For squeamish or needle-phobic patients, the POGO Automatic uses the least amount of blood, and the needle is hidden,” said Philip Rabito, MD, when asked how he uses POGO Automatic with his patients.

Sandy Reekstin, a patient using the device, highlighted its simplicity, noting that the learning curve is relatively small. Another feature she particularly highlighted in her conversation with LifeSciencesIntelligence is its size.

“It's also discreet,” she said. “I don't have to pull out my test strips and pen. If I'm out socially, I'll reach into my pocketbook and check my sugar.”

She also added, “I'm a nurse; I work nights. Sometimes, I can't stop and do all these things. I put [the POGO Automatic device in my pocket] and stuck my hand in my pocket [to quickly check my sugar]. I can check it and keep going without this long interruption in what I'm doing.”

LifeSciencesIntelligence asked Reekstin to explain how the device has impacted how she managed her type 2 diabetes.

“Compliance,” she responded. “I'm able to check more frequently. I'm able to keep track because I'm able to share the readings with my doctor. It's a game changer.”

“The bottom line is, the more frequently patients check their blood glucose, the easier it is for me to make adjustments in their regimen and ultimately to control the diabetes. The POGO Automatic makes it easier and more convenient for patients to check their blood glucose; therefore, most patients on the device are providing me with more data,” concluded Rabito.

Medical Device Sustainability

Throughout his discussion with LifeSciencesIntelligence, Escutia mentioned the device’s sustainability factors.

“In some ways, it came naturally because there's no dead space or feature that, if removed, would hinder the device's function,” he began. As the team designed the device, they looked to make it as sleek as possible by eliminating anything that didn’t serve a function in the device.

However, Escutia emphasized that, as a medical device, some sustainability limitations cannot be avoided.

"I'd love to grind and reuse the excess material. When parts are molded, there's usually a little extra. If we were producing toys, we could recycle that material efficiently,” Escutia continued. “However, in medical devices, we avoid doing so to prevent mixing multiple materials and jeopardizing the functionality of subsequent batches."

With that, Escutia noted that, in future phases, sustainable thinking would extend to how they package the product.

"For example, do we need to print every single manual? I'd love it if everyone took our manual, read it front to back, and then did their first test. But the reality is that's not happening. So, if we eliminate the manual, it reduces paper usage, yet it's still accessible for patients online."

Other factors to consider are the size of the box, how it can be optimized to fit more boxes in each case, the material it is made of, and more.

With many blood glucose monitors on the market, POGO Automatic is another diabetes management tool available to patients and providers.

Editor's Note: This article has been edited to add Automatic to the device's name and reflect Raul Escutia's positon at Intuity Medical.