New diabetes technology expected to improve customization, availability of real-time data
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Advancements in connected insulin pens, continuous glucose monitors and insulin pumps are allowing more comprehensive and real-time data to be available to people with diabetes and their care teams, according to two speakers.
New generations of diabetes devices are providing more information to health care professionals and improving metrics, such as time in range and HbA1c, for people with diabetes, according to Diana Isaacs, PharmD, BCPS, BC-ADM, CDCES, FADCES, FCCP, a clinical pharmacy specialist and CGM program coordinator in the department of endocrinology, diabetes and metabolism at the Cleveland Clinic Diabetes Center, and Dhiren Patel, PharmD, CDECS, BC-ADM, an adjunct associate professor of pharmacy practice at Massachusetts College of Pharmacy and Health Sciences in Boston and an endocrine clinical pharmacy specialist at Cardiometabolic Concierge Clinic, who spoke about the latest in diabetes technology at the Association of Diabetes Care & Education Specialists virtual conference.
“New insulin pumps, CGM and smart pens offer many options for people with diabetes,” Isaacs said. “The new technology is making it easier to monitor glucose, give insulin and track data.”
Connected insulin pens a ‘game-changer’
Isaacs and Patel said the devices that could most change diabetes management in the near future are connected insulin pens and caps. According to Patel, providers struggle to obtain accurate insulin dosing data without a smart device and find it difficult to tell whether a person has an improper or poorly timed dose. The use of a connected insulin pen helps fill in those data gaps by calculating doses based on current glucose levels, helping to prevent missed doses, and sending reminders to the person with diabetes for the next dose or when insulin is going to expire.
“Connected pens are something a lot of people can take advantage of, but don’t really know about,” Isaacs told Healio. “That’s going to be a game-changer for people with daily injections of insulin, because historically we have not been able to see any data with that. We have no idea what doses people are actually taking or when they are actually taking it. This is an area that’s really going to explode.”
The Medtronic InPen is one of the FDA-approved smart insulin pens currently on the market. It is a reusable pen for up to 1 year without charging and uses Bluetooth to send real-time data to the InPen app.
Another FDA-cleared product currently on the market is the Bigfoot Unity System (Bigfoot Biomedical). The system includes two smart pen caps, one for the person's rapid-acting insulin pen and one for the person's long-acting insulin; a mobile app; and a FreeStyle Libre 2 integrated CGM sensor. The components will automatically capture and combine integrated CGM data with dose timing.
There are a couple other smart insulin pens currently in development may come to the market soon:
- The NovoPen 6 and NovoPen Echo Plus (Novo Nordisk) uses near field communication to transfer insulin dosage data from the pen to the smart device and is compatible with long-acting basal insulin and rapid-acting bolus insulin.
- Lilly is developing a smart button attachment for its prefilled Tempo insulin delivery pen. In February, Lilly shared its plans to collaborate with Welldoc on commercializing a new version of its BlueStar app in the U.S. to pair with the smart button. Submissions for both the smart button and the new version of the BlueStar app will be complete in late 2021. Outside of the US, the button will be compatible with diabetes management platforms, since Lilly has compatibility agreements with Dexcom, Roche, Glooko and myDiabby Healthcare. A CE mark is anticipated for late 2021.
Patel said the smart insulin pens and caps are going to lead to better personalized treatment for people with diabetes.
“We have more visibility, we have more data to make more informed decisions with our patients around their diabetes care,” Patel said. “At the end of the day, this better data leads to better control, and if there’s better control, we’re going to have better outcomes.”
Smaller, more affordable CGM in development
Isaacs said each new generation of CGM devices is further improving the ability to gather accurate data on glucose levels. This is crucial as new CMS rules approved earlier this year are expected to make CGM more accessible for Medicare beneficiaries with diabetes.
“With CGM, we’re continuing to see accuracy improve as well as cost,” Isaacs told Healio. “Hopefully cost is going to continue to come down as the Dexcom G7 is going to be disposable. We already know the FreeStyle Libre is the lowest cost and that’s disposable. Hopefully that’s going to bring more CGMs to more people.”
The CGMs in the pipeline are slated to improve on the current generation of devices. The Dexcom G7 is expected to shorten warm-up times to 30 minutes and be fully disposable. The Medtronic Guardian 4 will not require calibration like its predecessor and will be non-adjunctive. The new Eversense CGM will include a 6-month wear time or a 1-year wear time with weekly calibration. The Abbott FreeStyle Libre 3 will be the device’s first real-time CGM with reduced size and an easier to use applicator.
New insulin pumps offer more flexibility, ease of use
The next generation of hybrid-closed loop devices is expected to give people with diabetes more flexibility with insulin administration. The Omnipod 5 (Insulet) will include glucose targets adjustable by time of day, a feature called HypoProtect for times when the wearer has a reduced need for insulin, and a Smart Bolus calculator informed by CGM values and trends. The Medtronic 780G also includes an adjustable glucose target of 100 mg/dL or 120 mg/dL, automatic correction boluses every 5 minutes, and Bluetooth connectivity.
In a comparison of three trials involving the Omnipod 5, Tandem’s Control-IQ and the Medtronic 780G, all three devices showed an increase in time in range, with all three devices increasing time in range to more than 70%.
A unique system in the pipeline is the Beta Bionics iLet. While it can hold only 160 units of insulin, it has hormone automation with both glucagon and insulin and is programmed by entering only body weight and starting the CGM. The device also uses meal estimates instead of carbohydrate counting.
Tidepool Loop, an automated insulin dosing app, could also be a game-changer for people with diabetes. Isaacs said it will have integration with Dexcom G6 and is much more customizable than current devices on the market. The Tidepool Loop applied for FDA approval in December 2020.
Editor's note: This article was updated on Aug. 17, 2021, to clarify details about the Bigfoot Unity System. The Editors regret the errors.
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Isaacs D and Patel D. S-21. Presented at: ADCES21; Aug. 12-15, 2021; (virtual meeting).
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