On World Diabetes Day, it’s worth taking a look back at the last 10.5 months in the diabetes technology space.
The date, which marks the birth date of the inventor of insulin, brings out all sorts of initiatives from various companies involved in innovating these technologies (read about those HERE). Those companies have contributed to some of the biggest stories of the year so far.
Developments across the usual suspects in continuous glucose monitoring and insulin delivery feature on this list. Many of those known commodities featured on our 2024 list of the nine biggest diabetes tech companies in the world. However, some other players made waves over the course of 2024.
From January 1 through Nov. 14, here are some of the most-read stories in the diabetes space this year:
Abbott and Medtronic strike diabetes partnership
Two of the biggest names in medtech in general, not just diabetes, have joined forces.
In August, Abbott and Medtronic announced a partnership arranging for Abbott to develop a CGM sensor and for Medtronic to sell it. This prospective sensor works exclusively with Medtronic devices.
The sensor is based on Abbott’s FreeStyle Libre platform and pairs with Medtronic’s automated insulin delivery technology (the latest generation being the MiniMed 780G) and smart insulin pen systems, such as the InPen system. Medtronic’s systems previously used its own CGMs, such as the Guardian 4 and the Simplera platform, and the company intends to continue using those systems as part of a comprehensive CGM portfolio.
Jared Watkin, EVP of Abbott Diabetes Care, said the partnership “pairs two global leaders in glucose sensing technology and insulin delivery.”
“Our partnership with Abbott allows us to expand access to our advanced automated insulin delivery and smart [multiple daily injection] systems that deliver best-in-class outcomes with the most widely used CGM in the world,” said Que Dallara, EVP and president, Medtronic Diabetes.
Dexcom rolls out new sensor
In a year full of major developments for Dexcom, the one that grabbed Drug Delivery Business News’ readers most was the company’s rollout of the Stelo over-the-counter CGM.
Dexcom became the first company to receive FDA clearance for an OTC CGM when the FDA cleared Stelo in March. The company designed Stelo, a small, wearable sensor, specifically for people with type 2 diabetes who do not use insulin. About five months after clearance, in August, Dexcom began its launch for Stelo.
Worn on the back of the arm, the sensor provides insights directly to a user’s smartphone. Stelo features a 15-day wear based on the G7 platform. It offers a software experience tailored specifically for non-insulin users. The company said it makes it easier for the target population to access CGM and offers an option for those who don’t have insurance coverage for CGM.
(CEO Kevin Sayer spoke to Drug Delivery Business News about the next steps for Stelo at ADA 2024 — read about it here.)
In other major Dexcom news, the company garnered lots of attention for the launch of a direct-to-watch feature for its G7 CGM and submitted a 15-day CGM to the FDA for review.
Tandem launches new automated insulin pump
Mobi was one of the biggest stories of 2023, when the FDA cleared Tandem’s pump for people with diabetes ages six and up in July 2023. It captured headlines again in February when Tandem launched it in the U.S., marking the rollout of the world’s smallest durable automated insulin delivery (AID) system.
Mobi features a 200-unit insulin cartridge and an on-pump button to provide an alternative to phone control for insulin boluses. It comes in at less than half the size of the existing Tandem pump system, the t:slim X2 pump. Mobi can fit in a coin pocket, clip to clothing or go on the body with an adhesive sleeve.
The system features the same Control-IQ technology that powers the established t:slim X2. Control-IQ, an advanced hybrid closed-loop automated insulin delivery feature, predicts and helps prevent high and low blood sugar. It leads to improved time in range throughout the day and night.
Said John Sheridan, Tandem president and CEO, “With this launch, we are executing on our strategy to offer a differentiated portfolio of durable insulin pumps, providing choice, along with new options in wearability.”
Roche unveils new CGM powered by predictive AI
The Swiss company first unveiled its Accu-Chek SmartGuide in an event at the Advanced Technologies & Treatments for Diabetes (ATTD) conference earlier this year. Accu-Chek SmartGuide features a 14-day wear time, a one-step application process and watertight properties.
Roche says Accu-Chek SmartGuide utilizes predictive AI to provide glucose predictions showing estimated developments for different timeframes. Based on the CGM data, the system’s app shows where glucose levels might go in the next two hours.
The company designed the CGM to address the critical unmet needs associated with managing diabetes and glycemic targets. Every five minutes, the CGM sensor sends glucose values measured in real time to an application. The predictive app then utilizes those values and other available information to detect patterns and predict future glucose levels.
Integrated AI helps to indicate hypoglycemia risk within the next 30 minutes. It also helps to forecast low glucose levels and estimate the risk of nocturnal hypoglycemia.
Roche won CE mark for Accu-Chek SmartGuide in July.
Abbott launches its own OTC CGM
Within two weeks of Dexcom’s Stelo launch, Abbott brought its own over-the-counter glucose biosensor — Lingo — to the market.
Abbott received FDA clearance for Lingo and its Libre Rio over-the-counter (OTC) CGMs in June.
Lingo features a biosensor and mobile app designed for customers who want to improve their overall health and wellness. The company built Lingo on its FreeStyle Libre CGM technology platform.
Lingo, a consumer biowearable, is available for consumers 18 years and older not on insulin. It tracks glucose in real time and provides personal insights and coaching. Abbott designed it to help people build healthy habits, retain their metabolism and improve their overall wellbeing.
(Abbott Diabetes SVP of Commercial Operations Chris Scoggins spoke to Drug Delivery Business News in June and explained the benefits of OTC CGMs. READ HERE)
Insulet pairs Omnipod 5 iPhone app, integrates it with Dexcom G7
Insulet made a massive double-announcement in June when it confirmed the limited rollout of the iPhone app for its Omnipod 5, plus integration with the Dexcom G7.
Omnipod 5, the first FDA-cleared tubeless automated insulin delivery system, communicates with a CGM. It proactively corrects for highs and protects against lows with insulin dosing. The waterproof device features mobile app control for ease of use.
Following the limited release, Insulet commenced a full rollout in October. The app, available for free download from the Apple App Store, allows users to fully control their Omnipod 5 from their compatible iPhone. For example, users can bolus for a meal, change a pump and adjust settings. Additionally, it means Omnipod 5 users with a compatible iPhone no longer need to carry a separate controller device.
Additionally, with the integration with Dexcom’s latest-generation CGM, Omnipod 5 now works with the previous-generation G6 and the latest G7 sensor to offer more choices for people with type 1 diabetes.
A new automated insulin delivery system enters the diabetes tech market
Sequel MedTech made waves in the diabetes tech space when it announced the receipt of FDA clearance for an automated insulin delivery system in March. The company, after all, was co-founded by Dean Kamen, who commercialized the first wearable insulin pump for diabetes.
The twiist system, powered by Tidepool, directly measures the volume and flow of insulin delivered with every microdose. It offers the capability and flexibility to address each patient’s individual dosing needs. Sequel will market the system, which is cleared for people ages six and up with type 1 diabetes.
Sequel designed its twiist AID system to take advantage of FDA medical device interoperability standards. The company says it helps patients better tailor their insulin therapy to their own unique needs. Incorporating Tidepool Loop technology enables automatic adjustments to insulin delivery based on CGM readings and predicted glucose levels.
Speaking to Drug Delivery Business News in June, CEO Dr. Alan Lotvin explained how the Manchester, New Hampshire-based company is looking to carve out its place in the automated insulin delivery space.
Medtronic earns regulatory nod for new CGM paired with insulin delivery tech
The same day Medtronic announced its monumental collaboration with Abbott, the company hit another milestone with its own technology, receiving FDA approval for its Simplera continuous glucose monitor (CGM).
Simplera, the company’s first disposable, all-in-one CGM, comes in at half the size of previous Medtronic CGMs. Its discreet design simplifies the insertion and wear process and eliminates the need for overtape.
Medtronic named its next-generation “Simplera” CGM as a nod to its simplicity. It features a simple, two-step insertion process for people with diabetes using multiple daily injections (MDI). Company officials last fall explained the benefits of the brand new form factor for the medtech giant’s CGM platform.
The medtech giant said FDA approval “lays the groundwork” for a future submission for the updated InPen app. This would facilitate integration with Simplera as a smart MDI system. Once the company garners FDA clearance, it plans for a limited market release in the U.S., beginning with existing standalone CGM and InPen customers.
Senseonics gets FDA green light for year-long CGM
Senseonics announced in September that it received FDA clearance for Eversense 365, its longest-lasting implantable CGM system.
With clearance, Everesense 365 became the world’s first 365-day CGM system. Its indications cover people with type 1 and type 2 diabetes aged 18 years and older. The company launched Eversense 365 in October.
The system also received clearance as an integrated CGM (iCGM) system, meaning it can work with compatible medical devices. Those include insulin pumps as part of automated insulin delivery systems. Senseonics and its global commercial partner Ascensia Diabetes Care have discussions ongoing with various pump manufacturers.
With the sensor resting under the skin, it can not be knocked off, minimizing inconveniences and replacement costs. On the comfort front, users can change its gentle, silicone-based adhesive daily with almost no skin reactions. It offers the freedom to remove the transmitter device without wasting a sensor or adding a warm-up period. Eversense 365 also has on-body vibration alerts for improved discretion, alerting patients even when their mobile phone is out of sight.
(Brian Hansen, Ascensia and Senseonics’ president of CGM, explained the company’s future plans at ADA 2024.)
Former BD Diabetes unit Embecta picks up FDA clearance for insulin patch pump
Embecta joined the patch pump market in September when it received FDA 510(k) clearance for its proprietary disposable insulin delivery system.
The system features a wearable, fully disposable patch pump that provides adjustable basal and bolus insulin for up to three days, depending on the user’s needs. Its 300-unit reservoir specifically caters to the type 2 population, which typically requires higher daily insulin usage. It also has a locked-down controller with Bluetooth wireless technology and a color touchscreen for a simplified user experience.
Embecta says its open-loop system is indicated for adults who require insulin to manage diabetes, including both type 1 and type 2 diabetes. It features a tubeless design with a 300-unit insulin reservoir, informed by feedback from people with type 2 diabetes and healthcare providers. Embecta also has a closed-loop version under development to follow.
Some questions still remain on Embecta after rumors of the company exploring a sale began circulating in July, though.
(CEO Dev Kurdikar spoke to Drug Delivery Business News last year about the opportunities ahead for Embecta. Read here.)
