Study highlights benefits of automated insulin delivery for children in UK

The MiniMed 780G with Guardian 4 and a 7-day infusion set. [Image courtesy of Medtronic]A study in the UK demonstrated significant improvements in HbA1c for users of automated insulin delivery technologies.

This comes on the heels of a UK NHS initiative to provide tens of thousands of children and adults with type 1 diabetes in the country with an artificial pancreas.

The study aimed to assess the efficacy of hybrid closed-loop systems at 12 months. It looked at HbA1c, time in range, hypoglycemia frequency and quality of life measures among children and young people with type 1 diabetes.

Investigators conducted the study between Aug. 1, 2021, and Dec. 10, 2022 across eight pediatric diabetes centers in England. They utilized three automated insulin delivery systems, all fully funded by the NHS:

Tandem t:slim X2 pump with Control IQ technology in combination with the Dexcom G6 CGM. Medtronic MiniMed 780G with Guardian 4. Ypsomed YpsoPump with CamDiab Ca…
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Tandem Diabetes Care prices $275M offering

Tandem Diabetes Care (Nasdaq:TNDM) announced today that it priced an offering of convertible senior notes worth $275 million.

The San Diego-based automated insulin delivery technology developer plans to sell the notes, due 2029, to qualified institutional buyers. It upsized the offering from the previously announced $250 million aggregate principal amount. The company also offered initial purchasers the option to purchase, within the 13-day period following issuance, $41.25 million in additional notes.

Tandem expects the offering to close on March 8, subject to customary closing conditions. Its notes accrue interest, payable semiannually in arrears on March 15 and Sept. 15, of 1.5% per year. They mature on March 15, 2029, unless earlier converted, redeemed or repurchased.

Get the full story at our sister site, Drug Delivery Business News.

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These diabetes devices are set to launch in 2024

The Stelo glucose monitor. [Image courtesy of Dexcom]The diabetes space continues to innovate and it doesn’t look like that’s stopping any time soon, with 2024 set to be another banner year.

At the end of 2023, we compiled a list of the 10 biggest diabetes technology stories of the year. Some of those stories didn’t end in 2023, though, as a few major product launches loom on the horizon.

New CGMs, insulin pumps and combinations of the two will all be coming to the market over the next several months. Here are some of the most highly-anticipated product launches set to take place in the diabetes space in 2024 — plus some of the tech that’s already launched:

Diabetes launches on the horizon Medtronic’s new pump-sensor combo

In January, Medtronic won CE mark for its MiniMed 780G automated insulin delivery system with the Simplera Sync sensor.

The MiniMed 780G with the Simplera Sync CGM and accompanying devices. [Image courtes…
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Tandem stock dips after hours on Q4 misses, 10% growth expected in 2024

Tandem Diabetes Care (Nasdaq:TNDM) shares took a hit after hours on fourth-quarter results that came up short of the consensus forecast.

Shares of TNDM fell 8% at $20.74 apiece after the market closed today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the day up 0.2%.

The San Diego-based automated insulin delivery technology developer posted losses of $30 million in the quarter. That equals 46¢ per share on sales of $196.8 million for the three months ended Dec. 31, 2023. The company’s bottom line fell by nearly 90% while sales dipped by 10.8%.

Compared to Wall Street expectations, earnings per share fell 21¢ shy, while sales came up nearly $6 million short.

Get the full story at our sister site, Drug Delivery Business News.

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Tandem Diabetes Care launches Mobi mini automated insulin patch pump

The Mobi miniature, durable automated insulin patch pump worn on a hiker’s leg. [Image courtesy of Tandem Diabetes Care]Tandem Diabetes Care (Nasdaq:TNDM) announced today that it kicked off the U.S. commercial launch of its Mobi insulin patch pump.

The San Diego–based company says Mobi, which is fully controllable from a mobile app, is the world’s smallest durable automated insulin delivery (AID) system. It received FDA clearance for people with diabetes ages six and up in July 2023.

Tandem said today that it began taking orders and shipping Mobi to eligible U.S. customers.

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.

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The top IVD and diabetes tech stories of 2023

The G7 CGM helps users manage their diabetes. [Image courtesy of Dexcom]Over the course of 2023, the medtech industry produced another impressive year of innovation, with news coming from a variety of spaces.

Chiefly among those were diabetes technologies and in vitro diagnostics (IVDs). We saw regulatory nods, product launches, funds raised and mergers fall apart.

Looking at those two spaces in particular, here are five diabetes and IVD stories that caught our attention in 2023:

5. Cytovale raises $84M Series C for sepsis diagnostic

In November, Cytovale announced that it raised $84 million in a Series C funding round to support its rapid sepsis diagnosis test. Cytovale earmarked funds to support the wider expansion of this testing technology.

The FDA cleared the IntelliSep test, which aids hospital emergency departments and health systems, in January. IntelliSep provides test results in under 10 minutes, offering actionable answers using standard b…

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Abbott integrates FreeStyle Libre 2 Plus into Tandem’s automated insulin pump

t:slim X2 Insulin Pump from Tandem Diabetes Care with Abbott’s Freestyle Libre 2 Plus sensor integration now available in the United States. [Image courtesy of Abbott/Tandem Diabetes Care]Abbott (NYSE: ABT) + and Tandem Diabetes Care (Nasdaq:TNDM) today announced the integration of FreeStyle Libre 2 Plus CGM into the t:slim X2 insulin pump.

This marks the first automated insulin delivery system to integrate the newly available Abbott FreeStyle Libre 2 Plus sensor. The FDA cleared the updated Abbott continuous glucose monitor (CGM) for use with automated insulin delivery in March 2023. For the first time, users of the leading CGM sensor can utilize a hybrid closed-loop system to manage their diabetes.

Integration of these technologies comes shortly after Tandem became the first to integrate with the next-generation Dexcom G7 CGM. The t:slim X2 insulin pump with Control-IQ technology previously worked with the Dexcom G6. Read more

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The 10 biggest diabetes tech stories from 2023

Medtronic, EOFlow, Dexcom, Beta Bionics and Tandem Diabetes Care all contributed some of the biggest diabetes technology stories of 2023.

It was another banner year for diabetes technology, with regulatory approvals, product launches and M&A all playing their part.

Diabetes technology’s impressive 12 months marked a major trend across medtech as a whole, too.

In 2022, the diabetes space saw plenty of progress from some of its biggest names and this past year proved no different. Big hitters like Dexcom, Abbott, Medtronic, Insulet and more all contributed to some of the biggest stories in 2023. External factors — like popular GLP-1 drugs and big tech names looking to enter the space — also made the cut.

Here are 10 of the most intriguing diabetes technology stories from the past 12 months.

Medtronic was set to buy EOFlow — until it wasn’t

The medtech giant made a big splash in the insulin delivery space when it announced its plan to buy South K…

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Tandem Diabetes Care launches diabetes management platform for insulin pump users

This new diabetes management platform for insulin pump users and healthcare providers is now available for all U.S. customers. [Image courtesy of Tandem Diabetes Care]Tandem Diabetes Care (Nasdaq:TNDM) +  announced today that it launched Tandem Source, a diabetes management platform.

The platform, for both insulin pump users and healthcare providers, brings together features of Tandem Diabetes Care’s legacy offerings. It combines t:connect, t:connect HCP and t:connect Portal with new, comprehensive data reporting in one central, scalable platform.

All Tandem pump users and their providers can access Tandem Source in the U.S. The company expects international availability in 2024.

Tandem Source provides access to important therapy data and ways for users to reorder supplies and update pump software. For providers, it offers the tools necessary to seamlessly view critical patient data, identify trends and help p…

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Tandem Diabetes Care launches first automated insulin pump integrated with Dexcom G7 CGM

The t:slim X2 pump with the Dexcom G7 CGM. [Image courtesy of Tandem Diabetes Care and Dexcom]Tandem Diabetes Care (Nasdaq:TNDM) announced today that it launched its updated t:slim X2 insulin pump software with the Dexcom (Nasdaq:DXCM) +  G7.

Integration makes Tandem the first to offer automated insulin delivery with the latest-generation Dexcom continuous glucose monitor (CGM).

The FDA cleared the next-generation Dexcom G7 in December 2022. By February of this year, the company began the U.S. launch of the G7.

However, integration with automated insulin delivery partners, like Tandem, Insulet and Beta Bionics, took a little longer.

Dexcom EVP and COO Jake Leach told Drug Delivery Business News in October that the company anticipated a G7-t:slim X2 launch by the end of the calendar year.

“The Dexcom G7 and t:slim X2 insulin pump integration is the culmination of years of partnership and a shared commit…

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These 11 medical device inventions are the best of 2023, Time magazine says

Time’s best medical device inventions of 2023 include: (clockwise from top left) ViviStim, Coros, Cala kIQ, InVision. [Images courtesy of the companies]

Time magazine recently named 11 medical device inventions among its best inventions of 2023.

The devices highlighted in the ranking ranged from wearables to treat tremor to leadless pacemakers.

Time magazine says it has identified the most impactful ideas, devices and technologies around the world for more than 20 years. The publication says it compiled the list through nominations from its editors and global correspondents, with special attention to certain categories like medical innovations, accessibility, AR/VR, sustainability, wellness and more.

Time then graded each nominee based on a number of key factors that included originality, efficacy, ambition and impact.

This year’s list included 11 devices from startups and major…

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Tandem stock sinks after hours on Q3 misses, lowered guidance

Tandem Diabetes Care (Nasdaq:TNDM) shares took a massive hit after hours today on third-quarter results that missed the consensus forecast.

Shares of TNDM fell nearly 20% at $14.27 apiece after the market closed today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — closed the day up 1.1%.

The San Diego-based automated insulin delivery technology developer posted losses of $32.96 million. That equals 51¢ per share on sales of $185.6 million for the three months ended Sept. 30, 2023.

Tandem recorded a 32.7% bottom-line gain while remaining in the red on a sales decline of 9.3%.

The company’s losses per share fell 17¢ short of Wall Street expectations. Sales also fell shy of the forecast for $192.7 million in revenue.

Shortfalls in performance weren’t entirely unexpected, though. Tandem said last quarter that updates to its portfolio and reduced visibility on sal…

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