Diabetes Tech Highlights: JP Morgan Healthcare Conference 2024

As the year kicks off, the world of diabetes technology is already buzzing with exciting developments. The recently concluded JP Morgan Healthcare Conference, held from January 8th to 11th, 2024, shed light on some promising breakthroughs in the field. In this comprehensive blog, we'll delve into every detail of what's been happening.

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1. The Power of CGM and GLP-1 Analogs
2. Expected Upgrades on Dexcom G7/ONE
3. Introducing the 15-day Dexcom Stelo Sensor for ype 2 Diabetes (Jan 8, 2024)
4. Tandem Control-IQ and FreeStyle Libre 2 "Plus" Integration (Jan 8, 2024)
5. Possible Omnipod 5 - FreeStyle Libre 2 Integration in the Netherlands and UK
6. Medtronic's MiniMed 780G with Simplera Sync receives CE Label (Jan 8, 2024)
7. FDA Submission for Embecta's New Insulin Patch Pump for Type 2 Diabetes (Jan 9, 2024)
8. FDA Submission for?PharmaSens' Niia Essential Insulin Patch Pump (Dec 29, 2024)

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#1 The Power of CGM and GLP-1 Analogs

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For individuals dealing with type 2 diabetes, a persistent question has revolved around the reimbursement of Continuous Glucose Monitoring (CGM) in addition to the crucial GLP-1 analogs and SGLT2-inhibitors. However, during the conference's Dexcom presentation, a compelling vision was unveiled.

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Mr Kevin Sayer (CEO Dexcom) presented a real-life case of a newly diagnosed?56-year old female with type 2 diabetes?who simultaneously commenced treatment with GLP-1 analogs, SGLT-2 inhibitors, and CGM.

He showcased how this patient transitioned from spending 50% of their?Time In Range (TIR) to an impressive 100% TIR, eventually discontinuing both GLP-1 and SGLT-2 therapy.

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This presentation sparked a thought-provoking question:

"Could this become a reality for all individuals with type 2 diabetes?"

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While this approach may not be the most cost-effective option for government healthcare systems, it opens up new possibilities for those willing to invest in their health.

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Furthermore, Dexcom's data indicated that incorporating CGM alongside a GLP-1 agonist led to even greater improvements in HbA1c levels

According to US payer data, individuals with type 2 diabetes and an HbA1c level above 8%:

• using both CGM and GLP-1 (n=1,562), experienced a more significant reduction in A1c (-1.47%)
• than those solely on GLP-1 therapy (n=5,40; HbA1c reduction -0.99%).?

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Additionally, the initiation rate of CGM among non-insulin-dependent type 2 diabetes patients was higher among those using GLP1 agonists.

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In conclusion, Dexcom suggests that individuals are already embracing the strategy of adding CGM to their GLP-1 treatment,

indicating that the enthusiasm for GLP-1 therapies won't hinder the growth of Dexcom or other CGM companies.

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#2 Expected Upgrades on Dexcom G7/ONE

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Dexcom is at the forefront of innovation in continuous glucose monitoring.

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They are actively working on extending the wear-time of their G7 series from 10 to 15 days, although this upgrade won't be available in 2024 due to ongoing accuracy improvements.

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For 2024, the Dexcom team is committed to enhancing the user experience:

• Smart insulin pens will directly connect to the Clarity app?(which is integrated into the Dexcom ONE and Dexcom G7 apps).
• Health-related data from devices such as the Oura Ring and Apple Health will seamlessly integrate with Clarity.
• Dexcom G7's direct-to-watch feature for Apple Watch is submitted for FDA label, offering users real-time CGM data on their wrists.
• And in the first quarter of 2024, Dexcom will transition the Dexcom ONE to the G7 form factor.

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#3 Introducing the Dexcom Stelo Sensor

Dexcom has exciting plans for the Stelo sensor, designed specifically for individuals not on insulin.

• This sensor, featuring the G7 form factor and a 15-day wear-time, is expected to launch in the upcoming summer.
• Dexcom has tailored software specific for this user population.

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At the JPM conference, it was implied that the sensor would be priced in par with the FreeStyle Libre / Lingo sensor.

• Initially, individuals with diabetes can opt for a cash-pay model to access these sensors.
• However, Dexcom aims to secure reimbursement over time by generating supporting evidence.

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This move is a significant step towards making cutting-edge technology accessible to a broader audience.

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Dexcom concluded with a "where we are (going)" slide filled with ambition and inspiration, offering a glimpse of both the present achievements and the exciting prospects on the horizon.

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It's a vision that fuels dreams of broader accessibility and improved healthcare. ??

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#4 Tandem Control-IQ and FreeStyle Libre 2 "Plus" Integration

Tandem's Control-IQ technology now seamlessly connects with the new 15-day FreeStyle Libre 2 "Plus" sensor, available exclusively in the US (see press release Jan 8, 2024).

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Users of Tandem Control-IQ technology in the US can now update their pumps to software version 7.8, enabling this integration.

It's important to note that a compatible smartphone and the t:connect Mobile App are prerequisites for using the FreeStyle Libre 2 Plus sensor with the t:slim X2 insulin pump.

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After scanning the FreeStyle Libre 2 Plus sensor with the Tandem Mobile app:

• the FreeStyle Libre 2 Plus sensor sends readings to your t:slim X2 insulin pump every 1 minute,?
• and Control-IQ technology adjusts insulin delivery every 5 minutes.

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The new FreeStyle Libre 2 Plus sensor offers several advantages compared to Dexcom:

• Sensor warm-up time is only one hour.
• And the sensor has a 15-day lifespan, so you only need 2 sensors per month.
• Unfortunately, for the first 12 hours, the sensor cannot be used for treatment decisions, necessitating mandatory finger pricks for mealtime insulin dosing or manual corrections if needed.

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The cost of the FreeStyle Libre 2 Plus sensor is expected to be in line with the standard FreeStyle Libre 2 sensor.

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While there are plans to integrate FreeStyle Libre 3 in the future, the exact timeline remains uncertain.

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It's important to note that Europe?does not and may never have access to the 15-day FreeStyle Libre 2 Plus Sensor, as integration with FreeStyle Libre 3 is prioritized.

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#5 Possible Omnipod 5 - FreeStyle Libre 2 Integration in the Netherlands and UK

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At the JPM conference, dr. Jim Holllingshead, CEO of Insulet, reinforced the company's strategic plans for 2024.

After successfully launching the Omnipod 5 in the UK and Germany, Insulet is gearing up to expand its presence in additional European markets,

with the goal of making the Omnipod 5 accessible to "the majority" of its European customers by the end of 2024.

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Insulet also announced its intention to integrate the FreeStyle Libre 2 sensor with the Omnipod 5, targeting select European countries for this integration during the first half of 2024,

with the UK and the Netherlands being among the initial locations.

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While Dr. Hollingshead hinted at the potential integration of FreeStyle Libre 3, specific timelines were not disclosed.

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Furthermore, there's exciting news on the horizon,

• as a limited market release for the Omnipod 5 with Dexcom G7 integration is anticipated for this quarter.
• Additionally, the Omnipod 5 iOS app is on track for an early release "early this year".

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#6 CE-approval for Medtronic's MiniMed 780G with Simplera Sync CGM

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Medtronic has received CE-approval for its next-gen CGM, Simplera Sync, when integrated with the 780G system (see press release Jan 8, 2024).

The sensor, previously referred to as Instinct CGM, now boasts a more intuitive name, Simplera Sync.

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This development is particularly significant for users of the MiniMed 780G in Europe, as it brings us closer to the commercialization of the new Simplera Sync CGM.

• The Simplera sensor is 50% smaller than the Guardian 4 sensor
• and features an easier one-click application process
• for the sensor and transmitter, combined into one device.

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#7 FDA Submission for?Embecta's New Insulin Patch Pump for Type 2 Diabetes

Embecta has submitted its insulin patch pump for people with type 2 diabetes to the FDA (see press release Jan 9, 2024), and provided additional insights into this innovative product.

Some key details include:

• The pump can hold more than 200 units of insulin in its reservoir.
• It is fully disposable and a picture was shared during their presentation.
• And the pump offers a 3-day wear-time.

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Embecta is not only working on an open-loop system but is also collaborating with Tidepool to create a closed-loop system.

• The first study involving the Loop algorithm and Dexcom sensor has concluded (NCT05951569), but the system still requires a Riley link.
• The team is actively working on integrating the Loop algorithm into the new Embecta pump.

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#8?FDA Submission for?PharmaSens' Niia Essential insulin patch pump

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Although not announced on the JP Morgan conference, PharmaSens also recently submitted its Niia Essential insulin patch pump system?to the FDA (see press release Dec 29, 2023),

and plans to pursue CE-marking in the near future.

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Niia Essential represents the first of PharmaSens' three patch pumps and has been designed to be easy to learn and easy to use.?

• It has a dedicated filling aid for easy refilling
• and the ability to administer boluses directly through the pump without requiring additional screens.

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Configuration of bolus amounts and basal insulin delivery is facilitated through the niia essential Configuration app?on your smartphone or tablet via Bluetooth.

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The niia pumps follow a modular approach:

• The reusable part includes the pump and CGM electronics and lasts for 2 years.
• The disposable?part holds a 3 ml pump reservoir,?cannula and on-body patch.
• Additionally, the device incorporates an automatic needle insertion mechanism to ensure the safety of the 90° steel needle before each use.

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According to the company's website,

• Niia Advanced will offer compatibility with a Continuous Glucose Monitoring (CGM) system and will be controlled via a smartphone.
• On the other hand, Niia Signature will be an all-in-one patch pump with integrated CGM capabilities.

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Conclusion: A Bright Future for Diabetes Care

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These updates paint a promising picture of the future of diabetes care.

The continuous evolution of technology offers hope to individuals managing diabetes and healthcare providers striving to improve patient outcomes.

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As we step into 2024, let's keep our eyes peeled for further advancements in this rapidly evolving field.

Exciting times lie ahead!

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If you're eager to get a comprehensive overview of the current and future CGMs, insulin pumps, and AID systems,

don't forget to download our "Complete Overview of Diabetes Technology 2024."?

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This comprehensive resource will provide quick insights into the vast potential of this market and prepare you for what's on the horizon. ??

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Click here for the version for healthcare providers,

and here for the version for people with diabetes.

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Kind regards,

Inge