3 Updates on Diabetes Technology You Don't Want to Miss

Diabetes technology is constantly evolving! Even in between the big conventions like the ATTD and the ADA, there are some new updates you don't want to miss:

1. Libre3 has been approved by the FDA, but with contraindication for closed-loop system
2. Rumors that Dexcom would be acquiring Insulet are wrong
3. MannKind buys V-Go from Zealand Pharma

Want to know what these updates mean for people with diabetes? Then read on quickly.

1. Libre3 was approved by the FDA, but contraindicated for closed-loop system

On May 31, 2022, Libre3 was approved by the FDA for people with diabetes as young as 4 years old, and commercialization in America is expected to start already. It will be offered at the same price as the Libre2, which is 60 dollars per sensor in America (= 56.11 euros). Libre3 has already had a CE label since the beginning of 2022, and is also sold on Abbott's French and German websites at the same price as the Libre2 (in Europe that is 59.9 euros). It is also available in the Netherlands, but only if you qualify for CGM. We hope to get this for Belgium as soon as possible.😍

Abbott has been the market leader in CGMs for years, partly because their Libresensor is by far the cheapest option. There are currently almost 4 million people who wear a Libresensor. The Libre3 is the smallest and possibly most accurate CGM on the market (see also my previous blog post). It has the longest weartime(14 days), and it also has the furthest reach. According to the manual, the data is sent to your mobile phone up to 10 meters away. (With Dexcom G6 and Guardian Connect there is data transmission up to 6 meters away.) A disadvantage is that there will no longer be a reader available, which in practice will be a barrier for a number of people who are now used to using the reader. There are also no predictive alarms available with Libre.

Please note, the FDA approval of the Libre3, like the approval of the Libre2, has a contraindication for use in closed-loop systems. The plans for integration into Omnipod 5 and Tandem Control IQ therefore remain on the shelf for the time being. Perhaps integration in American closed-loop systems will be more suitable for the Libre4? This contraindication does not apply in Europe. So in that respect there is no obstacle to the announced development of the Mylife CamAPS FX system with Libre3.

As for the competition:

• the FDA approval of Dexcom G7 is expected after the ADA congress (so next week?);
• FDA approval for the Guardian 4 (and MiniMed 780G) has been postponed to the end of 2022. This summer, Medtronic will file an FDA and CE application for their Simplera CGM;
• the Eversense E3 was approved by the FDA in February. The CE approval of the Eversense E3 is expected in summer 2022. As a reminder, this is an update of the Eversense XL that also lasts 180 days, but only needs 1x/d calibration from day 21 instead of 2x/d. Clinical data from their 365-day sensor will be discussed at this week's ADA.

 2. Rumors of Dexcom Acquiring Insulet Are False

On May 23, 2022, there was a rumor that Dexcom would be acquiring Insulet. This news was disseminated by an anonymous source, and was not confirmed by the firms themselves. It would mean a major shift in the diabetes landscape, and could jeopardize current collaborations.

• What does this mean for the collaboration between Dexcom and other closed-loop systems (Tandem, Diabeloop, Beta Bionics, Cam APS FX)?
• And will Omnipod 5's planned integration with the Libre and Eversense sensor continue?

There was also an impact on the stock price: the share of Insulet went up and that of Dexcom went down.

However, on May 31, 2022 Dexcom responded that there are currently no active talks surrounding an acquisition. Of course this is not a complete denial of a possible partnership in the future... Still interesting how fast things can turn.🤔

Overall, Dexcom and Insulet stocks have not been doing very well in recent months against expectations. Don't ask me why this is, I think those companies are doing very well and I believe in their increasing dominance in the diabetes market.

3. MannKind buys V-Go from Zealand Pharma

V-Go is a mechanical patch pump that was developed for people with type 2 diabetes. There is no battery in it, but works with mechanical energy (with a spring). Nothing should or can be programmed. A V-Go gives a fixed amount of basal insulin (20, 30 or 40 E per hour), and there is a bolus button with which you can give 2 U per click. It is intended to be replaced bij a new V-Go every day. V-Go was developed in 2010 by Valeritas. In 2020, after Valeritas went bankrupt, it was bought by Zealand Pharma for $23 million, and is now (May 17, 2022) bought by MannKind for $10 million. Wondering whether it will be possible to successfully market the V-Go this time...

Here's a comparison with other mechanical insulin pumps from the "Diabetes Technology 2022 Overview" that you can download at diabetotech.com:

This way you are completely up to date with the most important updates about diabetes technology!

The ADA congress is taking place in New Orleans and virtually from 3 to 7 June. As usual, it is full of news, and just like last year, you can also expect an update via this channel.

See you soon,