10 updates about diabetes technology

There's been a lot of movement in the world of diabetes technology lately.

Don't worry, I've got you covered!

I've put together the 10 most important updates here for you:

1. Ypsomed launched mylife CamAPS FX (3/22/2022)
2. Dexcom G7 received CE label (3/14/2022)
3. Libre3 launched in UK (3/15/2022).
4. Omnipod 5 applied for a CE label (2/23/2022)
5. Medtronic partnered with Rockley Photonics (3/10/2022)
6. Phone bolus function for Tandem pump received FDA label (2/16/2022)
7. Eversense E3 received FDA label (2/11/2022)
8. MODD1: Modular Medical's new insulin pump (3/15/2022)
9. New closed-loop data published in NEJM and Lancet
10. Baqsimi will be reimbursed from 4/1/2022 in Belgium

1. Ypsomed launches mylife CamAPS FX

Ypsomed announced on 3/22/2022 that they will partner with CamAPS FX to bring their first closed-loop system to market. CamAPS FX is an android app with the algorithm of a self-learning hybrid closed-loop system, based on data from the Dexcom G6. Cam APS Fx has a CE label and can be used from the age of 1 year and also in pregnancy!

Here you can see again the main differences from the other closed-loop systems:

Ypsomed would launch their "mylife CamAPS FX" closed-loop system in the first half of 2022, starting with Germany, followed by UK, the Netherlands, Switzerland and Austria before the summer of 2022, followed by Scandinavia, Italy, Spain, Eastern Europe and France after the summer. There are no plans for Belgium for the time being😥. The CamAPS FX app is offered free of charge to mylife YpsoPump users. YpsoPump will do the marketing and will pay a license per user to CamDiab.

In America, Lilly has exclusive rights to sell the YpsoPump. Lilly is developing its own algorithm with the Ypsomed pump and Dexcom G6. The mylife CamAPS FX closed-loop system will not become available in America.

The YpsoPump is a small and beautiful catheter pump, with distinctive icons on a touch screen. It works with prefilled insulin "PumpCarts," and the accompanying YpsoPump Orbit infusion sets can rotate 360 degrees.

Ypsomed, meanwhile, is also developing their own "mylife Loop" closed-loop system where the same algorithm as Control IQ will be used (typeZero). This is being developed in several steps:

-The mylife App is already available for android and iOS, but is only a tracking app on which you can see both your pump data and the data from a linked Dexcom G6.

-The mylife Dose app is an app that will also allow you to give a bolus from your cell phone

-The mylife Loop app will then finally be a hybrid closed-loop app.

2. Dexcom G7 has received a CE label.

Dexcom G7 received a CE label on 3/17/2022, and will be rolled out in the coming weeks. However, it is unclear where and on what scale. In the presentation of the last quarterly results (2/10/2022) they said they were going to roll out in 1 area first, then the larger countries, and only then the smaller countries. It seems that in Belgium (and the Netherlands) we will have to wait until 2023. It is also unclear at what price Dexcom G7 will be sold. Previously it was said that it would be much cheaper than the Dexcom G6, but this is no longer mentioned.

Dexcom G7 was submitted to the FDA in late 2021, and an FDA label is expected this year. This is important to us because Tandem Control IQ has promised to provide integration with Dexcom G7 within the month of the Dexcom G7 being approved by the FDA. Also Omnipod 5 has promised to provide integration with the Dexcom G7 (just as they will do with the Libresensor once it is approved by the FDA for use in a closed-loop system). Diabelooop and CamAPS FX have not yet commented on possible integration with Dexcom G7 in the future.

The main features of the Dexcom G7 are that it is 60% smaller than the Dexcom G6, and only has a warm-up time of 30 minutes instead of 2 hours! This is really a great value for patients who depend on their CGM data to make decisions about their food, exercise and insulin.

Other features of the Dexcom G7 include:

• Accuracy is said to be even better than the Dexcom G6 (MARD 8.2% on upper arm and 9.1% on abdomen).
• It is a sensor and transmitter all-in-one, the new applicator is smaller (less plastic) and was adapted so that it can also be used with only one hand
• It lasts 10 days, and there is 12 hours extra time to place a new sensor ("12-hour grace period").
• The new app now also integrates AGP profiles with Time In Range data (which was previously only available in the Clarity app).
• The alarms can be silenced, even the urgent low alarm (a notification is always sent to the app).
• There is also a new receiver, although this is not often used in Belgium.

For the future, they are working on a direct to Apple Watch possibility (cfr now you always have to have your cell phone with you to be able to see your glycemic data on your smartwatch), an update of the CGM algorithm (with possibly even better accuracy), and a 15-day lifetime. Although there was once talk of this, there is no accelerometer in the Dexcom G7 and this is not planned (anymore), idem for inclusion of monitoring of other metabolites like lactate and ketones.

Finally, Dexcom is also working on:

• a Dexcom Hospital CGM System, for which it received an FDA Breakthrough Device Designation on 3/1/2022 (it is not yet clear what this system will look like)
• Further rollout of Dexcom ONE in countries where Dexcom is not yet present. This cheaper version of the Dexcom G6 has no connection to a pump and no follow function. It is currently rolled out in Bulgaria, Estonia, Latvia and Lithuania.

3. Libre3 launch in UK.

Libre3 was launched in Germany in 2021, and has been available in the Netherlands since 12-2021. At the presentation of the last quarterly results (1/26/2022), the CEO, Robert Ford, said that they were going to launch in France and UK in the next few weeks. Since 3/15/2022 Libre3 is available in UK through NHS for people eligible for rtCGM (people with type 1 diabetes and people with type 2 diabetes at risk of hypoglycemia or unstable glycemic control).  

The FDA label for Libre3 as an iCGM was requested in 2021. The required accuracy study should have happened, but the results have yet to be published.

For the future, Abbott is working on:

• the Lingo which will measure not only glucose but also lactate, ketones and alcohol (cfr my previous blogpost). At the end of this year we should expect the Lingo Keto in Europe.
• And the Libre4! Although we don't know what that one will entail, I'm curious 🤔

4. Omnipod 5 has applied for a CE label.

At the presentation of the last quarterly results (2/23/2022), Shacey Petrovic, the CEO of Insulet, told us that the Omnipod 5 has applied for a CE label. This is very good news! Normally a CE label takes 6 months, but because of the Brexit the procedure has changed, so it could take longer. (In this interview from 3/17/2022 she tells more about it.) So in the best case we will have the Omnipod 5 available in Europe this year, in the worst case it will take 1-2 more years. And then, of course, it will also depend on the regional reimbursement (of Omnipod 5 as well as Dexcom G6) whether this really reaches the patients.

Omnipod 5, meanwhile, is rolling out in America. The intention is that within a few months people who use the Omnipod DASH will be able to switch to Omnipod 5 themselves via an online training course. This is very ambitious since most patients have a lot of questions when switching to a closed-loop system.

If you want to read more about the unique points of Omnipod 5, be sure to check out my previous blog post.

5. Medtronic to partner with Rockley Photonics (announcement 3/10/2022).

Rockley Photonics is developing a smartwatch that non-invasively measures several metabolites at once, namely heart rate, respiration rate, oxygen stabilization, body temperature, hydration, alcohol, lactate and glycemia (not ketones). It is not clear in what way Medtronic plans to use this smartwatch. Integrating this data into a closed-loop system could theoretically yield better results, though.

Meanwhile, Medtronic has been waiting a while for an FDA label for the MiniMed 780G and Guardian 4, possibly delayed by the warning Medtronic received from the FDA in December 2021 for inadequate quality control at their California plant.

The FDA application of Simplera (the successor to the Guardian 4) is scheduled for late April 2022. During the last presentation of their quarterly results (2/22/2022), it was also reiterated that Medtronic is still working on their own patch pump.

6. Phone bolus for Tandem pump is approved by FDA

The "phone-bolus" feature for the Tandem pump was approved by the FDA on 16/2/2022. In America, the t:connect app is used by >160 000 people to track the data of their Tandem t:slim X2 insulin pump on their cell phone. With this new feature, you can give a bolus from your cell phone, so you don't have to take your pump out from under your clothes to do so. The function will be launched this spring-summer in America, but will initially only be available for newer cell phones (iPhone 12 and Samsung Galaxy S20). It does require a (free) update to Tandem Pump and the t:connect app. It is the first step towards full "phone-control" of Tandem insulin pumps.

7. Eversense E3 is approved by the FDA.

The Eversense 180-day was approved by the FDA on 2/11/2022. Currently, only the Eversense 90-day (America) and Eversense XL (Europe) are available. The new version now approved by the FDA (from 18 years) will be called Eversense E3. It will be commercialized by Ascencia starting in the 2nd half of this year.

A CE label is expected in the 3rd quarter of this year. It will only need to be calibrated 1x/d from day 21. (The Eversense XL also lasts 180 days, but must be calibrated 2x/d.) It has a very good accuracy: MARD 8.5%. A known advantage of this sensor is that you have the possibility to temporarily remove your transmitter from your arm, and it can also give a vibration alarm instead of an audible alarm.

8. MODD1 is a new insulin pump from Modular Medical

Modular Medical went public on 2/10/2022, and gave an Investor Presentation on 3/15/2022. This company was founded by Paul DiPerma, the founder of Tandem Diabetes and developer of the t:slim pump. Its advisory board includes such resounding names as Prof. Bruce Bode and Lutz Heinemann.

They are developing the MODD1: an insulin pump that they are going to submit to the FDA in the 2nd quarter of 2022, and plan to launch in 2023. This pump is a modular semi-patch pump, with the top "pump" piece lasting 3 months. The infusion set and pump base must be replaced every 3 days. The reservoir and a cell battery are located on the pump base. It is initially only monitored with your cell phone and controlled with the bolus button on the pump. There is no separate remote control. The direct successor, the MODD1+, is controlled with the cell phone. They are deliberately open to open source software.

The MODD1 stands out because it is a very simple pump, and it will be affordable enough to make it a mass product.

"Modular Medical, Inc. (NASDAQ:MODD) intends to launch the first next generation of insulin delivery technology that will be both affordable and simple enough to learn and use to transform the insulin pump market into a mass market."

In just 1 hour you would know the whole system. For patients, the onboarding can even be done through an app. It is the only patch pump with 300 E of insulin. Finally, it would provide a more continuous insulin delivery instead of standard microboluses every 5 minutes and also work with the latest ultra-fast insulins (Fiasp and Lyumyev, that is).

The components of the pump would be 50% cheaper, which is why they want to give insurers a 20% discount compared to Omnipod, in the hope of getting a preferential treatment. Their official pricing is identical to Omnipod's, but on their investor presentation of 3/15/2022 they mention that they have a 75% profit on this... Well, hopefully they can convince investors with this, which in turn can help to get the product on the market faster.

They are also working on a MODD2: a bihormonal completely closed-loop system that no longer requires patient interaction. Unlike iLet and Inreda, they choose to combine it with pramlintide (Symlin) instead of Glucagon. By offering the MODD2 prefilled, they also hope to make a profit on the insulin and pramlintide.

Furthermore, they also show what the Omnipod looks like on the inside, I hadn't seen that yet 💡

9. New closed-loop data

✨ CamAPS FX in very young children (publication NEJM 1/20/2022): in 74 children, 1-7 years old, with a baseline HbA1c of 7.3%, a 16-week period of closed-loop was compared with a 16-week period with the same insulin pump and sensor but without the auto mode or vice versa: TIR averaged 72% in closed-loop and 63% in open-loop. TBR (here <63 mg/dl instead of <70 mg/dl) remained stable at 2.4 to 2.6%.

✨ CamAPS FX in adolescents (publication Lancet Digital Health 3/7/2022): 133 adolescents, 6-18 years old, with a baseline HbA1c of 8.2à8.3%, were randomized to a closed-loop or control group for 6 months. In the closed-loop group, 2 configurations were used: the earlier FlorenceM system (MiniMed 640G pump, Guardian 3 sensor and algorithm on a locked android phone) and the newer CamAPS FX system. (In the control group, TIR remained stable at 50% as expected, TBR did drop from 8.7% to 6.3%). In the CamAPS FX system (which was used in 21 patients), the TIR increased from 50% to 63%, however, the TBR increased from 8.6% to 10.8% (this was not significant). The TBR here is based on a LibrePRO sensor, when checked with the Dexcom G6 sensor the TBR was only 2.8%. Apparently Libre1 gave a lot of false hypoglycemias (!). With the FlorenceM system the results were not as good, but this was because of a low time in auto mode due to connectivity problems.

✨ CamAPS FX in the elderly (publication Lancet Healthy Longevity March 2022): in 38 adults, >60 years old, with a baseline HbA1c of 7.4%, a 16-week period of closed-loop was compared to a 16-week period with the same insulin pump and sensor but without the auto mode or vice versa: TIR averaged 80% in closed-loop and 71% in open-loop. TBR remained stable at 1.6 to 1.8%.

✨ Diabetic DBL4K in adolescents (Lancet Digital Health publication March 2022): in 21 children, 6-12 years old, with a baseline HbA1c of 7.0à7.6%, a 6-week closed-loop period was compared with a 6-week period with an insulin pump and sensor but without auto mode or vice versa: TIR was on average 66% in closed-loop and 59% in open-loop. TBR was 2.2% in closed-loop and 4.4% in open-loop. This study used a Kaleido pump, Dexcom G6 and a Diabeloop algorithm adapted for children (DBL4K instead of DBLG1).

It is clear that the results in adolescents are systematically poorer. I suppose this is due to puberty, in which you probably have different priorities than your diabetes.

10. Baqsimi will be reimbursed from 1-4-2022 in Belgium

It's not really a CGM or an insulin pump, but it's still an important advance for people with type 1 diabetes! How hard can using the regular Glucagon Hypokit be? In stressful situations like a hypoglycemic coma, you can miss so many extra steps!

Baqsimi is glucagon that can be administered nasally, even to someone who is unconscious (so you don't have to "snort" this). Just inject it once in 1 nostril. You don't have to keep it in the fridge either, so it's extra easy to take with you when you travel.

As of 4/1/2022, any doctor can prescribe this for a patient with diabetes in Belgium. There is no additional certificate needed. For the Netherlands, I don't know if this is reimbursed? If someone knows this, you can always put it in the comments 😀

Diabetes technology is advancing rapidly, which makes it difficult to stay uptodate. In this blog post, I've gone over the main developments of the last few weeks. Are there any updates that stand out in your opinion? Let me know what you think about them!

Kind regards,