Read on to discover all the details!

1. Diabeloop-Kaleidolaunched in the Netherlands, France and Germany (21-11-2023)
2. FDA label for Tandem Control-IQ in children aged 2 years and older (7-11-2023)
3. Limited launch in the US: Tandem Control-IQ with Dexcom G7 and the Mobi pump (17-11-2023)
4. FDA label for Omnipod 5 iOS app (23-10-2023)
5. New version AndroidAPS app (23-10-2023)
6. The iLet insulin-only from Beta Bionics is available through pharmacies in the US (15-11-2023)
7. CE mark for GS1 from Sibionics (1-11-2023)
8. Warm-up time of Medtronics' Simplera CGM remains 2 hours (14-11-2023)

9. Pacific Diabetes Technologies is working on a combined sensor and patch pump (3-11-2023)

From 21 November 2023 a new AID combination is available: Diabeloop with the Kaleido pump.

This promising combination is now available to patients in The Netherlands, France and Germany,

and there are plans to also launch it in the United Kingdom and Italy in 2024. 

This advanced closed-loop system consists of three main components:

1. An updated DBLG1 handset with the integrated DBLG1 algorithm.
   • Remarkably, the updated DBLG1 handset is now white instead of black, and is significantly smaller and lighter than its predecessor.

2. The Kaleido pump.
   • The Kaleido pump is known for its colourful and modular design. It is more compact and lighter than the Omnipod 5, but can still hold the same amount of insulin (200 units).
   • In addition, the Kaleido pump offers a range of colour options, including orange, red, pink, purple, blue, green, turquoise, grey and black. The choice is up to the patient.
   • In addition, one can choose between tubing of 5 or 30 cm and canulas of 6 or 9 mm.
   • Another plus is that the pump is waterproof to a depth of 1.5 metres for 1 hour.

3. The Dexcom G6 sensor.
   • The Dexcom G6 sensor is a well-known and reliable sensor that is an integral part of this system.

The DBLG1 algorithm, previously approved for adults with type 1 diabetes aged 18 and over, remains the core of this AID system.

Data are automatically forwarded to YourLoops via a built-in SIM card on the DBLG1 handset.

Recent real-world results with the DBLG1 algorithm among 3706 users from Germany show an average TIR (Time in Range) of 72% and TBR (Time Below Range) of 0.9%, which are comparable results compared to other AID systems.

After a temporary period when Diabeloop was not available due to the discontinuation of the Accu-Chek Insight insulin pump, Diabeloop is now back in the diabetes care arena.

This gives people with type 1 diabetes more options and now gives them a choice between not 1 but 2 AID systems with a patch pump, at least in the Netherlands, Germany and France.

2. FDA label for Tandem Control IQ in children aged 2 years and over

On November 7, 2023, the FDA gave the green light for the use of Tandem Control-IQ in children as young as 2 years old, based on the results of the PEDAP trial.

This is an important step forward in the treatment of young diabetes patients.

It is currently not yet clear when we can expect a CE label for the use of Tandem Control IQ in very young children. 

Nevertheless, this approval marks Tandem Control-IQ as the fourth officially approved closed-loop system for very young children (from 2 years of age),

• in addition to CamAPS FX (CE label only),
• Omnipod 5 (CE and FDA label)
• and the older MiniMed 670G (CE and FDA labelled).

It is also worth noting that there are plans to apply for an FDA label for the use of MiniMed 780G in children aged 2-6 years old.

This approval, however, is subject to the results of the LENNY study, which is currently underway and the results of which are expected in May 2024. 

3. US limited launch: Tandem Control-IQ with Dexcom G7 and the Mobi pump

In the middle of November, a limited launch took place of the integration of the Dexcom G7 with Tandem Control-IQ for a select group of users in the United States.

A full rollout in the US is expected by the end of the year, followed by availability in other countries.

To take advantage of the Dexcom G7 integration, a free software update to version 7.7 of the pump is required.

Within the next few weeks, the integration of Tandem Control-IQ technology with the FreeStyle Libre2 will also be launched for a select group of users in the US.

In 2024, work will continue on integration with the FreeStyle Libre3 for countries outside the United States.

After October 2023, a limited group of people in the United States also started using the Mobi pump.

The full commercial launch of the Mobi pump in the United States is scheduled for early 2024.

No timeline has yet been announced for the European launch, but we hope it will take place by the end of 2024.

In addition, Tandem Source, Tandem's new readout platform, is now available to all healthcare providers in the United States.

However, it is still unclear when this platform will be rolled out to countries outside the US.

4. FDA label for Omnipod 5 iOS app

On 23 October 2023, the FDA approved the iOS version of the Omnipod 5 app.

The iOS app is expected to be made available in early 2024, initially in the United States.

It is not yet known when this app will be available in Europe.

The app not only introduces a slightly modified interface,

but also a "custom food feature" (custom food function).

This feature allows users to save the carbohydrate portions for their favourite meals or snacks,

allowing them to select and register them faster in the future.

5. New version AndroidAPS

A new version of AndroidAPS has been available since 23 October 2023,

and you can find an overview of the novelties at this page.

One notable addition is that you can now also TidePool be used as a readout platform. 

• In many ways, this can be more convenient than Nightscout because you don't have to build it yourself. 
• Tidepool is a free open-source platform. 
• However, it is important to note that, like AndroidAPS and Nightscout, Tidepool does not have an FDA or CE label. Its use is therefore at your own risk.

With regard to compatibility with insulin pumps, you could previously pair the Omnipod DASH, Accu-Check Insight, Accu-Check Combo, Dana pumps and older Medtronic pumps.

Now the EoPatch2 and the TouchCare Nano pump have also been added to the list of supported pumps. 

Before glycemia sensors it was already possible to link Dexcom, FreeStyle Libre sensors, Eversense and Enlite sensors.

Now also added the Glunovo sensor, as well as the Dexcom G7.

As icing on the cake, this new version is introduced with a new logo!

It is clear that open source developers remain active and it is admirable how they are keeping up with and even ahead of technological advances at a rapid pace.

6. Beta Bionics' iLet insulin-only is available through pharmacies in the US

On 15 November 2023, Beta Bionics announced that their iLet insulin-only system will become available to US patients through a subscription model at local pharmacies.

This means that the initial cost for this AID system will be significantly reduced for these patients, lowering the threshold to start using it.

This is a remarkable milestone, as it is the first time a tubed pump has been marketed in this way.

Although the Omnipod 5 is also available through pharmacies in America, it should be noted that this is a patch pump, which usually comes with much lower start-up costs.

It remains to be seen whether this financing model will catch on in Europe,

but it is clear that it is effective in America and will result in wider accessibility to the Beta Bionics iLet system there.

7. CE label for GS1 from Sibionics

On 1 November 2023 Chinese company Sibionics has received CE label for its GS1 CGM system.

Remarkably, this glucose sensor is already used in China by as many as 600,000 people with diabetes!

This would make Sibionics the 3rd largest CGM provider globally (after Abbott and Dexcom).

The GS1 is a sensor that can be worn on the skin for 14 days and is said to have an impressive MARD (Mean Absolute Relative Difference) of 8.83% has. 

• This sensor measures blood sugar levels every 5 minutes and sends the data to a SiBinics app available for both Android and iOS. 
• No separate receiver is available. 
• The heating time of the sensor is only 1 hour, 
• and it is waterproof to a depth of 1 metre for 1 hour.

A useful feature is the Share function, which allows family members to view the data.

In addition, AGP (Ambulatory Glucose Profile) reports can be generated in the app, or the data can be uploaded to the ProView remote access platform.

Now it remains to be seen in which European countries the GS1 CGM will become available.

Tom from TypeOneTalks has at least already tested it and was enthusiastic about it, as seen in this video.

8. Warm-up time of Medtronics' Simplera CGM remains 2 hours

On 21 September 2023, Medtronic's new Simplera CGM received a CE label.

Although we initially thought that the warm-up time of this sensor was only going to be 30 minutes, as also mentioned in this manual on the internet,

recently uploaded explainer videos on YouTube show now that the actual warm-up time will be 2 hours after all.

Despite this adjustment, we still look forward to this new sensor!

The version for use with the MiniMed 780G will still retain the name "Instinct" for now. 

• The CE label for this has reportedly already been applied for, and the launch of the Instinct is expected in 2024 in Europe. 
• Currently, there is also a study being conducted with this sensor in 250 people with type 1 diabetes, and an FDA-submission is expected in July 2024.

9. Pacific Diabetes Technologies is working on a combined sensor and patch pump

During the Virtual Diabetes Technology Meeting beginning November 2023, Dr Siedl of Pacific Diabetes Technologies presented

their in-development insulin patch pump with an integrated glucose sensor.

They shared data from the SynerG, their first working device. 

• The glucose sensor has a warm-up time of 30 minutes and requires a single calibration 15 minutes after placement. 
• The Mean Absolute Relative Difference (MARD) value was 9.2% in the first 12 participants.

In 2024, the device will be further explored in the United States.

These promising results raise the hope that we can soon have an integrated patch pump and glucose sensor, ideally with an integrated algorithm.

This brings us another step closer to the long-awaited artificial pancreas, with just one device on the body.

Conclusion

In this blog, we have taken you through the latest and greatest developments in diabetes technology.

From new Automated Insulin Delivery systems to advanced glucose sensors, there is much to look forward to in the world of diabetes care.

What is striking is that technology is becoming increasingly accessible to a wider range of patients, both in terms of age and type of diabetes.

It is encouraging to see how these innovations continue to improve diabetes patient care and enhance quality of life.

Would you like to learn more about these emerging technologies and how they can help you manage diabetes? Then we have good news for you!

The Diabetes Technology Expert Program offers free courses on glucose sensors, insulin pumps and automated insulin delivery systems compiled by experts in the field.

This is an opportunity not to be missed to enhance your knowledge and understanding of diabetes technology.

Enrol in these valuable courses today and invest in your health and well-being. Together, we will work towards a healthier future for everyone living with diabetes. 

▶▶ Click here to register for the free courses of the Diabetes Technology Expert Program. ◀◀◀

Kind regards,

Inge