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First news of 2023

Feb 10, 2023

Welcome to this blog about diabetes technology and the first news of 2023!

 

In this article we will also discuss the latest products and developments that have recently been introduced during the Diatec Congress.

The Diatec Congress is an annual congress in Berlin where the latest innovations and developments in the field of diabetes technology are introduced and discussed in German.

  • During 3 days (Diatec), several in-depth sessions are organized for healthcare providers,
  • and on the 4th day there is a separate conference day for people with diabetes themselves (T1Day).

 

Here you will find an overview of the most important news from 2023 so far:

  1. DIY Loop 3.0 creates a closed loop with Omnipod DASH and iPhone 1/14/2023
  2. FDA label for Tidepool Loop, tentatively without pump partner (1/24/2023)
  3. First results Mylife Loop with Libre3 (Diatec 2023)
  4. First experiences with GlucoMen Day Pump (Diatec 2023)
  5. Partnering Diabeloop and GlucoMen Day Pump (11-1-2023)
  6. Promotion Omnipod 5 started in Europe (Diatec 2023)
  7. Yuwell promotes MyGuard CT-14 in Europe (Diatec 2023)
  8. Bankruptcy Rockley Photonics (27-1-2023)
  9. Still a reader for the Libre3 (Diatec 2023)
  10. Can ChatGPT create a closed-loop system?

 

Read more below.

 


 

1. DIY Loop 3.0 creates a closed loop with Omnipod DASH and iPhone 1/14/2023

  

On 1/14/2023, version 3.0 of Loop was released (cfr Github, Loopdocs).

Loop is an open-source or do-it-yourself (DIY) algorithm that you can put on your iPhone yourself.

Although not approved by the FDA or European agencies, the use of DIT Loop is considered safe and effective.

  • In a real-world study with 558 people with type 1 diabetes on DIY Loop, the TIR (time-in-range) increased from 67% to 73% after 6 months (Lum et al. DTT 2021). The TBR (time-below-range) remained low and stable (from 2.9% to 2.8%). These results are consistent with other (commercial) closed-loop systems.
  • This international consensus (Braune et al. Lancet 2022) explains that from an ethical point of view open-source closed-loop systems should be supported.
  • And the latest update to the Standards of Care in Diabetes (ElSayed et al. Diabetes Care 2023) once again recommends that healthcare providers support people using open-source closed-loop systems.

 

Connection with Omnipod DASH is now possible

In the previous versions of DIY Loop you could only connect older Medtronic pumps and Omnipod Eros pods.

  • However, these pumps are no longer available in many places (such as in Belgium).
  • In addition, these pumps do not have Bluetooth, so an additional device (Riley link) was necessary to make the connection between your mobile and the pump.

In DIY Loop 3.0 you can make the connection with the Omnipod DASH for the first time, and this without "Riley link".

 

Connection to Libre2 only possible with extra patch

In DIY Loop 3.0 you can make the link with the Dexcom G6 and Dexcom G7.

  • This makes DIY Loop the first closed-loop system with the Dexcom G7.
  • However, the Dexcom G7 is currently only available in the UK, Ireland, Germany, Austria and Hong Kong.

 

Theoretically it is also possible to work with Dexcom ONE and the European Libre2, but this requires some detours.

  • With Dexcom ONE sensors you will still need a Dexcom G6 transmitter or Anubis transmitter to make the link.
  • The European Libre2 requires an additional software installation ("patch").
  • (Connection to the American version of Libre2 is not possible.)

 

Other updates in the algorithm

In addition to the inclusion of the Omnipod DASH, DIY Lopo 3.0 among other things:

  • updated the appearance of the app and made the accompanying texts of the buttons clearer,
  • increased the ease of use of the app (for example, you can now go directly to the pump/sensor screen via the pump/sensor icon on the home screen),
  • the target value is more limited (in the context of safety you can now set this from 87 to 180 mg/dl or 4.8-10 mmol/l),
  • and made available an additional option to deliver a more aggressive manual correction bolus (by giving a temporary basal in open loop).

 

Link with Apple Watch

Like the previous versions, DIY Loop 3.0 links very well with the Apple Watch.

You can not only see your sensor glycemic continuously on your Apple Watch, but also bolus and start/stop an override from your smartwatch.

(An override can be either a temporary target value or an adjusted % of insulin delivery for basal insulin, bolus insulin and insulin correction. You can choose this yourself.)

 

Create the app yourself or via a paid service

To create the app you need a MacBook and an Apple Developer Membership ($100 per year).

You also have to build a Nightscout account, where the free version requires a lot of computer knowledge.

 

Many people will therefore opt for a "Nightscout Service" at a monthly price (5 to 12 dollars per month).

If you choose T1Pal, they can also provide you with a finished Loop app for about $50 a month.

 

#Wearenotwaiting

If you really can't wait for a closed-loop system with a patch pump, DIY Loop 3.0 is an option for the iPhone users among us.

  • However, you will have to build the app yourself and update it regularly, and the necessary software is not completely free.
  • Or you can opt for a paying service, but the question arises whether many people will be willing to pay so much for this.

 

Another option is of course to wait for the commercial systems, such as Omnipod 5 or Diabeloop with a patch pump (cfr infra).

Important advantages of commercial systems are:

  • You are not responsible for every step,
  • The start-up is faster and easier, and is done through your trusted diabetes team,
  • Your healthcare provider will be able to guide you better,
  • And there is a professional customer service that will assist you if you have any questions or problems.

 


 

2. FDA label for Tidepool Loop, no insulin pump partner yet (1/24/2023)

 

Tidepool Loop App for Diabetes Nears FDA Approval

 

Tidepool submitted the DIY Loop algorithm to the FDA in 2020, and it was approved on 1/24/2023 for people with type 1 diabetes from age 6.

This is a huge boost for the #wearennotwaiting community as it marks the first time an open-source algorithm (i.e. DIY Loop) has been submitted and approved by the FDA!

 

Tidepool will make Tidepool Loop app available in iOS App Store

Tidepool will now complete the algorithm as an app that you can download from the iOS App Store, only in America for now.

You will need a prescription from your healthcare provider for this, which should also contain the initial settings.

These settings are quite similar to the settings of a manual insulin pump:

  • Target value
  • Carbohydrate ratio
  • Insulin sensitivity
  • Basal insulin release
  • Maximum basal
  • Maximum bolus

Finally, as a healthcare provider, you must also specify a preset for the target value for sports and before meals. A unique feature of DIY Loop is that many people use a lower pre-meal target instead of bolusing 15 minutes before a meal. That way it is sufficient to bolus just before the meal.

 

Not completely the same as DIY Loop 3.0

Please note: although Tidepool Loop is similar to DIY Loop 3.0, the functionalities in the commercial app will not be completely the same as those in the open-source app.

This is because Tidepool Loop can only offer the functionalities of the version submitted to the FDA in 2020.

 

What will be included is

  • the temporary target value for sports and before meals
  • the ability to enter carbohydrates in the past (in case you forgot)

 

What will not be included is

  • the overrides where you can set a customisable temporary target or % of insulin release
  • the "automatic bolus" feature where you can have the basal insulin partially delivered in the form of a bolus so it works faster

 

However, an application is already being prepared to integrate these last 2 functions into Tidepool Loop as well, since they are very popular with the DIY Loop community.

Clearly, the open-source algorithms will always remain just a step ahead of the commercial and officially approved ones.

 

Link to Apple Watch was approved

What will also be available in Tidepool Loop is the link to the Apple Watch, along with the ability to bolus and set a temporary target for sports/premeal from the Apple Watch.

 

Insulet and Medtronic withdraw

Initially, Tidepool Loop was going to be compatible with an Omnipod pump and a Medtronic Bleutooth pump, and both companies have also invested in Tidepool in the past to make this project possible.

However, they have now made it known that they will not be a commercial partner at the launch.

 

Tidepool says they are in talks with another manufacturer of an integrable insulin pump, but they can't say who this is yet.... exciting :-)

A real pump partner is very important, because the Tidepool Loop app can only be made available if there is also a working integration with an insulin pump.

 

Dexcom remains a partner

As for sensors, Tidepool said they will continue to work with Dexcom, so at launch the Tidepool Loop app will work with Dexcom G6 (and/or G7).

In principle, they are open to any other iCGM, so hopefully other sensors will also be able to be linked in the future.

 

Also Android App planned

Tidepool has already announced that they will try to make the DIY Loop algorithm available in the Android Play Store.

There was no mention of a submission for a CE label.

 


 

3. First results Mylife Loop with Libre3 (Diatec 2023)

 

 

 

Mylife Loop is the first closed-loop system available with the Libre3 sensor, and with an Abbott sensor in general.

It combines the Libre3 with the YpsoPump and the CamAPS algorithm on an Android mobile phone.

 

No significant problems with the first 100 users

This closed-loop system was launched in Germany in November and the results seem to be good.

At the Diatec conference in Berlin at the end of January, the representatives of Ypsomed said that the reactions are positive and the start-ups are going smoothly.

There was also a patient who was able to confirm this.

 

Similar onboarding

In the Mylife CamAPS app itself you can easily choose between the Dexcom G6 and Libre3.

For the rest, the start-up is completely similar to the Mylife Loop with Dexcom G6.

 

Reading data only with Diasend...

At the moment you can only read the data with the "older" Diasend.

However, most hospitals have switched to Glooko, which may prevent them from tracking their patients in real time.

Patients can, however, create a PDF report themselves in the Mylife CamAPS app and email it to their healthcare provider.

 

...so that there is little insight into glycemic results for the time being

Since the sensor data does not end up with Ypsomed, they could not tell what the glycemic results were with the Libre3 sensor compared to the Dexcom G6 sensor.

 

I hope we learn more about this soon because

  • in America, the Libre2 and Libre3 sensor are still not approved for use in a closed-loop system, despite the very good accuracy data,
  • and it is sometimes noted that Libre sensors give more false low sensor readings compared to the Dexcom sensors.

 

Maybe we'll find out more at the ATTD?

 

 


 

4. First experiences with GlucoMen Day Pump (Diatec 2023)

 

 

The GlucoMen Day Pump has been available in Germany for several months and recently also in the Netherlands and Belgium.

So this is the EoPatch insulin pump from Eoflow, which is distributed in Europe by Menarini.

 

This insulin patch pump is similar to the Omnipod DASH. The main differences are:

  • The pump lasts 3.5 days instead of 3 days.
  • The pump can be controlled with the ADM or with the Narsha App from your mobile phone.
  • The pump is watertight for 24 hours instead of 1 hour (perhaps less relevant).
  • Insertion of the cannula is done manually with a lever mechanism (with Omnipod this is automatic).

At the Diatec congress there were several sessions about the first experiences with this pump.

 

Pros

The main benefits were:

  • Choice between PDM and GSM (you can choose what you want per pod).
  • Intuitive operation via Narsha app.
  • Possibility of a dark mode on the ADM (white letters on a black screen is more discreet than black letters on a white screen).

 

Negatives

The following issues were experienced as difficult:

  • Initially many error messages when inserting the needle. Thanks to an update this would now run much better.
  • The obligation to change the Pod every 3.5 days initially meant that patients sometimes had to change their pod in the middle of the night.
    • Meanwhile, there is also an option to wear the pod for 12 hours longer, although the company cannot guarantee the accuracy beyond 3.5 days.
    • In any case, at the start of a pod you have the option to set when you want to receive the alarms for pod change.
  • The loudness of the alarms is high and cannot be reduced. Hopefully this will be addressed in the next update.
  • The insulin pump can only be read with GlucoLog Web. The link to Glooko is expected in the 2nd quarter of 2023.
  • There is no integration with a CGM. So the next point is good news :-)

 

In general, the experiences with the GlucoMen Day Pump are very good...

Eoflow has already ramped up production to meet the predicted high demand for its EoPatch pump.

Hopefully this will allow them to drop the price a bit as well.

 


 

5. Partnering Diabeloop and GlucoMen Day Pump (11-1-2023)

 

Diabeloop and EOFlow Partner to Offer a Wearable AID With a Smartphone App

On 11-1-2023 it was announced that Diabeloop will integrate the EoPatch pump (= GlucoMen Day Pump) into Diabeloop.

 

This combi would be available in Europe at the end of 2023

The same announcement states that the combination of Diabeloop with the Glucomen Day Pump could be launched in Europe by the end of 2023.

(We're curious to see if this prediction can become reality.)

 

This is very good news as new starts with the AccuCheck Insight pump (which Diabeloop now works with) will no longer be possible by then.

In addition, this may become the first closed-loop system with a patch pump in some European countries, depending on the roll-out of the Omnipod 5 cfr infra.

 

PS: Are you curious about how Diabeloop works? Then take a look at the recently launched Diabeloop Academy 😉

 


 

6. Promotion Omnipod 5 started in Europe (Diatec 2023)

 

 

Omnipod 5 is the first commercially available closed-loop system with a patch pump and the start-ups in the US seem to be going well.

The first countries in Europe will be launched in mid-2023, other countries will have to wait until 2024.

The big question is, of course, which countries will be able to start first.

 

Germany will probably be the first to launch Omnipod 5 in Europe

Insulet was already prominently present at the Diatec conference at the end of January and it was explained in detail how the algorithm works.

For example, it was emphasized here that the last 4-5 pods carry more weight in the calculation of the total insulin daily dose, on which the algorithm relies.

 

Initially only with PDM

At the European launch there is a good chance that the Omnipod 5 app will not be available yet, and will therefore only be launched with the Omnipod 5 PDM.

It does have a built-in SIM card so that all data can be tracked in real time via Glooko.

 


 

7. Yuwell promotes MyGuard CT-14 in Europe (Diatec 2023)

 

The MyGuard CT-14 is a CGM from the Chinese company POCTech, a subsidiary of the Chinese Yuwell.

It is distributed in Germany by Primedic GmBH, which has since also become a subsidiary of Yuwell.

 

It has been known for some time that POCTech has a CGM with a CE label ("CT-100"), but at the Diatec congress they actually offered their CGM in Europe for the first time.

  • The sensor lasts 10 days, and must be calibrated 1x/d (1st 2 days 2x/d).
  • The transmitter lasts 2 years and contains a cell battery that you can replace yourself.
  • There is a receiver, which you can charge with a USB cable.
  • You can also receive the sensor data with the POCTech CGM app on Android and iOS mobile phones.

 

In Germany, the MyGuard CT-14 is now reimbursed by some healthcare providers.

Currently, no people are using it.

 

 


 

8. Still a reader for the Libre3 (Diatec 2023)

 

 

The Libre3 is the successor to the Libre2. The main differences are:

  • that it is 50% smaller than the Libre2
  • and that it's a real-time CGM, so the data comes to your cell phone without scanning.

 

Although it was initially said that no reader would be available, one has apparently been developed. Gray this time. 😊

Because lately we have noticed that the LibreLink app sometimes struggles to adapt in time to the updates of the Android and iOS mobile phones themselves.

 

The Libre3 is now available in the UK, Netherlands, Germany, USA, Austria and Switzerland.

Hopefully also soon in Belgium. It looks like such a handy sensor!

 


 

9. Bankruptcy Rockley Photonics (27-1-2023)

 

Rockley Photonics unveils 'clinic-on-the-wrist' sensors, offering a  potential glimpse at the Apple Watch's future | Fierce Biotech

 

Rockley Photonics is one of many companies claiming to be able to monitor glucose in a non-invasive way.

They are developing a smartwatch (Bioptx) that can measure not only glucose, but also body temperature, blood pressure, hydration, alcohol and lactate.

  • Due to their partnership with Apple, it was recently thought that the Apple Watch would soon integrate this function, which ultimately did not happen.
  • They also partnered with Medtronic in 2022, which seemed promising.

 

Despite the announcement of their bankruptcy, they would continue to work.

They hope to launch their first Bioptx product this year.

 


 

10. Can ChatGPT create a closed-loop system?

 

Recently, there was a question in a Facebook group if ChatGPT could write a closed-loop algorithm?

Below is the answer that ChatGPT gave....

 

 

 It seems that these new tools will allow the evolution in closed-loop systems to evolve even faster.

 

Last year at the EASD it was already predicted that within 5 years it will be possible to achieve a TIR of almost 100% in everyone with type 1 diabetes thanks to closed-loop systems.

A complete technological cure. 😍

 

Would it be?

 


 

In this blog post we have provided an overview of the most recent developments in diabetic technology. Whether it's new products, partnerships or updates on existing innovations, there's always something new to talk about in this fast-paced world. It is clear that progress is being made and promising solutions are available for people with diabetes. We look forward to seeing what else the future holds for this important and fast-evolving sector and will continue to keep you updated on the latest developments.

 

Many greetings,

Syncing Your CGM with Your Smartwatch

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