Roche making Sparks

Roche have, today, announced plans to enter a merger agreement to acquire Spark Therapeutics.

Spark Therapeutics are a leader in discovering, developing and delivering gene therapies – they are the only biotech company that has successfully commercialised a gene therapy for a genetic disease in the US.

Though this is not directly linked to treatment advancements for people with type 1 diabetes, this move could one day benefit people like my son who have type 1.

For more detailed information on the merger agreement please see the below link:
Roche merger agreement to acquire Spark Therapeutics

JDRF DIY Statement

JDRF UK have recently announced their position on DIY technologies, which are on the rise among the open diabetic community

The Type 1 diabetes charity says it acknowledges the rights of the diabetes community to use such tech systems, but it does not endorse these models.

Loop Hardware
Image Credit Diabettech.com

In its DIY Diabetes Technology Statement, JDRF UK said: “JDRF UK cannot endorse the use of DIY tech systems as these products are not regulated and the use of them may carry risks. The organisation, however, respects the rights of people with type 1 diabetes to choose treatments that best fit their needs and how they manage the condition, including the use of DIY technology.”

DIY homemade artificial pancreases have been created by tech enthusiasts for the past several years with a wider adoption as the hardware/software to do this becomes more widely available. The DIY solution utilises commercial available insulin pumps and CGMs using a third party device/phone to intergrade the two.

The use of these methods has allowed people to enhance their diabetes management and it’s estimated that there are over 100 people using this type of technology.

AndroidAPS
DIY Closed Loop Software

As yet there have been no official clinical studies of these DIY systems but JDRF states “There have been peer-reviewed presentations and publications on the results of DIY systems that have shown clinical benefit.”

These systems have led to improved HbA1c levels and reduced the time spent where blood sugars are out of range.

In 2017, JDRF announced its commitment to aid open-protocol artificial pancreas systems through the awarding of grants to support certain projects.

Important: DIY systems should and have only been used by people who have a stronger understanding of diabetes and IT. It’s not recommended to make any changes to your insulin pump or CGM as this could cause risk to your own health of those you are caring for.

Medtronic Closed-Loop Breakthrough

Medtronic, yesterday, announced it has received Breakthrough Device Designation from the US FDA for its Personalised Closed Loop (PCL) insulin pump system – currently in development.

The PCL technology is designed to automate insulin delivery in a way that is real-time, personalised and adapts to the user; very much similar to AAPS. The system will also provide insights and predictive diagnostics unique to the individual, with a goal of dramatically simplifying diabetes management.

The FDA Breakthrough Devices Program helps patients receive quicker access to new technologies. Under this program, the FDA will provide Medtronic with priority review and communication regarding device development and clinical trials; thus speeding up the time to get new devices to market.

The statement does not specify which devices will use the PLC system but based Medtronic roadmap and the given descriptions it is most likely going to be the 780G and/or 890G. The development of these, alongside the FDA breakthrough, should get these devices to market significantly quicker.

Click the link for the full press release: FDA PLC Press Release

DVLA Embraces T1 Tech

With the recent mass adoption of CGM and flash glucose devices, drivers with type 1 diabetes still have to manually check their blood sugars using conventional methods.

The new guidelines have now been updated to include BS readings from CGM and flash glucose devices. However, these guidelines only cover conventional drivers and does not cover HGV or bus drivers. Hopefully, there will be a step towards covering all drivers in the not too distant future.

Nikki Joule, Policy Manager at Diabetes UK, said:
“The new guidance, which means that Flash Glucose Monitoring and Continuous Glucose Monitoring can be used in driving, is a major victory for people with diabetes.”

Further information can be found via the DVLA here

New CGM from Ascensia and POCTech

There has been a recent announcement that a new CGM from Chinese company POCTech & Ascensia will be released at some point this year with clinical trials under way.

Ascensia have entered into a global alliance with POCTech with he CT-100 is already available within selected markets. Ascensia will commercialise and have distribution rights in 13 markets where POCTech does not yet distribute, They have also agreed to co-develop next-generation products which will build on POCTech’s existing technology.

Their first CGM available in these 13 markets will be the CT-100B using their ‘Unique 4 electrodes sensor’ to improve accuracy and reliability. A second feature of this CGM is that the transmitter has a replaceable battery. However, the drawback being that this needs to be changed at every sensor change which, at the time of writing each sensor only has a 7 day usable life.

I’m sure both the sensor life and battery replacement frequency are soft limitations and will be extended by the WeAreNotWaiting community much like the Dexcom G5 and G6 products.

No official pricing has yet to be released for the CT100B but rumour is that pricing will undercut the Dexcom G6 drastically ensuring a quick adoption in the CGM market.

Known specifications at present are:

  • 30mg/dL – 450mg/dL Sensor Range.
  • 7 Day Sensor Life.
  • 2 year Transmitter Life with weekly CR16320 battery replacement.
  • 2 year Receiver life with built in rechargeable battery.
  • Pricing: TBC

User Manual
http://www.poctechcorp.com/upload/files/CT100B%20System%20User%20Manual.pdf


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