Regulatory approval edges nearer for DIY diabetes technology

Jack Woodfield
Thu, 11 Oct 2018
Regulatory approval edges nearer for DIY diabetes technology
People with diabetes could be one step closer to having 'do it yourself' technology approved by regulators, it has been announced.

Tidepool, a not-for-profit organisation, is working with the US Food and Drug Administration (FDA) in a bid to find a way to get their Loop app, available for the iPhone, officially approved for the public.

Loop is based around an algorithm that runs every five minutes to try and correct high or low blood sugar levels. It is thought there are around 1,500 people using it.

At the moment a community of people with type 1 diabetes are adapting their technology so their continuous glucose monitor communicates with their insulin pump. The movement even has its own hashtag, #WeAreNotWaiting.

Engineering technology means people can make artificial pancreas-esque systems that allow insulin to be delivered automatically and people to take fewer blood glucose readings.

However, creating these systems requires significant engineering and diabetes expertise, and doing so independently is not recommended.

Systems such as OpenAPS, Loop and AndroidAPS are unregulated which means many people are cautious about using them. Without official approval they are not currently advised for those with diabetes to use.

Last year - in collaboration with Tidepool - the type 1 diabetes charity JDRF launched a campaign entitled its Open Protocol Initiative. The aim of the programme was to help open more doors for personalising technology and getting different devices to talk to each other so they can work together.

JDRF is also looking to support a second type of technology which works in a similar way. The organisation is trying to find a development pathway for the artificial pancreas.

Speaking last year, JDRF's Chief Mission Officer Aaron Kowalski, said: "To support innovation and enable type 1 diabetes families to use an open-protocol approach safely, we need to ensure the regulatory pathway is clear, and we will work with industry stakeholders to make devices compatible.

"By making this approach more accessible to a wider group of people with diabetes, users of insulin delivery devices will be able to manage their blood glucose levels better, and in a way that works best for them."
Leave a Comment
Login via Facebook
or
Have your say in the Diabetes Forum
Your comments may be moderated. Please report any spam, illegal, offensive or libellous posts.