Now that we have commercial Artificial Pancreas Systems, is there still a place for DIY APS?

Published: Posted on

Dr Rachael Dickson explores whether advances in market authorised artificial pancreas systems spell the end of DIY APS and resolve the legal uncertainty that these systems raise.

Over the last decade the #WeAreNotWaiting community has come together to develop DIY Artificial Pancreas Systems to help them manage their diabetes. Frustrated by the lack of commercial options to connect insulin pumps to continuous glucose monitors users took the development of software to help them communicate into their own hands. Until recently, DIY artificial pancreas systems were the only closed loop systems available. In recent years, however, commercial manufacturers have started manufacturing artificial pancreas systems too.

The interest in bringing closed-loop systems to market by device manufacturers is certainly a positive response for the #WeAreNotWaiting community. Unlike their DIY counterparts, commercially available artificial pancreas systems have been subject to the rigorous testing required to be issued a CE mark. As a consequence, there is less legal uncertainty surrounding their use than there is for DIY APS. One might think that this could spell the end of DIY APS as users move on to commercial APS.

Download presentation here

In a webinar hosted by the Danish Diabetes Association on the 16th of December 2020 Dr Rachael Dickson explored the question of whether the advances in market authorised artificial pancreas systems spell the end of DIY APS and resolve the legal uncertainty that DIY systems raise for users, clinicians, other health care professionals, family members of users, developers, and others in the diabetes ecosystem. In her presentation Dr Dickson gave four reasons why the availability of these devices on the market would not necessarily lead to the end of DIY APS nor neatly tie up all of the legal uncertainties.

The Future of DIY?

The first reason why the availably of commercial systems will not necessarily spell the end of DIY APS is that not everyone who wishes to access commercial systems will be able to. In order to access a commercially available closed-loop system on the NHS the patient needs to navigate a bureaucratic system that is dependent on whether the NHS has listed a device as available, whether the local NHS Clinical Commissioning Group has approved those devices for use in their area, and whether the individual patient then qualifies to get one. Moreover, as commercial systems are expensive not all patients who wish to purchase them privately will be able to afford them.

The second reason DIY APS may not disappear is that the innovations take longer to get to market in commercial systems than in DIY ones. As DIY APS developers do not submit their software for testing and approval by regulators, innovations can be adopted quickly. In the time it takes for commercial manufacturers to move from development to market authorisation, DIY systems may have incorporated new features. For some users this will make DIY APS preferable to commercial systems.

The third reason why people may not move away from DIY APS is that patients who use these systems have become experts on how they work. The current reluctance and inability for clinicians to engage with DIY APS in clinics due to a lack of official guidance on how to do this may place some clinicians at a disadvantage in terms of managing the commercially available systems. Some clinicians are engaged, but others are not. Thus more work is needed to ensure clinicians are able to adequately support DIY users in both using their DIY system but also in transitioning to a commercially available closed-loop system.

The fourth reason why DIY may not disappear is that the DIY community is a massive asset. The community provides support in using the device from the perspective of people who use the devices too, this is invaluable and markedly different to the advice in clinics as it is informed by experience. The support provided is not just technical, the community also provides advice on lifestyle factors and support for emotional wellbeing. This community aspect to DIY could produce a loyalty to the systems even after authorised devices come to market.

The Future of the Law?

Thinking that the availability of commercial closed-loop systems will solve the legal questions associated with DIY APS is a bit like papering over a crack because it does not substantively deal with the central issues. The regulatory framework governing medical devices remains unwieldy, making it difficult for different actors in the ecosystem to ascertain responsibilities and obligations, as well as the rights afforded to patients. 

In addition, gaps in regulatory framework on how algorithms and machine-learning are to be regulated are not sufficiently forward-looking so these need to be tackled. Clearer pathways for reporting and acting on harms are needed to provide assurances to both users and clinicians supporting users. 

Further, DIY APS is an example of a wider trend of patients taking their medical treatment into their own hands. Thus, the power dynamics and policies of medical practice need work to better reflect and accommodate this expertise. Guidance and policies need to be developed to facilitate this new reality in clinical settings. If this is to be successful, such policies must be co-produced and informed by those they will effect. 

Viewing DIY APS as citizen science, and extending its community-based methods into areas of law, regulation, policy, and practice would be one way to broach these challenges. In the meantime, it seems DIY APS will be a feature of diabetes management for the foreseeable future. 

Written by: Rachael Dickson and Joseph Roberts

Funding: Work on this was generously supported by a Wellcome Trust Investigator Award in Humanities and Social Sciences 2019-2024 (Grant No: 212507/Z/18/Z) and an ESRC Impact Acceleration Award.