Katarina Braune, Rayhan A. Lal, Lenka Petruželková, Gary Scheiner, Per Winterdijk, Signe Schmidt, Linda Raimond, Korey K Hood, Michael C Riddell, Timothy Skinner, Klemens Raile, Sufyan Hussain on behalf of the OPEN International Healthcare Professional Network and OPEN Legal Advisory Group.

Open-source automated insulin delivery: international consensus statement and practical guidance for health-care professionals. Lancet Diabetes Endocrinol . 2022 Jan;10(1):58-74.

Earlier we reported on new closed-loop insulin systems and mentioned the the ‘#WeAreNotWaiting movement’: an online community of people with diabetes who are connecting (‘looping’) their pumps and CGM devices themselves. Around the world an increasing number of people with diabetes, numbering in the thousands, are using these open-source automated insulin delivery (AID) systems and are reporting very good results in terms of glycemic control and safety. However, since these systems are set up and maintained by (caregivers of) users themselves, often using out-of-warranty components (i.e. pumps and sensors), safety, ethical and legal issues may arise:

 

• Producers of commercial AID systems offer call-in helplines, for fast troubleshooting in case of problems with system components, whereas for users of open-source AID systems the online search for suitable resources can be difficult
• Healthcare professionals (HCPs) have a duty to respect their clients’ autonomy while enabling them to make informed choices, but many HCPs currently lack the knowledge of open-source AID systems
• In contrast to commercially available AID systems, open-source AID systems are not approved by regulatory bodies. HCPs may be worried about providing care to people with diabetes who are using unregulated systems, e.g. for fear of prosecution

 

 

A consensus statement was recently published by the OPEN International Healthcare Professional Network and OPEN Legal Advisory Group (including Per Winterdijk, pediatrician at Diabeter and himself using an open-source AID). The goals of this consensus statement are:

 

• To review:
  • Current evidence
  • Description of technologies
  • Discuss ethical and legal issues
• Providing an international health-care consensus, with clinical guidance, for implementing open-source AID systems in real-world clinical settings

Key points:

• Real-world data from users, devices and HCPs support the notion that open-source AID systems provide safe and effective treatment options for people with diabetes
• Open-source AID systems can be used alongside commercial AID systems, by a wide range of people with diabetes
• Respecting people’s autonomy implies that HCPs should respect people’s choice for open-source AID systems and support them in their use of these systems
• HCPs should try to know about all treatment options, including open-source AID systems, being able to provide (caregivers of) people with diabetes an overview of all AID systems while clearly explaining potential risks and benefits
• HCPs who do not have sufficient knowledge of open-source AID systems, or are worried about legal/regulatory issues, should work together with other HCPs/centers who can support them in this respect
• For all AID systems, also commercial systems:
  • It should be disclosed how they operate so that (caregivers of) users and HCPs are able to make informed decisions
  • (Caregivers of) Users should have real-time and open access to personal data, at all times

• Benefits of open-source AID systems (despite lack of regulatory evaluations and commercial technical support) include:
  • Wide availability and access
  • Device and platform interoperability
  • Customisablity
• Keys to successful use of open-source AID systems:
  • Claryfying users’ goals
  • Setting realistic expectations
  • Guidance to optimal use of system before aiming towards tight glycemic control
• HCPs should:
  • Not universally recommend open-source AID systems over available commercial systems
  • Not violate local law or organisational governance: if ethical and effective treatment is considered to be unlawful/uncertain, HCPs should work with health-care authorities to clarify local/regional policies
• Since randomised controlled trials with open-source AID systems are difficult to organise (due to the already mentioned legal/regulatory issues), real-world evidence should be considered for regulatory processes

 

As the authors state:

Please click here for the full-text pdf.