Diabetes Canada issues position statement on do-it-yourself automated insulin delivery

A new position statement from Diabetes Canada supports the use of do-it-yourself (DIY) automated insulin delivery (AID) systems, for patients with type 1 diabetes who choose to use such systems. Randomized trials have shown that AID systems can help in reaching glycemic targets while reducing the burden of self-management for people with type 1 diabetes and their caregivers. AID systems rely on computer-based algorithms to modulate insulin delivery by an insulin pump, based on glucose levels derived from real-time continuous glucose monitoring (rtCGM) data.1 Use of AID systems started in 2014 when patients within the type 1 diabetes community developed their own “open-source” AID systems, commonly known as do-it-yourself (DIY) AID or “looping.” Open source refers to the open publishing and sharing of the computer codes and algorithms, which are constantly being upgraded and improved by the type 1 diabetes developer community. Commercial AID systems have been available in Canada since 2016, but access varies across Canadian provinces.1 Despite the increasing popularity of DIY AID and testimonials of individuals in the type 1 diabetes community regarding their use, diabetes healthcare practitioners may have limited knowledge of these systems and may be hesitant to discuss or care for people using them given the lack of regulatory approval and poor understanding of how they work.1 Diabetes Canada recognizes that the preferences of people living with diabetes are central to shared decision making regarding their diabetes management. Patients should be able to work with their care team to find the solution that best meets their needs to deliver optimal glycemic outcomes.1 The new position statement from Diabetes Canada (and accompanying user’s guide) are designed to provide guidance for Canadian healthcare practitioners to help them support individuals using nonregulated technologies, while considering the legal and ethical issues in the use of DIY AID systems. The statement includes guidance on the use of DIY AID systems, including Loop, OpenAPS and AndroidAPS, which all have supporting evidence.1 The position statement addresses the following issues: Healthcare provider perspectives about DIY AID. Specific barriers to DIY system use that have been highlighted by healthcare providers include lack of exposure to these systems, lack of high-quality published data, lack of regulatory approval, medico-legal concerns and feeling threatened by “role reversal” where the patient is the expert in DIY AID. Individual perspectives about DIY AID. People choosing DIY AID do so for several reasons: transparency (they want to see how the system works), interoperability (they want options with regards to the device, algorithm and continuous glucose monitoring [CGM]), desire for open-source software, limited availability or accessibility of commercial options, desire for customization (including the ability to set lower blood glucose targets compared to commercial systems), access to user-led design features, the ability of DIY systems to make changes faster than their commercial counterparts, helping patients feel empowered by the ability to customize their systems, and improved quality of life, sleep quality and glycemic management. Efficacy of DIY AID. Multiple retrospective and prospective studies of DIY AID, incorporating more than 55 million hours of real-world data, consistently suggest beneficial outcomes for both glycemia (increased time in range [TIR], reduced A1C without increasing hypoglycemia) and quality of life. This has been confirmed in a recently published randomized controlled trial. Evidence also suggests that a wide range of people with type 1 diabetes can benefit from AID regardless of their education or comfort with technology. No comparative studies have evaluated commercial versus DIY AID systems; therefore, no assumptions can be made about the superiority of one over the other. Given the growing evidence base, Diabetes Canada believes it is no longer appropriate to cite a lack of evidence as justification for not discussing or supporting DIY AID use. Other issues. The position statement examines DIY AID safety, accessibility and costs, use in special populations (pregnancy, children) and ethical and medicolegal considerations.1 DIY AID user’s guide for healthcare providers Diabetes Canada has published a companion DIY AID user’s guide. It is intended to provide clinicians with guidance on how to be inclusive of DIY AID, from discussing therapeutic options to supporting patients during follow-up care, helping patients improve their glycemic metrics and quality of life, and to lessen burden. Specific topics covered in the user’s guide are summarized below: Discussing DIY AID as a therapeutic option Preparing individuals for a successful transition to DIY AID Navigating DIY AID to optimize settings Clinical considerations for optimizing DIY AID settings Exercise adjustment factors to consider with DIY AID systems DIY AID online resources Key self-management education points for DIY AID users Frequently asked questions.2 Diabetes Canada concludes that in the spirit of shared decision-making and facilitating self-management, and in keeping with the ethical and legal principles of duty of care and autonomy, healthcare providers are obligated to discuss all available options with patients, including making them aware of DIY AID along with commercially approved options. Healthcare providers do not need to become experts in the setup and building of a DIY system, but should be able to direct patients to the online diabetes community to learn more about DIY systems. Healthcare providers should support patients at follow-up appointments to adjust and optimize settings. In addition, reviewing glucose and insulin data should still be a part of all routine follow-up.1 References 1. Halperin IJ, Chambers A, Covello L, et al; Diabetes Canada Clinical Practice Guidelines Expert Working Group. Do-it-yourself automated insulin delivery: a position statement. Can J Diabetes 2023;47:381e388. (accessed August 15, 2023). 2. Chambers C, Mackay D, Farnsworth K, et al; Diabetes Canada Clinical Practice Guidelines Expert Working Group. Do-it-yourself automated insulin delivery: a health-care practitioner user’s guide. Can J Diabetes 2023;47:389e397. (accessed August 15, 2023).

Diabetes Canada issues position statement on do-it-yourself automated insulin delivery

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