Automated Insulin Delivery System Use in Canada: Incorporating Perspectives of Both Users  and Healthcare Providers
Creators: Morrison, Amy E
Publisher: name: University of Alberta Library
Year: 2022

<p>An Automated Insulin Delivery (AID) system combines an insulin pump and glucose sensor, with utilization of a computerized predictive algorithm, to enable automated adjustment in insulin delivery rate. Do-it-Yourself (DIY) or Open-source AID systems were the first form of this technology available to people with diabetes. These unregulated systems, were developed by people with type 1 diabetes, and are broadly classified into AndroidAPS, OpenAPS and Loop, based upon the technology and algorithm which they incorporate. Individual enthusiasm for developing and using DIY systems has driven their growth and they have been the glucose management system of choice for a small but increasing number of people with diabetes worldwide. Since 2016, forms of commercially approved AID systems have been made available for some people with type 1 diabetes in Canada, and their use associated with improved glycemic and quality of life outcomes.</p>

<p>DIY AID is in contrast to most therapies, which are provided to a patient by their healthcare provider. This role reversal, an absence of the usual methods of safety and efficacy assessment, and not least the unregulated nature of DIY AID, has led to uncertainty for healthcare providers (HCP) in how best to approach DIY AID use. Therefore, we sought to review the benefits of AID and the medico-legal status surrounding DIY AID use in Canada (Chapter 1), identifying an ongoing need for clarification and clinical guidance in this setting. We next performed a scoping review to evaluate the existing evidence base and current benefits with DIY AID use (Chapter 2), this highlighted the majority of evidence available to support DIY AID to be user self-reported data, with seemingly very beneficial outcomes demonstrated. Without the requirement for licensing, or profit motivation, no randomized control trials (RCT) have been performed for DIY systems.</p>

<p>Our survey used snowball sampling to explore HCP experience and attitudes towards Commercial and DIY AID (Chapter 3). AID system use across Canada was found to be infrequent; 6-24 users of Commercial and 1-5 users DIY AID, in large clinical practices (100-500 patients with type 1 diabetes). Correlation was demonstrated between number of users in their practice and HCP system confidence. Commercial and DIY AID system education for both users and HCP, in addition to medico-legal guidance relating to DIY AID systems, were deemed to be required interventions to improve access to this beneficial technology for people with type 1 diabetes.</p>

<p>Finally, we conducted a study of Loop users (Chapter 4) with a total of 39.2 patient-years user experience, highlighting improvements in glycemic outcomes with Loop (HbA1c and time in range) using a pre-post design. These objective quantitative data were collected alongside semi-structured interviews detailing further the lived experience of Loop use in these individuals.  Participants described high levels of treatment satisfaction and low diabetes impact on their quality of life, with no safety concerns with Loop use. Prominent themes constructed from participant viewpoints were explored, these included; empowerment and control, the daily impact of living with diabetes with Loop use, quantification of risk and society’s understanding and awareness of Loop.</p>

<p>Together this work provides a comprehensive and wholistic assessment of issues relating to current AID use in Canada considering an assessment of current evidence as well as the perspectives of both Loop users and HCP caring for people with type 1 diabetes in Canada. Users of DIY systems have derived substantial benefits from AID that could benefit many more people with type 1 diabetes. Key gaps identified were in the absence of RCT, need for structured education for users and HCP and the potential value of Canadian guidelines to describe best practice, as well as the challenges of costs and access to technology. It is anticipated that expanded access and use of AID would have benefits for the health and well-being of persons with type 1 diabetes and this thesis highlights some key next steps that could facilitate this.</p>