Nightscout New Zealand at NZSSD 2019

Introduction

This poster provides an holistic overview of Artificial Pancreas System (APS) research tailored to the NZ health context. This is achieved by considering glycaemic outcomes, psycho-social outcomes and factors that may influence adoption of APS in New Zealand. Multiple commercial and academic consortiums, and, to a certain extent, the Do-It-Yourself (DIY) APS community, have been undertaking free living studies for number of years. Hence, the review for glycaemic and psycho-social outcomes has been limited to these studies. Factors influencing adoption in NZ have been reviewed more broadly, including clinical use reports relating to commercial APS, emerging trends in APS development, regulation, and approval of APS, and cost considerations.

An APS (also known as automated insulin delivery, or closed loop) uses an algorithm to dynamically adapt insulin delivery in real time [1]. It requires a continuous glucose monitor (CGM), an insulin pump capable of sending and receiving data via bluetooth or radio frequency, and a control device that houses the algorithm. Data from the insulin pump, CGM are used to automate insulin delivery. The majority of APS under development still require user inputs such as meal boluses and carbohydrate estimates [2]. Bihormonal pumps are also being developed. These will be able to dose glucagon to more effectively prevent hypoglycaemia and give greater flexibility in lifestyle (e.g., for exercise).

Method

This poster is a targeted review. It focused on identifying the highest quality evidence for glycaemic and psycho-social outcomes from APS trials. A literature search was conducted using Medline and Google Scholar. Search terms included variants of “artificial pancreas”, “automated insulin delivery”, “closed loop”, “outcomes”, “glycaemic control”, “HbA1c”, “psycho-social”, “meta-analysis”, “systematic review”. Abstracts were reviewed by the first author. It was quickly apparent there were sufficient free-living studies to restrict the review of glycaemic and psycho-social outcomes to these studies alone. A high quality meta-analysis was identified, which was chosen to provide a broad summary of glycaemic outcomes. Specific features of two long duration (12 week) RCTs were also included. These were the only RCT trials of 12 weeks or longer identified in the literature search. One of these trials was included in the meta-analysis, the second was published after the meta-analysis.  Do-It-Yourself Artificial Pancreas System (DIY APS) studies were identified by the second author, who is a core member of the DIY APS community and a primary investigator in a number of DIY APS studies. Further literature searches were conducted on MEDLINE and Google Scholar for DIY trials, but there were no further publications identified.

Factors relevant to New Zealand was compiled by the research team discussing key factors relating to technology adoption and the New Zealand funding context. Broad searches were conducted to identify literature relating to glycaemic control in New Zealand and inequities in access to funded diabetes technologies. Further searches were conducted relating to technology adoption and use amongst people with diabetes, with key findings drawn from studies focused on CGM and CSII adoption.

Psycho-social
outcomes

Further synthesis of evidence: Psycho-social outcomes are decidedly mixed. Glycaemic benefits alone will not be sufficient to ensure uptake of APS. Usability and genuine reduction in burden of care must be achieved for maximal adoption of APS. The amount of equipment required for APS was often reported as a significant burden. Trial systems often involved multiple devices including a CGM sensor and transmitter, a CGM receiver, a locked android phone with the algorithm and an insulin pump. A key consideration for reducing device burden is to contain the algorithm within the insulin pump or as an app on the user’s phone. Relatedly the CGM receiver could also be housed in an app and/or on the insulin pump. For APS that place the algorithm and CGM receiver in the pump, thought should be given to including an app to allow the user to interface with the system via their phone.

Alarm fatigue was also a continual frustration for many participants, and is a key factor in discontinuation of CGM use [33]. Development of calibration-free CGM and providing users flexibility in terms of setting alarms may reduce alarm fatigue.

Users were divided as to how much they wished to interact with their system. There were often high levels of frustration about how much work was required to keep the system operating, with loss of connectivity between components a key issue. Many of those with high expectations prior to participating in a trial were disappointed that the system was not more automated [8]. Conversely, others wanted to be able to work with the system to maximise benefits [6]. For example, users wanted to be able to provide information about days that would be more or less active than usual, or when illness or other factors might impact their insulin sensitivity.

Glycaemic
Outcomes

The most common control treatment for RCT APS trials is sensor-augmented pump therapy [15]. There is an absence of direct evidence that compares outcomes to patients using MDI. Studies have limited recruitment of participants to existing pump users. Longer duration studies (6 month+) will be important in examining whether patients will continue to use APS consistently over time.

Factors relevant to NZ

APS has the potential to be a transformative technology for New Zealanders with T1D. Although evidence shows that all APS with published free living studies achieve improvements in glycaemic control [15], these outcomes alone will not be sufficient to ensure uptake and continued use from patients [3]. Usability, psycho-social and quality of life aspects must be considered in any funding decision: If choice of which system to fund is made on price alone, the benefits of APS are unlikely to be fully realised in New Zealand. Further, not all patients will wish to use APS. Attention should be paid to how technology can be used to maximise the effectiveness of different treatment modalities, such as using bluetooth enabled insulin pens integrated with functional apps to track insulin on board, carbohydrate consumption, etc.

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