Canadian experts speak out on DIY artificial pancreases

“Homemade,” “DIY” or “open-source” artificial pancreases aren’t yet regulated or approved in many countries, but are still gaining in popularity—although it’s difficult to measure exactly how much, as these devices designed by and for people with type 1 diabetes (T1D) aren’t commercially available. However, it is estimated that there are between 10,000 and 30,000 users worldwide, including around 2,500 Canadians, according to data collected from online support groups.  

Current data from the BETTER registry shows that out of 3,101 people aged 14 and over and living with T1D, 1,271 people use an insulin pump (all types combined). Of these, 401 people use a commercial artificial pancreas or closed-loop insulin delivery system (e.g., Medtronic 780g, Tandem t:slim with Control-IQ) and 35, a DIY system. 

These homemade devices—which combine an insulin pump, a glucose sensor and open-source software that continuously adjusts insulin according to sugar levels—were made available by Open Artificial Pancreas (OpenAPS), a movement whose aim is to help people with T1D achieve optimal blood sugar levels with effective technologies that are easily and quickly accessible, within reach and suited to their needs. Users particularly appreciate the greater flexibility offered by DIY artificial pancreases compared with commercial systems, including the ability to customize more blood sugar control parameters such as targets, insulin sensitivity, automatic correction boluses, and to make frequent updates. For instance, there’s no need to enter carbs or a bolus into the DIY system, as the pump will handle it on its own.  

Healthcare professionals remain reluctant to discuss DIY artificial pancreases or even to support people who use them, notably due to a lack of scientific consensus not only on their effectiveness, but also their safety. However, things could change in Canada as a group of experts brought together by Diabetes Canada (doctors, researchers and patient partners) suggests that the use of DIY artificial pancreases should be regulated.  

A first Canadian consensus

Diabetes Canada’s position is in line with the international consensus issued in 2021. Canadian experts maintain that observational studies as well as user experiences provide enough evidence to conclude that DIY systems are more effective and safer than traditional treatments (e.g., non-automated pumps like Omnipod Dash or multiple daily injections [MDI]) and may even be equivalent, if not superior, to commercial devices approved by Health Canada. 

These experts believe that even in the absence of the highest level of evidence (i.e., randomized controlled trials) and Health Canada’s approval, healthcare professionals should present DIY artificial pancreases to their patients as one of the possible options available for administering insulin, in the same way as commercial artificial pancreases, insulin pumps, injection pens or syringes.

What are DIY artificial pancreases?

DIY systems are based on a control algorithm designed by and for people with T1D or their loved ones. These open source algorithms are available free of charge, and can be used with any of the continuous glucose monitoring (CGMs) systems and pumps available in Canada. Three main algorithms are used worldwide: AndroidAPS, OpenAPS and Loop. Unlike commercial systems, the algorithm is not entered into the pump, but in a cellular application that acts as a control tower for the entire DIY system.

Many Canadians living with T1D choose DIY artificial pancreases for several reasons. For instance, those who live in remote areas and don’t always have access to a T1D specialist turn to the DIY community to learn how to manage their diabetes with a DIY system. Plus, many Canadians can’t afford commercial systems. Several provinces, including Quebec and New Brunswick, and many private insurers don’t cover the cost of insulin pumps for adults. DIY systems can become a more affordable choice for some, as it combines an often out-of-warranty, less expensive pump with one of the CGMs covered by their public plan or private insurance.

Are these systems reliable?

The Canadian experts have reviewed international studies on DIY systems and analyzed the data and experiences reported by users and compared them with those of users of non-automated pumps and MDI. Results show that DIY system users spend more time in the optimal target range (i.e., between 3.9 and 10.0 mmol/L). In particular, parents of children living with T1D reported that the DIY artificial pancreas improved the family’s quality of life and sleep very significantly, as well as the daily management of blood sugar levels. 

A study conducted in Quebec followed 26 users of DIY systems and 46 users of commercial systems over a three-month period. Participants with a DIY system spent on average 17% more time in range and had fewer hyperglycemia episodes.

Concerns about DIY systems

According to analyses and surveys conducted by Diabetes Canada’s group of experts, 73% of healthcare professionals surveyed feel comfortable and able to monitor and support their patients who use a commercial artificial pancreas, compared with just 22% when asked about DIY systems.  

They cited several factors to explain their lack of confidence in DIY systems: 

• The lack of knowledge about the technology: Information—let alone training—about how algorithms work is very scarce. 
• The lack of high-quality scientific data (randomized trials).
• Medico-legal concerns: None of the algorithms used for these systems are approved in Canada (Loop was the first algorithm to receive FDA approval in January 2023 in the U.S.). When drugs or devices are approved at the federal level, their use and prescription are regulated.
• CGM and pump models used in DIY systems may be out of warranty or not designed to work together. 
• The use of computer code available online carries a risk of hacking and privacy breaches.
• The disruption of the doctor-patient relationship when the patient is the expert of their own DIY system and the resulting discomfort. 

Diabetes Canada’s recent consensus brushes away any concerns about the lack of data, as multiple observational studies on DIY systems, including over 55 million hours of real data, suggest beneficial effects on blood sugar, a reduced mental workload and an overall improved quality of life. DIY pumps have even been deemed safe and effective for pregnant women, who spend more time in range without going into severe hypoglycemia.  

T1D is a DIY condition

It’s often said that T1D is a DIY condition: people with T1D learn to manage their blood sugar on a daily basis based on their diet, exercise and lifestyle. They try different things every day to understand which strategies work best for them; they’re particularly savvy about their own condition. 

To support this autonomy, Diabetes Canada’s group of experts recommends that DIY systems should be systematically presented as an option to patients, especially as there’s a risk that a DIY system user will stop seeing their medical team if they don’t support their choice.

However, the experts highlight that patients who choose a DIY system are responsible for the technical aspect, notably coding. Healthcare professionals should be able to help their patients with setting up their DIY systems, as the options are quite similar to commercial pumps, although more customizable. 

DIY systems are constantly evolving, and we can expect the number of users to increase. People with T1D who are hesitant to make the switch due to the technical aspects (e.g., installation, understanding the algorithm and the application) now have access to online documentation and YouTube tutorials where everything is very well explained. Algorithms are also constantly improving, becoming simpler and more technically accessible to more and more people. Not to mention, the self-help community is very active on social networks. 

DIY artificial pancreases are a valid option for the treatment of T1D. Experts even anticipate that artificial pancreases, whether DIY or commercial, will become the most-preferred treatment option within a few years. However, some people will continue to prefer MDI or non-automated pumps. 

References :

Diabetes Canada Clinical Practice Guidelines Expert Working Group. (2023). Do-it-yourself Automated Insulin Delivery: a Position Statement. Canadian Journal of Diabetes, 47(5), 381-388. https://www.canadianjournalofdiabetes.com/article/S1499-2671(23)00127-2/fulltext

Lebbar, M. et al.(2023). Patient-Reported Outcomes of Adults with Type 1 Diabetes Using Do-It-Yourself Compared with Commercial Automated Insulin Delivery Systems. Diabetes, 72 (Supplement 1), 900-P. https://doi.org/10.2337/db23-900-P.

Wu, Z. et al. (2023). Do-It-Yourself Automated Insulin Delivery (AID) Systems Are Noninferior to Commercial AID Systems in Glucose Management among Adults with Type 1 Diabetes, Diabetes 72 (Supplement 1), 274-OR. https://doi.org/10.2337/db23-274-OR.

Nir J., et al. (2023). Open-source automated insulin delivery systems (OS-AIDs) in a pediatric population with type 1 diabetes in a real-life setting: the AWeSoMe study group experience. Endocrine, 81(2), 262-269. DOI: 10.1007/s12020-023-03398-4.