A New International Consensus Statement on Artificial Pancreases

Anyone with type 1 diabetes (T1D) will tell you that a cure or a technological breakthrough has been highly anticipated for years! Although no miracles are expected in the short term, ongoing technological advances for diabetes management still help to alleviate the burden of living of T1D. And while there is still room for improvement (e.g., in terms of insurance coverage), these expensive new tools have become increasingly accessible over the past few years. 

For instance, new versions of continuous glucose monitoring (CGM) systems (e.g., FreeStyle Libre, Dexcom, Guardian) and new types of insulin pumps such as hybrid closed loop systems, also known as artificial pancreases, are constantly being developed to improve accuracy, ease of use and quality of life. 

To sustain these improvements over time, it might be necessary to take a step back, assess the whole situation and identify what is needed. This is precisely what the European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA) set out to do when they drafted the most recent consensus statement identifying the pros, cons and recommendations regarding artificial pancreases.

What is an artificial pancreas?

Artificial pancreases, or hybrid closed loop systems, refer to insulin pumps that use continuous glucose monitoring (CGM) readings (e.g., Guardian 3, Dexcom) to automatically adjust some of the insulin delivered. 

This is done using an algorithm (computer program) that adjusts insulin delivery throughout the day based on blood sugar levels in order to minimize hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar). 

There are “commercial” systems (e.g., Medtronic 670/770/780G, Tandem Control-IQ), which have received regulatory approval (e.g., Health Canada), and unregulated, “non-commercial” systems that were developed by communities of people with T1D. 

Benefits, limitations and prerequisites 

Numerous studies report the benefits of using these systems for blood sugar management (less hypo- and hyperglycemia and better glycemic average), but also for quality of life, including improved sleep, reduced anxiety and relief of some of the burden associated with daily diabetes management.

However, while the benefits of these technologies have been shown, the consensus also points to some challenges for users and their healthcare team. 

Since the system is not yet entirely automated, users must still perform actions such as entering carb counts into the pump at mealtime or figuring how to manage blood sugar levels during physical activity. Users also need to be knowledgeable enough to detect and resolve certain system problems (e.g., infusion problems, pump or software failure). 

There are also limitations related to the technology itself (e.g., communication issues between devices) or its use (e.g., skin reactions due to sensor or catheter adhesives, occlusion of infusion devices). 

The consensus also highlights one of the main limitations of these technologies: accessibility. Many people with T1D don’t have access to these expensive technologies due to lack of insurance coverage. 

Taking into account the limitations mentioned above, the consensus identified some prerequisites for anyone who wants to make the most of what current artificial pancreases can offer:

• Have the basic skills and knowledge to use the pump (e.g., be comfortable with the technology and overall operation of the pump, know how to use the CGM and how to count carbs, and have other basic diabetes management knowledge);
• Have realistic expectations (e.g., know the limitations of the device and not expect miracles);
• Have the necessary technical, financial and social support (e.g., follow-ups by a healthcare team familiar with these devices, insurance coverage).

A comprehensive approach 

The consensus is not just for people living with diabetes; it also makes recommendations for regulatory bodies (e.g., Health Canada), healthcare professionals and accessibility policies, etc.

Here are some examples:

• Regulatory bodies. The consensus emphasizes, among other things, the need to clearly define the steps and conditions necessary for a new technology to get approved, and the importance of identifying methods to evaluate “non-commercial” (or DIY) systems. Several studies suggest that these systems are quite effective, but there is no available data on the frequency of problems (e.g., technical issues).
• Healthcare professionals. The consensus supports the importance for healthcare professionals to be aware of, and stay up to date on, available technologies in order to inform their patients of available options, including their strengths and weaknesses, and to provide the necessary support for the use of the technologies.
• Accessibility policies. In the face of accessibility issues, the consensus supports the importance of addressing and attempting to reduce health inequities. In some provinces in Canada, adults without any private insurance might have to fork out approximately $7,000 for the purchase of an insulin pump, not including the cost of supplies. In Quebec, the INESSS (link in French only), an organization that evaluates new healthcare treatments or technologies, recently recognized that broader coverage may be warranted.

The consensus can be found here.

By painting a picture of the current situation and making recommendations, the consensus aims to encourage the continuous improvement of artificial pancreases, to promote their safe and effective use, and to improve accessibility for those who wish to benefit from them.

The BETTER registry shows that more and more people with T1D are adopting artificial pancreas systems. They are generally highly appreciated, even though they are not flawless. At the Diabetes Canada conference in November 2022, we presented the first results of a study showing that all available “commercial” and “non-commercial” (DIY) systems, for the most part, allow users to achieve good blood sugar control.

Référence :

• Sherr, Jennifer L et al. “Automated insulin delivery: benefits, challenges, and recommendations. A Consensus Report of the Joint Diabetes Technology Working Group of the European Association for the Study of Diabetes and the American Diabetes Association.” Diabetologia, 1–20. 6 Oct. 2022, doi:10.1007/s00125-022-05744-z