Automated insulin delivery system
Artificial pancreatic technology mimics the secretion of these hormones into the bloodstream in response to the body's changing blood glucose levels.
[citation needed] Currently available AID systems fall into three broad classes based on their capabilities.
[citation needed] A step forward from threshold suspend systems, predictive low glucose suspend (PLGS) systems use a mathematical model to extrapolate predicted future blood sugar levels based on recent past readings from a CGM.
A thin, biocompatible sensor wire coated with a glucose-reactive enzyme is inserted into the skin, allowing the system to read the voltage generated, and based on it, estimate blood glucose.
In general, all algorithms do the same basic functionality of taking in CGM data and based on predicted glucose level's and the user's personal settings (for basal rates, insulin sensitivity, and carbohydrate ratio, for example) then recommends insulin dosing to help bring or maintain glucose levels in target range.
Approved systems in various countries, described further below, include MiniMed 670G or 780G, Tandem's Control-IQ, Omnipod 5, CamAPS FX, and Diabeloop DBLG1.
[9] In May 2023, the FDA approved the iLet Bionic Pancreas system for people with Type 1 diabetes of six years and older.
[5][4] The device uses a closed-loop system to deliver both insulin and glucagon in response to sensed blood glucose levels.
[10] A 440-patient study of type I diabetes ran in 2020 and 2021 using a device configuration that delivered only insulin in comparison to standard of care; device use led to better circulating glucose control (measured by continuous monitoring) and a reduction in glycated hemoglobin (versus no change for the standard of care group).
[11] However, the incidence of severe hypoglycemic events was more than 1.5 times higher among device users versus standard care patients.
[11] There are several non-commercial, non-FDA approved DIY options,[12][13] using open source code,[14] including OpenAPS,[15] Loop,[16] and/or AndroidAPS.
[18] In collaboration with the Academic Medical Center in Amsterdam, Inreda Diabetic B.V. has developed a closed loop system with insulin and glucagon.
[23][24][25] The development of continuous glucose monitors has led to the progress in artificial pancreas technology using this integrated system.
The projects are funded by the National Institute of Diabetes and Digestive and Kidney Diseases, and are the final part of testing the devices before applying for approval for use.
[29] A full-year trial led by researchers from the University of Cambridge started in May 2017 and has enrolled an estimated 150 participants of ages 6 to 18 years.
[38] The aim of the partnership is to combine both technologies in a bio-artificial pancreas device, which releases insulin in response to blood glucose levels, to bring to clinical trial stages.
[33] The San Diego, California based biotech company ViaCyte has also developed a product aiming to provide a solution for type 1 diabetes which uses an encapsulation device made of a semi-permeable immune reaction-protective membrane.
The encapsulated cells were able to survive and mature after implantation, and immune system rejection was decreased due to the protective membrane.
[41] In the United States in 2006, JDRF (formerly the Juvenile Diabetes Research Foundation) launched a multi-year initiative to help accelerate the development, regulatory approval, and acceptance of continuous glucose monitoring and artificial pancreas technology.
[43][44] Grassroots efforts to create and commercialize a fully automated artificial pancreas system have also arisen directly from patient advocates and the diabetes community.
[45] In April 2024, the NHS announced it would, over the next five years, offer use of a Hybrid Closed Loop system to Type 1 diabetes patients in England.
