Some of you probably have heard or even are familiar with artificial pancreatic systems called DIY (Do it yourself). A movement of patients themselves and their families and friends (#wearenotwaiting) have developed for years systems of free access to data of MCG in the cloud from any device (Nightscout). Users of these systems promoted later the development of artificial pancreatic systems by creating free software with algorithms running on smartphones that interact with insulin pumps and the continuous glucose sensors, gather all data and program temporary insulin basal rates to achieve the stabilization of blood glucose
There are three different DIY artificial pancreas systems or projects today, OpenAps, Loop, Androidaps, and more and more patients assemble their own artificial pancreas system, having reported excellent results during last few years.
From my point of view, this drive for innovation that neither industry nor the health world promoted on their own is highly commendable, but we must not forget their limitations, problems and risks.
The approximation of each of the projects is different, Loop on its website warns on its homepage “Please understand that this project is highly experimental and not approved as a treatment, you take full responsibility for its assembly and operation and do so at your own risk” OpenAPS, instead states that “it is a safe and effective system,” makes not clear on its cover that its system is experimental, although it later states “People who build an OpenAPS are essentially doing an experiment (n-1), which they have the right to do to themselves,” and warns that it is not FDA approved. Androidaps, does not have the “experimental” word in its documentation or at least I have not found it, but insists on safety as the basis of its use and the documentation is exhaustive.
There are some problems we must consider:
- Most of the commercial pumps currently available are not compatible with these systems and therefore old models are being used, most discontinued and therefore without warranty or support from the manufacturer.
- The software used also does not have standardized support
- And of course, the use of a continuous glucose monitoring method and an insulin pump always requires a diabetes education by professionals. Diabetes is much more than a device or software.
In any case, my opinion as a professional is that we should consider several points
1.- The fact that they are not authorized neither approved by regulatory agencies makes it impossible for these systems to be prescribed by a medical professional
2.- Its use by any patient is therefore at their own risk
3.- This does not prevent professionals from providing all medical and technical support to those patients who have decided using these systems
However, the relationship that could be established with the patient is difficult, arising from the lack of official authorization of the systems, lack of knowledge by professionals of its precise functioning and the possible legal implications, that are not clear so far.
For more information, please refer to the documents of the two scientific societies that have positioned on DIY
Diabetes Australia https://static.diabetesaustralia.com.au/s/fileassets/diabetes-australia/ee67e929-5ffc-411f-b286-1ca69e181d1a.pdf
Diabetes UK: DIY closed loop for people living with type 1 diabetes