Real-World Use of Open Source Artificial Pancreas Systems – Poster Presented at American Diabetes Association Scientific Sessions
The OpenAPS community submitted an abstract that was accepted for a poster presentation at the American Diabetes Association’s Scientific Sessions meeting. The embargo lifted this morning, so you can read the abstract here or read below for the content from the poster to get insight from outcomes observed by those individuals who self-built hybrid closed loop artificial pancreases and insights we hope the healthcare provider community and diabetes community can learn from.
Over a period of 16 months, over 81 patients (as of June 8, 2016) worldwide have built Artificial Pancreas Systems (APS) with off-label use of existing insulin pumps, continuous glucose monitors (CGM), and open source software (known as OpenAPS).
The patients have been using these systems outside of any clinical trial setting for more than 150,000 total hours.
OpenAPS is designed to be, and has been, far safer than standard pump/CGM therapy, as measured by duration of hypoglycemia and hyperglycemia, with no reports of severe hypo or hyperglycemic events. It has allowed patients and caregivers remarkable improvements in quality of life due to increased time in range, uninterrupted sleep, and peace of mind.
COMPONENTS OF AN OPENAPS SYSTEM:
- Continuous glucose monitor
- Older model insulin pump that allows user to remotely set temporary basal rates
- A “controller” device (small computer like Raspberry Pi or Intel Edison)
- Battery or power source for the controller
- A “translator” device to read/write to the pump (Carelink USB stick or TI radio stick, etc.)
At the time of the abstract submission, 18 users (out of 40 users total using the system at the time) shared and self-reported their data and experiences from using the system.
OpenAPS users (18 respondents, 67% male / 33% female, 61% adults / 39% children, median 27 years old (SD 14.5 years), 15 years with diabetes (SD 11.7 years), 10 years on pump therapy (SD 3.6 years), 3 years on CGM (SD 2.5 years)) were surveyed on quantitative and qualitative measures of their experience using their self-built APS. While using OpenAPS, self-reported outcome measures showed median HbA1c dropped from 7.1% (SD 0.8%) to 6.2% (SD 0.5%), and median percent time in range (80-180 mg/dL) increased from 58% (SD 14%) to 81% (SD 8%). All but one respondent reported some improvement in sleep quality, and 56% reported a large improvement.
Users caution that DIY APS implementations require significant effort to build and maintain, and pointed out that these systems cannot be considered a “technological cure,” but were extremely satisfied with the “life changing” improvements associated with using an APS.
- Many users reported their health care providers (HCP) as being supportive, but some expressed disappointment at lack of interest from their HCP.
- These experiences are instructive for what patients can expect from commercial APS when they become widely available, and can help HCPs be prepared to set patients’ expectations properly when discussing or recommending an APS.
QUESTIONS FOR HCPs:
- Artificial pancreas systems are already here. One of your patients may already be building one. Would you know it if they are? Do you discuss with your patients which tools they choose to use to help manage their diabetes?
- APS are a powerful tool, but not a cure. Patients and HCPs will each still need to do a lot of work to use them effectively to improve diabetes management.
- Patients and HCPs must educate themselves and each other on how APS can be used effectively in daily life.
You can find out more about OpenAPS on OpenAPS.org, from the reference design to frequently asked questions (such as what hardware is needed and where the code and documentation can be found) and links to news articles on OpenAPS community.