Greetings MDDT Administrators,
Our community, known as
#wearenotwaiting movement have
a number of projects which help assess and measure outcomes for patients
engaged in home therapy of type 1 diabetes.
We noticed the new MDDT pilot program and believe our tools can be jointly developed with the FDA to increase public safety, as well as set an example for other vendors in getting to market faster.
Before I describe the device and some of the future plans, I'd like to briefly
mention that the #wearenotwaiting community has many open source projects,
ranging from alarm generation,
real-time-pump history,
near-real-time command and control
(bolus, temp basal, suspend), and
dosing recommendations.
As open source efforts, we expect to see these disparate, patient-led efforts
converge, and seek a forum for doing so safely, with as much FDA oversight as
makes sense. We propose the following project, called Nightscout, as an
initial device for the pilot program, to establish a forum for working with
other diverse projects. These patient led efforts outline the beginning of an
open source artifical pancreas system, which we believe should be developed in
public view, and with FDA oversight.
Our initial proposal is a project called Nightscout. The MDDT pilot program
looks like an excellent opportunity for the community to develop the project
co-operatively with the FDA. The Nightscout project has an FDA pre-market
submission request for meeting currently being developed
(pdf,
html)
at the agency's encouragement; the following descriptions are borrowed from the
pre-sub.
Sincerely,
Ben West
[edited contact details]
Device description and future plans follow: