Overview of Product Development¶
The sponsors would like to discuss appropriate regulatory controls that protect open source authors’ free speech as well as provides FDA with an appropriate framework to fulfill their mission. The sponsors passionately share the FDA’s mission to protect and promote public safety, a key reason Nightscout development is done as a “public performance,” and freely shared.
Given the community’s frustration with safety in available medical devices to manage type 1 diabetes therapy, we believe there are opportunities for open source authors and FDA to work together. One such opportunity is in post-market surveillance. We have developed an aggregation tool which redisplays, depersonalized, many Nightscout remote monitors in a single “spaghetti plot.” We propose modifying the aggregating tool to automatically compile and submit reports to the FDA in order to aide in post market surveillance of devices used in diabetes therapy, and to generate useful research data on larger populations.
In the interest of safety, we need a single display to contextually manage type 1 diabetes. We will add data transfer from Medtronic insulin pumps to obtain “treatment” data consisting of the bolus wizard and bolus records. Additionally, the display will automatically show both the treatment data, carbohydrates consumed, insulin, and carbohydrate ratio, from insulin pumps overlaid with glucose readings from the Dexcom CGM.
In addition, we will also explore integrating with many other health, fitness, and nutrition APIs.
We anticipate adding indicators showing the connectivity status of the uploader device, as well as battery status, and other operational details of the system. These details will help quickly assess validity of the data, and whether or not the system is working and trustworthy.
During development, the community has expressed an interest in developing access controls to help protect who can access displays. We anticipate development of “named views” which can be used to control who accesses the remote monitor website, as well as when and how. These views may optionally be protected by user name and password type of login system, or through creating unique and opaquely encoded tokens explicitly for sharing. We have found that the flexibility in sharing information in public outweighs the relative risks in the data being made public. As the community and software matures, we anticipate personalizing the access controls to meet the needs of its users.
One criticism of open source is the lack of commercial support for individuals who lack the ability to safely assemble and operate their own rig. While the open source culture provides a large community able to train and offer support, the project remains accessible only to those with sufficient technical ability to assemble and debug their own equipment. We propose that the community would be safer if the public could buy assembled rigs on the market with support contracts to help ensure high quality operation for individuals lacking the time and effort. However, we are concerned that the current regulations considering this a “high risk” device prevents unprepared individuals from obtaining the help they need.