Patient-led glucose monitoring system raises questions about consumer role in mHealth, code sharing

A do-it-yourself mobile continuous glucose monitoring system developed by a diabetes patient's father who wanted daily health insight is the focus of a global virtual collaboration engaging patients and caregivers to share insight and software code to boost system functionality.

Yet, the Nightscout Project, established three years ago, faces more than a few challenges and is under federal regulatory assessment as its development community strives for approval for advanced capabilities. The challenges include issues related to safety, legal liability, regulatory oversight and system access.

A research viewpoint, published in the Journal of the American Medical Association, notes Nightscout is spurring innovation within the diabetes community and fostering novel solutions for blood glucose prediction and management, according to Joyce Lee and Emily Hirschfeld, both of the Child Health Evaluation and Research Unit at the University of Michigan, and James Wedding of the Nightscout Foundation.

"The Nightscout Project is changing current definitions of health production and patient engagement," the authors say. "Some critics may raise questions about the project such as: Should patients even be doing this type of activity? Is distributing the code dangerous? Should the code be regulated by the FDA?"

Diabetes diagnosis, treatment and management is a big focus for mHealth app and device makers. A Research2Guidance blog reveals the disease provides a healthy business proposition for developers as 70 percent of mHealth practitioners rated diabetes highest for its market potential over the next five years. Tools are fast advancing from monitoring and blood sugar reading to comprehensive functions and care management strategies beyond the clinical environment.

The JAMA viewpoint's authors note that Nightscout illustrates a valuable development for three reasons:

  1. It reflects increasing autonomy of patients and caregivers within a computing revolution
  2. It represents a new type of large-scale health production through human collaboration and social media
  3. It is the product of virtual collaboration

"As the Nightscout Project continues to develop and unfold, the questions it raises should lead to greater opportunities for patients and their families to help drive innovation in the healthcare delivery system," the authors say.

For more information:
- read the viewpoint