As artificial pancreas devices in development continue to move closer to hitting the market, talk of how the devices will be regulated is starting to gain momentum. This July, the National Institutes of Health (NIH) will be organizing a workshop to discuss the technology and how the devices can be made safe and effective for diabetic patients.
“The purpose of this workshop is to have a multidisciplinary discussion of current and emerging systems and their components, including integration strategies, clinical testing modalities, psychosocial and usability factors, regulatory and reimbursement considerations, and prospective areas of research to accelerate the availability of a wearable, affordable, and user-friendly artificial pancreas (AP) for individuals with diabetes,” said the NIH’s website. The discussion will be hosted by the NIH National Institute of Diabetes and Digestive and Kidney Diseases.
The committee has released a number of topics that will discussed in the workshop, including how the automated glucose control systems can be tested and personalized for each individual patient. In addition, the committee is interested in discussing barriers that could influence patient behavior, as well as what cybersecurity measures should be put in place to ensure patient safety.
While waiting for devices to be approved, patients have begun to build their own closed-loop systems using modified insulin pumps and open-source software. The software – known as Open Artificial Pancreas System, or OpenAPS – was originally developed by a patient with type 1 diabetes and her husband.
The patient-built system is made up of a Raspberry Pi mini-computer, a Medtronic insulin pump with a Carelink USB, and a Dexcom continuous glucose monitoring (CGM) system. The software code was released as an open-source program in 2015, and over 40 people are reportedly using it to run their devices.
Multiple medical device companies – including Cellnovo Group and Medtronic – are furiously working toward getting their artificial pancreas systems on the US market. Cellnovo and TypeZero Technologies recently participated in an NIH-supported artificial pancreas clinical trial in patients with type 1 diabetes.
Meanwhile, Medtronic is reportedly close to having final data from a trial of its Hybrid Closed Loop System. According to the company, they plan to apply for FDA approval in June, with eyes on an April 2017 launch date.