By Lisa Foster-McNulty, MSN, RN, CDE
Bigfoot Biomedical is making progress towards getting its artificial pancreas on the market.
The company announced in August that it obtained approval from the FDA to enroll up to 50 participants in a trial of its system in development. This will be a clinically supervised test on an algorithm that translates glucose values from a Dexcom CGM into insulin delivery instructions for an insulin pump. Back on June 29, the FDA gave Bigfoot an investigational device exemption (IDE) which relaxes certain requirements that the FDA has for premarket clinical trials, so that the company’s pump controlling software can be evaluated. Bigfoot will do a feasibility study which must be limited to 50 participants and five clinical facilities.
Artificial pancreas developers have to navigate this extra round of trials because the FDA considers an artificial pancreas (AP) system to be new and also high risk. This study will be the first of three steps needed to submit an application for premarket clearance approval for the system. Bigfoot is given one year to complete this step and report the findings back to regulators. The next step would be a hotel study where participants use the device under less stringent supervision. It is projected that by early 2017 there would be a study lasting three months that looks more like a traditional clinical trial for a new model of an existing medical device. Bigfoot would be submitting its premarket clearance application to the FDA before year-end of 2017 if all goes as planned.
Bigfoot is the brainchild of computer scientist and mathematician Bryan Mazlish, who is the dad of a child with diabetes. Sleep deprived since 2011 from checking his son’s nighttime glucose, he set out to use a smartphone and the Cloud to get remote access to CGM readings. He worked on cracking device code to figure out if he could make it work, then to see if he could use a remote to operate a pump. Working outside the FDA’s radar, he recruited former JDRF CEO Jeffrey Brewer, another diabetes dad, who brought tech startup and regulatory experience to the project. They also enlisted diabetes dad and Nightscout developer Lane Desborough to join them from Medtronic as chief engineer. By the middle of 2015, Bigfoot had a development agreement with Dexcom. Today Bigfoot has grown to about 40 members.
Bigfoot’s Chief Financial Officer since 2015, Jon Brilliant was previously senior advisor to the Merck Global Health Innovation Fund. Through raising private capital, he helped to acquire Asante’s pump technology when they ceased operations in May of 2015. The interface of the Snap pump, but not the pump body itself, was changed by Bigfoot’s designers. Bigfoot’s community relations director Melissa Lee explained that Bigfoot doesn’t consider itself to be a device company , but rather a software company with a device, and a service company. They are in the business of automated insulin delivery, and want to provide complete diabetes solutions. Bigfoot doesn’t want to merely deliver a commodity.
Researchers are recruiting juveniles (age 7 and up) and adults who have been diagnosed with Type 1 diabetes for a minimum of one year, and have an A1c of 10% or lower. The study has two primary outcomes. The first is to evaluate and graph the performance of Bigfoot’s algorithm to dictate insulin delivery in response to CGM signals over a 48 hour time frame. The second is to assess the safety outcomes of using the pump system. The secondary outcome of the study is to measure real-time blood glucose control with the pump’s use. The trials will be conducted at the Sansum Diabetes Research Institute in Santa Barbara, Stanford University School of Medicine in Stanford, and the Barbara Davis Center at the University of Colorado.
To see if you might qualify to participate in the trial, go to https://clinicaltrials.gov/ct2/show/NCT02849288?term=Bigfoot&rank=1