Tandem outlined thinking on Artificial Pancreas and projects at 2015 filing with FDA for their first step in their recent earrings call:
Beginning in 2013 and throughout 2014, weve actively supported leading investigators in advancing this development of artificial pancreas solutions by providing Bluetooth enabled pump, hardware and software. We are committed to continue advancing the clinical applications of Tandems technology.
To this effort, in 2014, we initiated the R&D concept phase of our artificial pancreas offering. Our first AP product will utilize Tandems proprietary technology platform and will partially automate insulin delivery based on CGM information and predictive algorithms to aid a user and maintaining their targeted blood glucose level and may reduce the frequency and severity of hyper or hypoglycemic events.
Conceptually, there are two incremental opportunities for this products algorithm. The first is an algorithm that will use a persons CGM data to predict when their blood glucose level is trending or dropping below a specific threshold. In events of reaching that threshold, the persons pump would seize insulin delivery which we refer to as predictive low suspend. Predictive low suspend is an exciting step in our artificial pancreas technology but preventing or reducing the frequency and severity of hypoglycemic events is half of the equation.
The second opportunity for this technology is not only designed to address hypo but hyperglycemia as well. And we refer to it as basal closed loop. This technology is being designed to operate similar to the predictive low suspend, accepted uses of persons CGM data to predict when the blood glucose level is trending above a certain threshold and the users pump would adjust the basal rate accordingly and accurate CJM sensor combined with our pump technology, which offers the benefit of the smallest insulin delivery increment are key to this offerings.
In the second half of 2015, we plan to file an Investigational Device Exemption or IDE with the FDA for a clinical study in rolling our first AP product. Our discussions with FDA surrounding this IDE will help decline regulatory pathway, which we anticipate will require preliminary approval and will include data from one or more clinical studies.