Outpatient Trials for the Artificial Pancreas: a HUGE Step Forward
The News:
The FDA approved outpatient trials of the artificial pancreas here in the U.S.
What This Means for the T1D Community:
This is HUGE!
Using a rejiggered smart phone that communicates wirelessly with an insulin pump and a continuous glucose monitor, clinicians can now plan trials of the AP on patients in real world settings.
This is a very important step in getting the artificial pancreas–a potentially revolutionary tool in the management of T1D–to market. The AP has already had success in Italy and France. Now it’s our turn to have people with T1D spending an entire day–eating, sleeping, walking around, indulging in a glass of wine if they want to!–all without having to think at all about their disease.
The best news is that all data points to these devices working well in order to “treat to range.” This means that the altered smart phone receives data from the CGM and tells the pump what to administer in order to keep the patient from going high or low.
Breakthrough T1D envisions this AP as a first generation model. Subsequent models will require faster-acting insulin–or novel ways of administering insulin to make it act more quickly. We also need better CGM’s, for which Breakthrough T1D has a number of initiatives. Third generation models would require these things as well as the involvement of other hormones–namely glucagon and amylin–to even more closely mimic the pancreas.
Slated to begin in approximately six weeks, these outpatient trials are reason for everyone–whether or not you think you’ll be racing out to get your own AP as soon as it comes to market–to be optimistic and very pleased at how far we’ve come.
