This multi-center randomized control trial (RCT) will compare efficacy and safety endpoints
using the insulin-only configuration of the iLet Bionic Pancreas (BP) System versus Usual
Care (UC) during a 13-week study period. Participants may be enrolled initially into a
screening protocol and then transfer into the RCT protocol, or they may enter directly into
the RCT protocol. The RCT will be followed by an Extension Phase in which the RCT Usual Care
(UC) Group will use the insulin-only configuration of the iLet Bionic Pancreas (BP) System
for 3 months. At the completion of use of the BP system in the RCT only, participants will
enter a 2-4 day Transition Phase and be randomly assigned to either transition back to their
usual mode of therapy (MDI or pump therapy) based on therapeutic guidance from the iLet BP
System or transition back to their usual mode of therapy based on what their own insulin
regimens were prior to enrolling in the RCT.
There is an optional ancillary study to assess the safety of utilizing self-monitored blood
glucose (SMBG) measurements instead of continuous glucose monitor (CGM) measurements as input
into the iLet for ~48-60 hours. The Study is intended to mirror a real-world situation where
CGM may not be available for an extended period of time (eg, user runs out of sensors and is
awaiting new shipment).
Stanford is currently not accepting patients for this trial.
For more information, please contact Liana Hsu, BS, 650-725-3939.
Stanford Investigators
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