The PROLOG (PLGS for Reduction Of LOw Glucose) study is a multi-center, randomized crossover study comparing two three-week periods of at-home insulin pump use, one period using the t:slim X2 Pump with PLGS, and another period using a standard CGM-integrated t:slim X2 Pump without automated insulin suspension.
The clinical trial will include 90 participants with type 1 diabetes ages 6 and above at five research centers across the United States and is being coordinated by the Jaeb Center for Health Research in Tampa, Fla. The primary endpoint of the study is to demonstrate a reduction in the percentage of CGM values below 70 mg/dL when using Tandem’s PLGS algorithm.
“The start of this pivotal trial is another important step forward in our automated insulin delivery programs, and comes on the heels of very encouraging feasibility study data,” said Kim Blickenstaff, president and CEO of Tandem Diabetes Care. “We remain on track to submit our t:slim X2 Pump with predictive low glucose suspend to the FDA in early 2018. Subject to FDA approval, we are preparing to launch in summer of 2018, and plan to make this new feature accessible for existing t:slim X2 customers via a remote software update using our Tandem Device Updater.”
The Tandem Device Updater is a Mac and PC-compatible application for the remote update of Tandem insulin pump software. Remote software updates have the potential to allow all t:slim X2 Pump users access to future features as they are approved by the U.S. Food and Drug Administration (FDA). Tandem is the only company that allows its customers to remotely update features on their insulin pump from home using a personal computer without waiting for their insurance to cover a new device.1 Subject to FDA approval, Tandem plans to make the new PLGS feature available to existing t:slim X2 customers via a remote software update using the Tandem Device Updater.2
“Mild to moderate hypoglycemia occurs frequently during the day for people with type 1 diabetes, but of more concern is the severe hypoglycemia which can occur at night causing seizures or even death. This is a real concern to all people living with type 1 diabetes, and especially parents of children with type 1,” said Dr. Bruce Buckingham, professor of pediatric endocrinology at The Lucille Salter Packard Children’s Hospital, Stanford University, and principal investigator of the PROLOG trial. “This new PLGS algorithm will allow for the automatic suspension of insulin delivery when glucose is predicted to be low. This is beneficial throughout the day but can be lifesaving at night when a person is otherwise unable to react.”
Tandem Diabetes Care Inc. is a medical device company with an innovative, user-centric and integrated approach to the design, development and commercialization of products for people with diabetes who use insulin. The company manufactures and sells the t:slim X2 Insulin Pump, the slimmest and smallest durable insulin pump currently on the market; the t:flex Insulin Pump, the first pump designed for people with greater insulin requirements; and the t:slim G4 Insulin Pump, the first continuous glucose monitoring-enabled pump with touchscreen simplicity. Tandem is based in San Diego, Calif.
1. Available software updates for Tandem products can be found at www.tandemdiabetes.com/updater. Additional software updates and new features are subject to future FDA approvals. Charges may apply.
2. Subject to FDA submission and approval. Charges may apply.