As expected following the 2Q17 call, Tandem announced yesterday that it has begun enrollment in the pivotal study of its t:slim X2 Predictive Low Glucose Suspend (PLGS) system with integrated Dexcom G5 CGM – see the ClinicalTrials.gov posting here. The 90-patient “PROLOG” (PLGS for Reduction Of LOw Glucose) study is a randomized crossover design comparing two three-week periods at home: the t:slim X2/G5 with PLGS algorithm vs. t:slim X2/G5 with no automation. The primary endpoint is time <70 mg/dl at three weeks – thank you FDA! – which we expect to be a slam dunk win for PLGS. Patients 6+ years will be enrolled at five excellent centers (Stanford, UCSD, William Sansum, Barbara Davis, Yale), with the great Dr. Bruce Buckingham serving as PI and the Jaeb Center for Health Research coordinating the trial. The study is expected to complete in November, meaning it needs to enroll fast. In line with the 2Q17 call, Tandem expects an FDA submission in early 2018 and a launch to follow in summer 2018. (As a reminder, the trial completion and launch timing was delayed ~1 quarter in the 2Q17 call.) Tandem still plans to make PLGS accessible to existing t:slim X2 customers via a remote software update – a nice upgrade advantage over other available pumps. Inpatient feasibility data at ADA 2017 looked strong, and we continue to see this as a low-risk product with a proven algorithm, clear FDA path, and solid upside for Tandem to get a first-gen product to market quickly – whether it will compete effectively against hybrid closed loop systems (e.g., 670G) remains to be seen. In the meantime, Tandem continues to await FDA approval of the t:slim X2 with G5 integration – the 2Q17 call did not give a specific launch timeline (previously “summer 2017,” and before that, “mid-2017”).
-- by Adam Brown and Kelly Close