Memorandum

Full results from Tandem’s Control-IQ pediatric pivotal trial (n=101) published in NEJM – August 27, 2020

Second publication in the prestigious journal for Tandem/Control-IQ, following publication of adult pivotal results in October

This morning, full results from Tandem/Dexcom’s Control-IQ pediatric pivotal study were published in NEJM – the second publication for Control-IQ in the prestigious journal, following publication of adult pivotal results in October. The paper, “A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes” is authored by a who’s who list of KOLs, led by Dr. Marc Breton (University of Virginia), on behalf of the iDCL Trial Research Group. Results from the study were first read out at ATTD 2020 by the always impressive Dr. Paul Wadwa (Barbara Davis Center). Today’s publication comes on the heels of Tandem’s announcement in June of expanded pediatric indication for its t:slim X2 pump with Control-IQ. Control-IQ first launched in January.

  • There were no surprises following the ATTD readout from the full results of this stellar study, which randomized 101 children ages 6-13 with type 1 diabetes to the Control-IQ closed-loop group (n=78) or the control group (n=23) where patients used “either a sensor augmented pump without automated insulin dosing or Tandem’s t:slim X2 pump with Basal-IQ predictive low glucose suspend.”

  • The study ran for 16 weeks and children in the Control-IQ group saw a huge Time in Range improvement from 53% at baseline to 67% (p<0.001) at the end of the study – equivalent to 3.4 (!) more hours in range per day or 24 more hours a week (think of the productivity gains!) or 100 more hours a month. The control group saw a smaller time in range increase from 51% at baseline to 55% at the end of the study. Overall mean glucose levels were also significantly lower in the Control-IQ group at 162 mg/dl compared to 179mg/dl for the control group (p<0.001).

  • Although the difference in the “control group” might sound small, we venture anyone with diabetes would take that in a heartbeat – it’s an hour more a day, or 30 more hours a month, and that’s, gulp, with Tandem’s second best pump! We love the whole direction that AID is taking everyone on even hybrid TIR – it’s better, just better.

  • Notably, as with the adult pivotal, Time in Range increased most significantly overnight with children using Control-IQ reaching 80% overnight Time in Range compared to 54% in the control group. Time spent in hyperglycemia, defined as >180 mg/dl was significantly lower in children using Control-IQ at 31%, compared to 43% for the control group (p<0.001) without any increase in time <70 mg/dl. Time in severe hyperglycemia also increased substantially. Finally, the Control-IQ system saw participants with a median time in active closed-loop of 93%.

 

--by Hanna Gutow, Albert Cai, and Kelly Close