Tandem Diabetes Care (TNDM -6.3%) slumps on almost 40% higher volume following its announcement of results from two studies of its t:slim X2 insulin pump with software called Control-IQ which automatically adjusts insulin delivery based on continuous glucose measurements (closed loop mode). The data were presented at the American Diabetes Association Scientific Sessions in San Francisco.
The company says both trials achieved the primary objective of increasing time in range (blood sugar is within the normal range) without any severe hypoglycemic events.
Results from the NIH-funded DCPL3 study showed that type 1 diabetics who used the device for six months experienced blood sugar levels in the normal range 71% of the time each day, superior to 59% for those using a sensor-augmented pump (control) (p<0.0001). Time spent above the upper limit of the normal range (180 mg/dL) was 27% in the X2/Control-IQ group versus 39% for control. Time spent below the lower limit of normal (70 mg/dL) was 1.4% for X2-Control-IQ compared to 1.9% for control. Investors appear to be have been expecting greater separation from the sensor-augmented pump.
Results from the Freelife Kid AP study in prepubertal children showed a 72% daily time-in-range rate (83% overnight). The time that blood sugar levels were above upper limit of normal dropped to 25% from 36% and time that levels were below the lower limit of normal decreased to 3% from 4%.
The times that the device operated in the active closed-loop mode in the two studies were 92% and 97%, respectively.
Shares may also be under pressure from the news about Provention Bio’s teplizumab for the interception of type 1 diabetes (T1D). Data from a mid-stage study showed a four-year delay in the onset of T1D in patients receiving a single 14-day regimen of the anti-CD3 antibody.
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