Tandem Diabetes Care Inc【TNDM】株式ニュース

Per TNDM 8-k dated 6-09-2019:

Tandem Diabetes Care, Inc. issued a press release announcing results from two studies of the t:slim X2™ insulin pump with Control-IQ™ advanced hybrid closed loop technology. Details from the two studies, which included data from Protocol 3 of the National Institutes of Health (NIH)-funded International Diabetes Closed Loop trial (DCLP3), and interim data from the Freelife Kid AP study, were presented on June 9, 2019 at the 79th Scientific Sessions of the American Diabetes Association.

PODD technology in combination with TNDM pump for young T1-D, said to delay development of T1-D. Very early in clinical trial.

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"Pediatric Scientific Data for the Omnipod Horizon System Presented at the American Diabetes Association’s 79th Scientific Sessions

Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the leader in tubeless insulin pump technology with its Omnipod® Insulin Management System (Omnipod System), today announced that positive results from the most recent clinical trial of the Omnipod® Horizon™ Automated Insulin Delivery System (Omnipod Horizon System) were presented during the American Diabetes Association (ADA) 79th Scientific Sessions in San Francisco, California. The study demonstrated that the investigational Omnipod Horizon System performed well and was safe for up to four days of use in children as young as two years old with type 1 diabetes.1

The study was conducted in a supervised hotel setting under free-living conditions with unrestricted meals and daily exercise and included pediatric participants between two and six years old. The study was preceded by seven days of their usual therapy at home with continuous glucose monitoring. Study participants spent significantly less time in hyperglycemia (=250 mg/dL), spent significantly more time in the target glucose range (70-180 mg/dL), and had better overnight glycemic control compared to their usual therapy, which is in line with the positive performance observed in earlier studies including older pediatric, adolescent and adult study participants. During the study, glucose control was maintained in the target range for 73% of the time overall and 85% of the time during the overnight period. The percentage of time spent in the hypoglycemic range (<70 mg/dL) was very low, at 2.9% overall and 2.0% overnight. The investigational Omnipod Horizon System includes unique features that allow diabetes management to be customized by adjusting the target blood glucose levels and insulin delivery....[more]