A clinical trial primarily funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has found an artificial pancreas system could effectively control blood glucose in patients with type I diabetes. The closed-loop system, Control-IQ, combines Tandem Diabetes Care’s t:slim X2 insulin pump with Dexcom’s G6 continuous glucose monitor. It is designed to automatically monitor blood glucose levels and adjust insulin delivery.
The Investigational Product
Control-IQ, made by Dexcom, includes an insulin pump within the system contains advanced control algorithms, which leverage a mathematical model, capturing the user’s glucose monitoring data to automatically adjust the insulin dose. This artificial pancreas system avoids the need for fingerstick testing and daily injections or a pump.
Classified International Diabetes Closed-Loop (iDCL), the multi-center, randomized six-month trial assessed five different artificial pancreas protocols at tend research centers in U.S. and Europe.
A Phase III study in a series of trials, it was performed to obtain insights into the working of the system in typical daily routines of 168 participants aged 14 years and above. During the study, Control-IQ was compared to a sensor-augmented pump (SAP) therapy using a GCM and insulin pump not designed to automatically adjust insulin.
Results revealed that the artificial pancreas system was more effective at controlling blood glucose levels associated with type 1 diabetes. Participants who used artificial pancreas experienced an average of 2.6 hours per day increase in the amount of time with their blood glucose levels in the 70-180mg/dL target range, while the time did not change in the SAP group over six months.
The artificial pancreas led to improvements in the time spent with high and low blood glucose, hemoglobin A1c and other diabetes control-related measurements versus the SAP group.
Tandem Diabetes Care, formed in 2006, is a public U.S. medical device manufacturer based in San Diego, CA. The company develops medical technologies for the treatment of diabetes and specifically insulin infusion therapy.
They have submitted the trial data to the U.S. Food and Drug Administration (FDA) seeking marketing approval for the Control-IQ system. In February, 2019 they announced that their CEO Kim Blickenstaff would transition to a newly created position of Executive Chairman and Board of Directors.
The company will generate about $281 million but will lose about $22 million. Their market capitalization is $3.7 billion—quite a robust premium.
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