A pivotal trial funded by the National Institutes of Health found that an artificial pancreas system from Tandem Diabetes Care (NSDQ:TNDM) was more effective than existing treatments for people with Type 1 diabetes.
The Tandem system combines its t:slim X2 insulin pump and Control-IQ advanced hybrid closed-loop technology with a continuous glucose monitor made by DXCM, the recently approved G6 CGM. Control-IQ is designed to predict glucose levels 30 minutes ahead and adjust insulin delivery accordingly. Results from the study, which was funded by NIH’s National Institute of Diabetes & Digestive & Kidney Diseases, were published in the New England Journal of Medicine.
The trial randomly assigned 168 Type 1 patients ages 14 or older to either the Tandem device or treatment with the G6 CGM and another insulin pump that did not automatically adjust insulin. Patients in the Control-IQ arm increased the amount of time in glucose level range (70-180 mg/dL) by an average of 2.6 hours a day and showed improvements in time spent with high and low blood glucose, hemoglobin A1c and other measures compared to the control group.
No severe hypoglycemia events were observed in either group, but diabetic ketoacidosis occurred in a Control-IQ patient due to a problem with the equipment that delivered insulin. A previous problem with the Control-IQ’s handling of CGM data, which temporarily halted use of the software, was resolved in March.
“Testing the safety and effectiveness of new technologies in real-world settings is critical to prove the usability of these systems by people with diabetes to achieve a better daily control of their blood glucose levels,” NIDDK diabetes technology program director Dr. Guillermo Arreaza-Rubín said in prepared remarks. “Earlier technologies have made the management of Type 1 diabetes easier, and this research shows that this artificial pancreas system has the potential to improve the health of people living with Type 1 diabetes, while also potentially lifting much of the burden of care from those with the disease and their caregivers.”
“This artificial pancreas system has several unique features that improve glucose control beyond what is achievable using traditional methods,” added director of the University of Virginia center for diabetes Boris Kovatchev. “In particular, there is a special safety module dedicated to prevention of hypoglycemia, and there is gradually intensified control overnight to achieve near-normal blood sugar levels every morning.”
“This NEJM publication recognizes the importance and rigor of the landmark DCLP3 study and the robustness of the safety and efficacy data behind the t:slim X2 insulin pump with Control-IQ technology,” Tandem Diabetes Care president & CEO John Sheridan said in a separate release. “These outcomes, combined with the overwhelmingly positive experiences reported by trial participants, give us confidence that availability of Control-IQ technology will further our mission to improve the lives of people with diabetes, and we continue to prepare for its commercial launch this year, pending FDA approval.”
Shares of TNDM were up 1.5% at $60.20 per share in early-morning trading today.