Tandem Diabetes Care (Nasdaq:TNDM) announced that a study of adults with type 2 diabetes supported its automated insulin delivery system.
The study evaluated adults with type 2 diabetes using the t:slim X2 insulin pump with Control-IQ technology. Patients achieved improvement in all clinical endpoints with the technology, which currently does not hold approval for type 2 diabetes.
Data demonstrated safety during six weeks of use. It also presented substantial improvements in time in range and mean glucose related to a reduction in hyperglycemia. Tandem reported no increase in continuous glucose monitor (CGM)-measured hypoglycemia.
Both users of multiple daily injections (MDI) and basal insulin-only showed similar levels of improvement. According to a news release, participants indicated a high level of satisfaction with the Tandem system.
“Our goal with this study was to show Control-IQ technology was safe and could offer considerable benefit to individuals with type 2 diabetes, and we accomplished that,” said Dr. Carol Levy, protocol chair for the study and Professor of Medicine (Division of Endocrinology, Diabetes and Bone Disease) at the Icahn School of Medicine at Mount Sinai. “The 15 percent time in range improvement from prior therapy represents a 3.6 hour/day increase in time in range, with no hypoglycemia events.”
Mean time in range across all participants improved by 15% (3.6 hours per day) in the study. For prior MDI/pump users, time in range improved by 16%. In prior basal-only insulin users, the measurement improved by 13%.
The median time in closed-loop insulin delivery mode came in at 96%. The majority of participants, who indicated satisfaction, used additional glycemic therapies aside from insulin. They continued their use during the trial.
Tandem said the trial included 30 adults with type 2 diabetes from three clinical centers. Patients collected unblinded CGM data followed by an open-loop period before initiating Control-IQ use for six weeks.
“The results presented today are consistent with numerous studies that support the benefits of pump therapy to people who live with type 2 diabetes,” said Dr. Jordan Pinsker, VP and medical director for Tandem Diabetes Care. “People living with type 2 diabetes often take other medications in combination with their insulin therapy. The combination of safety outcomes and high satisfaction scores seen in this population, who were able to continue these existing medications during the study, shows that Control-IQ technology could be a powerful management solution for their therapy needs.”