Tandem reports results from studies of t:slim X2 insulin pump with Control-IQ
Tandem Diabetes announced results from two studies of the t:slim X2 insulin pump with Control-IQ advanced hybrid closed-loop technology. Data from both studies demonstrated that the system achieved the primary outcome of increasing time in range without any severe hypoglycemic events. The t:slim X2 insulin pump with Control-IQ technology utilizes Dexcom G6 continuous glucose monitoring sensor values to predict glucose levels and adjust insulin delivery to prevent highs and lows, while still allowing the user to manually bolus for meals. The system also automates correction boluses, which is a feature not commercially available today on automated insulin delivery devices. Details from the two studies, which included Protocol 3 of the National Institutes of Health-funded International Diabetes Closed Loop trial and interim data from the Freelife Kid AP study, were presented at the 79th Scientific Sessions of the American Diabetes Association. The NIH-funded DCLP3 study is the first large-scale, 6-month closed-loop study that included a dedicated control group, increasing the clinical significance of the study results. There were no exclusion criteria based on hemoglobin A1c, history of acute complications, or previous experience using an insulin pump or CGM. Following a two to eight-week run-in period, the length of which was determined based on previous pump and CGM experience, 168 patients with type 1 diabetes ages 14 and up were randomized 2:1 to Control-IQ technology or sensor-augmented pump therapy and followed for 26 weeks. The entry HbA1c for participants in the study ranged from 5.4 to 10.6 with a mean of 7.4%. Approximately 20% of participants were new to pump therapy and the large majority were already using a CGM. All participants completed the study. The Freelife Kid AP study is a multi-center, randomized assessment of the efficacy of closed-loop insulin therapy in prepubertal children, comparing nocturnal and 24-hour use of Control-IQ technology over 18 weeks, followed by an 18-week extension. The completed study, taking place in France, is expected to include 120 participants with type 1 diabetes ages 6 to 12 years old. An interim analysis was planned after 12 weeks from the first 30 included subjects to assess percent of time in closed-loop mode, incidence of any severe adverse events and efficacy measures based on CGM data. The t:slim X2 insulin pump with Control-IQ technology utilizes Dexcom G6 CGM sensor values to predict glucose levels 30 minutes ahead and adjust insulin delivery to help prevent highs and lows, while still allowing the user to manually bolus for meals. The system also automates correction boluses, which is a feature not commercially available today on automated insulin delivery devices.