Data from a Tandem Diabetes Care (Nasdaq:TNDM) study demonstrated the benefits of its automated insulin delivery technology.
Diabetes Technology & Therapeutics made data available from the Control-IQ Observational (CLIO) study. It’s the largest prospective study of the Control-IQ advanced hybrid closed-loop technology to date. Twelve-month results showed, among other results, lower adverse events for type 1 diabetes patients using the technology.
Tandem Diabetes Care develops automated insulin delivery products, including its flagship t:slim X2 pump with Control-IQ technology. The company last month won FDA clearance for its Mobi automated insulin delivery system, which is less than half the size of the t:slim X2.
Control-IQ technology automatically observes and manages blood glucose levels. This artificial pancreas employs an insulin pump that uses sophisticated algorithms based on glucose monitoring data from the Dexcom G6 CGM, adjusting insulin dosage as required. The FDA has cleared Control-IQ for use in individuals aged 6 and older with type 1 diabetes.
In the study, Control-IQ led to lower observed rates for both severe hypoglycemia and diabetic ketoacidosis across all demographics. Adult participants, on average, achieved greater than 70% time in range, with pediatric participants topping 60% CGM time in range.
The study also observed a reduction in adverse events independent of baseline HbA1c, prior insulin therapy or prior CGM experience. Tandem says the lowest rate was most pronounced for people switching from multiple daily injections. It demonstrated the benefits of the technology even for those who didn’t previously consider pump therapy.
Tandem set up the study as a single-arm, prospective, longitudinal post-market surveillance. It evaluated individuals ages six and up with type 1 diabetes using Control-IQ technology in a real-world setting. In total, 2,998 subjects completed the surveillance at 12 months. All study visits took place virtually, increasing accessibility for participation to a broader range of people.