San Diego-based Tandem won FDA clearance for its Control-IQ+ next-generation algorithm for type 2 diabetes at the end of last month. Just yesterday, the company announced the launch of the algorithm. Control-IQ+ represents the next generation of the company’s advanced hybrid closed-loop insulin delivery algorithm. It has compatibility with both the company’s pump offerings, the t:slim X2 and Mobi pumps.
Findings were published in the The New England Journal of Medicine (NEJM). Investigators presented additional study findings today at the 18th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) in Amsterdam.
Results published in NEJM highlighted significant improvements in time in range and A1C in people with type 2 diabetes. The study compared users of Control-IQ+ technology to a control group that continued their pre-study insulin delivery method while using a CGM.
Investigators observed a 0.9% reduction in A1C for people using Control-IQ+ (215 subjects) compared to 0.3% in the control (104). People who entered the study with an A1C of 9% or higher recorded a 2.3% A1C reduction with Control-IQ+. The company said the results spanned a socioeconomically diverse population between 19 and 87 years of age. Both groups used a Dexcom G6 CGM for the duration of the study.
“The benefits of Control-IQ+ technology were evident across an incredibly diverse population, regardless of pre-study glycemic control or experience with diabetes technology. In fact, those with low and high numeracy scores at baseline did equally as well, suggesting that the technology was simple to use regardless of education level or their general understanding of diabetes,” said Jordan Pinsker, MD, chief medical officer at Tandem Diabetes Care. “These results underscore the potential of this technology to improve outcomes for people living with type 2 diabetes who use insulin, while helping alleviate daily therapy burden and improve quality of life.”
More about the Tandem Diabetes Care study
The 13-week study had a primary outcome of evaluating change in A1C with Control-IQ+ in adults 18 and older with type 2 diabetes. Additional outcomes included changes in CGM-measured time in range, time in hyperglycemia/hypoglycemia and safety events. Those include severe hypoglycemia, diabetic ketoacidosis and other serious adverse events.
Tandem said its study included data from 319 patients across 21 clinical centers in the U.S. and Canada. It called the study population “one of the most diverse studies of AID technology in type 2 diabetes.” Out of all subjects, 39% identified as minority race or ethnicity, including 22% Black and 11% Hispanic. Nearly half (44%) also used a stable dose of a GLP-1 receptor agonist and 37% were on a stable dose of an SGLT-2 inhibitor, which they continued throughout the study. 40% used more than 100 units of insulin per day, and only 4% were using an insulin pump at baseline.
The company says that, importantly, participants came into the study with varied insulin regimens.
Among many outcomes, including the A1C decrease, time in range improved by 16%. Control-IQ+ resulted in 3.8 more hours/day in range than baseline and 3.4 more hours/day in range than the control. Insulin use decreased by 8 units/day in the Control-IQ+ group, compared to 2 units/day in the CGM group.
Tandem reported no new safety signals unique to type 2 diabetes users compared to previous studies of type 1 patients. Both groups had low hypoglycemia frequency, while one severe hypoglycemic event occurred in the Control-IQ+ group. That was successfully treated with oral carbohydrates. The study also saw no DKA or hyperosmolar hyperglycemic syndrome events.
Dr. Roy W. Beck, who coordinated the study, said it represents “the most rigorous evaluation of automated insulin delivery technology for people with type 2 diabetes ever conducted.”
Beck said results highlighted the benefits of Control-IQ+ in type 2 diabetes. He also noted encouraging results for those using insulin plus a GLP-1 drug.
Other data shared at ATTD
Tandem also shared data related to bolus behavior and system usability and satisfaction at ATTD.
The study permitted different bolusing strategies, including the use of a carbohydrate calculator or entering a set amount of carbohydrate or units of insulin for small, medium, and large meals. Three-quarters of participants were not performing carbohydrate counting at enrollment.
All bolus strategies proved effective with Control-IQ+, resulting in similar, significant A1C reductions across groups. Those who used fewer user-initiated boluses received a high percent of their insulin through Control-IQ+-moderated insulin delivery also did well. Investigators saw no increase in hypoglycemia between bolusing methods.
For usability. patient-reported outcomes related to device satisfaction and sleep quality improved significantly with Control-IQ+ compared to the CGM group at the end of the study. Control-IQ+ received high usability scores regardless of bolusing strategy.
