Tandem Diabetes Care Shares Positive Results from Study Evaluating Control-IQ Technology

Tandem Diabetes Care Inc., an insulin delivery and diabetes technology company, has shared results from a prospective, multicenter, single-arm study of adults living with type 2 diabetes who achieved improvement in all clinical endpoints with the use of the t:slim X2 insulin pump with Control-IQ technology.¹
 
Presented at the 22nd Annual Diabetes Technology Meeting, the data demonstrated the system to be safe during 6 weeks of use, with a substantial improvement in time in range and mean glucose related to a reduction in hyperglycemia and no increase in continuous glucose monitor (CGM)-measured hypoglycemia. Both prior multiple daily injection (MDI) users and prior basal insulin only users showed similar levels of improvement. Study participants indicated a high level of satisfaction with the 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 Carol Levy, MD, CDCES, 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.”
 
“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 Jordan Pinsker, MD, vice president 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.”

Primary Outcomes

Glycemic Control
 

• Use of Control-IQ technology was demonstrated to be safe during 6 weeks of use.
• Mean time in range across all participants improved 15 percentage points, an increase of 3.6 hours per day
• Mean time in range for prior MDI/pump users improved 16 percentage points
• Mean time in range for prior Basal-only insulin users improved 13 percentage points
• Mean Time >180 mg/dl improved 15 percentage points, which is a reduction of 3.6 hours per day
• Median time >250 improved 5.6 percentage points, which is a reduction of almost one hour per day
• No increase in CGM-measured hypoglycemia

 
System Performance and Usability
 

• Median time in closed loop was 96%
• Study participants indicated a high level of satisfaction with the system
• Majority of participants were using additional glycemic therapies other than insulin and continued their use during the trial

 
This multicenter, prospective trial included 30 adults with type 2 diabetes from three clinical centers: Icahn School of Medicine at Mount Sinai, New York City, NY; Mayo Clinic, Rochester, MN; and Texas Diabetes and Endocrinology, Austin, TX. The study was coordinated by the JAEB Center for Health Research, in Tampa, FL. Participants with type 2 diabetes (mean age 54±12 years, mean HbA1c 8.6±1.2, median BMI 31) using either MDI (N=15), pump (N=2), or basal without bolus insulin (N=13) collected unblinded CGM data (baseline) followed by an open-loop period prior to initiating use of Control-IQ technology for 6 weeks.
 
Control-IQ technology is not approved for use in individuals with type 2 Diabetes. This study was conducted with an investigational device exemption with a modified pump.
 
Reference:
¹ Levy CJ, Raghinaru D, Kudva Y, et al. Significant Reduction in Hyperglycemia and High Satisfaction with Use of Control-IQ Technology in Prior MDI and Basal Only Insulin Users with Type 2 Diabetes (T2D). Poster presented at 22nd Annual Diabetes Technology Meeting; November 10, 2022; Virtual.