Data Presented at International Diabetes Conference Further Demonstrate Benefits of Tandem Diabetes Care Automated Insulin Delivery Technologies

Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading insulin delivery and diabetes technology company, announced positive data presented today on its automated insulin delivery technologies, including data from a study of the t:slim X2 insulin pump with Control-IQ advanced hybrid closed-loop technology demonstrating increased time in range (70 mg/dL -180 mg/dL) ¹ in children ages six to thirteen. In a separate presentation, real-world data was presented on the t:slim X2 insulin pump with Basal-IQ predictive low glucose technology, showing sustained reductions in sensor time spent below 70 mg/dL and improvements in user satisfaction compared to previous therapy. Data was presented during a corporate symposium at the 13th International Conference on Advanced Technologies and Treatments for Diabetes (ATTD) in Madrid, Spain.

“These results align with our vision to establish Tandem as a global company that provides easy-to-use insulin therapy management solutions for improved clinical outcomes to children and adults living with diabetes,” said John Sheridan, president and chief executive officer. “In support of this goal, we plan to submit a regulatory filing with the FDA next month to expand the age indication for t:slim X2 with Control-IQ technology to include patients 6 years of age and older.”

Control-IQ Advanced Hybrid Closed Loop Technology Data

International Diabetes Closed Loop Protocol-5 (DCLP5) Study Results

Details from the Protocol 5 (DCLP5) of the National Institutes of Health (NIH)-funded International Diabetes Closed Loop (iDCL) program, an international consortium of academic centers led by the University of Virginia, were presented by Dr. R. Paul Wadwa, Associate Professor of Pediatrics, at the Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, and the protocol chair for this trial.

“This study demonstrated that in school-aged children with type 1 diabetes, who often struggle with diabetes management for a variety of reasons, use of Control-IQ technology led to improved glucose control during both the day and night,” said Dr. Wadwa. “We are thrilled with these results and are hopeful that this system will ultimately offer a valuable treatment option to benefit children with type 1 diabetes.”

The DCLP5 study is a 16-week 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 (HbA1c), 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, 101 patients with type 1 diabetes ages 6 to 13 were randomized 3:1 to Control-IQ technology (n=78) or sensor-augmented pump (SAP) therapy (n=23) and followed for 16 weeks. The entry HbA1c for participants in the study ranged from 5.7 to 10.1 with a mean of 7.9 in the SAP group and 7.6 in the Control-IQ technology group. Approximately 20 percent of participants were new to pump therapy and the large majority were already using a CGM. All participants completed the study.