Data Presented at International Diabetes Conference Further Demonstrate Benefits of Tandem Diabetes Care Automated Insulin Delivery Technologies - Seite 2

Time in range (70 mg/dL – 180 mg/dL)¹ for children using Control-IQ technology for 6 months increased from 53 percent to 67 percent, compared to those in the control group who increased from 51 percent to 55 percent using SAP alone (p<0.001). During the overnight period, sensor time in range with Control-IQ technology was 80 percent compared to 54 percent in the control group.

Time spent with sensor glucose values above 180 mg/dL was 31 percent in those using Control-IQ technology compared to 43 percent in the control group (p<0.001). Sensor time spent below 70 mg/dL was very low at baseline (<2 percent in both treatment groups) and not different between groups at the 16-week follow up interval. These results were demonstrated in people with and without prior experience with insulin pump therapy. The treatment effect was evident in the first month and appeared consistent over 4 months. In addition to sensor time in range, those using Control-IQ technology also saw statistically significant reductions in mean sensor glucose.

No severe hypoglycemia or diabetic ketoacidosis (DKA) was reported in the study. The system operated in active closed-loop 93 percent of the 4-month time period.

International Diabetes Closed Loop Protocol-3 (DCLP3) Study Results

A review of the evolution of Control-IQ technology, and a summary of available Control-IQ clinical data was presented by Dr. Marc Breton, the Associate Director of Research for The Center for Diabetes Technology at the University of Virginia, and the Principal Investigator of the DCLP5 study. In addition, Dr. Breton presented details from the National Institutes of Health (NIH)-funded International Diabetes Closed Loop (iDCL) trial, Protocol 3 (DCLP3) in adults and adolescents.

The NIH-funded DCLP3 study was the first large-scale, 6-month closed-loop study that included a dedicated control group. There were no exclusion criteria based on hemoglobin A1c (HbA1c), history of acute complications, or previous experience using an insulin pump or CGM. Time in range (70 mg/dL – 180 mg/dL)¹ for participants using Control-IQ technology for 6 months averaged 71 percent compared to 59 percent for participants in the control group using SAP alone (p<0.0001). During the overnight period, sensor time in range with Control-IQ technology averaged 76 percent compared to 59 percent in the control group (p<0.0001). Time spent with sensor glucose values above 180 mg/dL was 27 percent in those using Control-IQ technology compared to 39 percent in the control group (p<0.001). Sensor time spent below 70 mg/dL was 1.4 percent with Control-IQ technology compared to 1.9 percent in the control group (p<0.001), and sensor time spent below 54 mg/dL was 0.21 percent compared to 0.24 percent in the control group (p=0.02). These results were demonstrated in participants with and without prior insulin pump therapy experience. In addition to sensor time in range, those using Control-IQ technology also saw statistically significant improvements in HbA1c and reductions in mean glucose. One report of diabetic ketoacidosis (DKA) was reported in the Control-IQ study arm due to an infusion set issue. No severe hypoglycemia was reported in the study.