The DCLP5 study is a 16-week closed-loop study that included a dedicated control group, increasing the clinical significance of the study results
Tandem Diabetes Care, 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.
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.
“We are excited to see the outcome of 15 years of research, and have a lot of people to thank for it, including Benton Mize, Antoine Robert, Patrick Keith-Hines, Stephen Patek, Colin Steele, and Chad Rogers at Type Zero Technologies, who were instrumental in transitioning the system from academia to the commercial application,” said Dr. Breton. “After the resounding success of the system in adolescents and adults last year in the DCLP3, it is very rewarding to see our younger participants in the DCLP5 benefit as well, and to the same extent.”
Source: Company Press Release