SAN DIEGO--(BUSINESS WIRE)-- Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading insulin delivery and diabetes technology company, today announced publication by the New England Journal of Medicine (NEJM) of results from the landmark Protocol 3 study (DCLP3) of the National Institutes of Health (NIH)-funded International Diabetes Closed Loop (iDCL) trial using the t:slim X2™ insulin pump with Control-IQ™ advanced hybrid closed-loop technology. The DCLP3 study was the first-ever large-scale, six-month closed-loop study that included a dedicated control group. Over the six-month study period, use of Control-IQ technology led to a higher percentage of time spent in range (70-180 mg/dL), less hyper- and hypoglycemia and better HbA1c levels than use of a sensor augmented pump. No severe hypoglycemic events were reported, and 100 percent of participants completed the study. The article was published today on the journal website, NEJM.org, and will appear in the October 31, 2019 printed issue.
The t:slim X2 insulin pump with Control-IQ technology, currently under review by the U.S. Food and Drug Administration (FDA), utilizes Dexcom G6 continuous glucose monitoring (CGM) sensor values to predict glucose levels 30 minutes ahead and adjust insulin delivery to help prevent highs and lows, while still allowing the user to manually bolus for meals. The system also delivers automatic correction boluses, which is a feature not commercially available today on automated insulin delivery devices.
“This NEJM publication recognizes the importance and rigor of the landmark DCLP3 study and the robustness of the safety and efficacy data behind the t:slim X2 insulin pump with Control-IQ technology,” said John Sheridan, president and CEO of Tandem Diabetes Care. “These outcomes, combined with the overwhelmingly positive experiences reported by trial participants, give us confidence that availability of Control-IQ technology will further our mission to improve the lives of people with diabetes, and we continue to prepare for its commercial launch this year, pending FDA approval.”
“We are thrilled with the results published today and proud of the role Dexcom played in the DCLP3 study,” said Kevin Sayer, Chairman, President and Chief Executive Officer at Dexcom. “Consistent use and exceptional sensor accuracy are critical components for optimized glucose control in an advanced hybrid closed loop system. As the study’s greater than 90 percent average time in closed loop demonstrates, Dexcom’s G6 excels on both of these fronts. The integration of Control-IQ technology with Dexcom’s G6 has proven to be a powerful combination for automated insulin delivery.”
Key Data Highlights
Glycemic Control over Six Months
- Time in range (70 mg/dL – 180 mg/dL) increased from 61 percent at baseline to 71 percent using Control-IQ technology. The control group using sensor-augmented pump therapy alone, remained unchanged at 59 percent (p