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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 Protocol 5 study (DCLP5) of the International Diabetes Closed Loop (iDCL) trial. Results demonstrated increased time spent in range (70-180 mg/dL) in children ages 6 to 13 years old using the t:slim X2™ insulin pump with Control-IQ™ advanced hybrid closed-loop technology. The article was published on August 27, 2020 and is available on the journal website, www.NEJM.org.
The DCLP5 study was the first-ever large-scale, closed-loop pediatric study that included a dedicated control group. Over the four-month study period, use of Control-IQ technology led to a higher percentage of time spent in range (70-180 mg/dL) and less hyperglycemia than the control group. The control group used either a sensor augmented pump without automated insulin dosing or Tandem’s t:slim X2 pump with Basal-IQ® predictive low glucose suspend technology. No severe hypoglycemia or diabetic ketoacidosis was reported, and 100 percent of participants using Control-IQ technology completed the study.
"We are thrilled with the benefits observed in this study in school-aged children with type 1 diabetes, a population that often struggles with diabetes management for a variety of reasons,” said Dr. R. Paul Wadwa, Professor of Pediatrics, at the Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, and the protocol chair for this trial. "Control-IQ technology proved very easy to use for children and their parents and led to improved glucose control during both the day and night.”
"After the resounding success of the system in adolescents and adults in the previous DCLP3 study, it is very rewarding to see younger participants in the DCLP5 benefit as well, and to the same extent,” said Dr. Marc Breton, the Associate Director for Research of The Center for Diabetes Technology at the University of Virginia, and the Principal Investigator of the DCLP5 study. "We are excited to see the results of 15 years of research acknowledged once more by NEJM.”
The t:slim X2 insulin pump with Control-IQ technology 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, a first for commercial automated insulin delivery systems. The t:slim X2 insulin pump with Control-IQ technology, originally approved for ages 14 and older, received U.S. Food and Drug Administration clearance for use in ages six and older in June 2020. The t:slim X2 pump with Control-IQ technology also recently launched in select geographies outside the United States.
"The safety and efficacy data from the DCLP5 study featured in this NEJM publication, coupled with the positive experiences reported to us by younger Control-IQ users and their families, exemplifies our commitment to our mission to improve the lives of people with diabetes,” said John Sheridan, president and CEO of Tandem Diabetes Care.
"The integration of Control-IQ technology with Dexcom G6 has proven to be an incredibly effective combination for automated insulin delivery. We are thrilled with the pediatric results published today and proud of the role Dexcom played in the DCLP5 study,” said Kevin Sayer, chairman, president and CEO of Dexcom.
Key Data Highlights
Glycemic Control over Four Months
Time in range (70 mg/dL – 180 mg/dL) increased from 53 percent at baseline to 67 percent in participants using Control-IQ technology, the equivalent of 3.4 more hours per day. The control group demonstrated an increase from 51 percent to 55 percent.
Time in range at night (midnight to 6:00 a.m.) was 80 percent using Control-IQ technology compared to 54 percent in the control group.
Mean glucose was significantly lower in participants using Control-IQ technology (162 vs. 179 in the control group, p
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