SAN DIEGO--(BUSINESS WIRE)-- Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading insulin delivery and diabetes technology company, today announced publication of results from the Pediatric Artificial Pancreas (PEDAP) Clinical Trial by the New England Journal of Medicine showing an approximate 3-hour per day increase in time in range* in children ages 2-5 years old using the t:slim X2 insulin pump with Control-IQ advanced hybrid closed-loop technology** compared to those on a standard insulin pump or multiple daily injections. All participants were using a Dexcom G6 Continuous Glucose Monitoring (CGM) System.
Results observed in this randomized, controlled trial for subjects using Control-IQ technology, an automated insulin delivery (AID) system, were immediate, sustained, and observed across the spectrum of patient characteristics including race-ethnicity, parental education, family income, baseline glycated hemoglobin level, virtual vs. in-person training format, and pre-study insulin delivery method. Subjects with higher baseline hemoglobin A1c values (A1c) experienced greater improvements in time in range and A1c during the study.
“The safety and efficacy outcomes observed in this study support using Control-IQ technology for young children with type 1 diabetes to enhance quality of life and minimize the risk of long-term complications,” said Dr. R. Paul Wadwa, Professor of Pediatrics at the Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus and protocol chair for the PEDAP Clinical Trial. “Studies using Control-IQ technology have shown impressive results in different age groups, now in a sequence of randomized controlled trials published by the New England Journal of Medicine, demonstrating more time in range with low risk of hypoglycemia.”
“After the resounding success of Control-IQ technology in people ages six and up, it is very rewarding to see our youngest patients, and often the most challenging patients to help, benefit as well,” 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 PEDAP study. “With these results, we have now accumulated years of clinical validation of this system across all age groups and look forward to seeing this life changing technology made available to the broadest possible population.”
“Use of the t:slim X2 insulin pump with Control-IQ technology demonstrated substantial improvements in glucose control, particularly overnight, with no increase in hypoglycemia in young children,” said Jordan Pinsker, MD, Vice President and Medical Director at Tandem Diabetes Care. “Initiating pump therapy with automated insulin delivery can be very daunting for parents. A system offering these clinical benefits that is simple enough to start with virtual training makes the t:slim X2 insulin pump an excellent therapeutic option for this population.”
Key Data Highlights
Glycemic Control Over 13 Weeks
- Mean time in range with Control-IQ technology increased from 57 percent at baseline to 69 percent during follow-up compared to 55 percent to 56 percent in the control group, for a mean adjusted difference of 12.4 percent.
- Hemoglobin A1c decreased 0.5 percent from baseline with Control-IQ technology, a median improvement of 0.42 percent compared to the control group.
- Time spent in hyperglycemia (>250 mg per deciliter) was 5.4 percentage points less with Control-IQ technology than the control group.
- Time spent in hypoglycemia (