Tandem Diabetes Care Reports Positive Results From Two Studies of the t slim X2 Insulin Pump With Control-IQ Technology
Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading insulin delivery and diabetes technology company, today announced positive results from two studies of the t:slim X2 insulin pump with Control-IQ advanced hybrid closed-loop technology. Data from both studies demonstrated that the system achieved the primary outcome of increasing time in range (70-180 mg/dL) without any severe hypoglycemic events. The t:slim X2 insulin pump with Control-IQ technology utilizes Dexcom G6 continuous glucose monitoring (CGM) sensor values to predict glucose levels and adjust insulin delivery to prevent highs and lows, while still allowing the user to manually bolus for meals. The system also automates correction boluses, which is a feature not commercially available today on automated insulin delivery devices.
Details from the two studies, which included Protocol 3 (DCLP3) of the National Institutes of Health (NIH)-funded International Diabetes Closed Loop (iDCL) trial and interim data from the Freelife Kid AP study, were presented today at the 79th Scientific Sessions of the American Diabetes Association (ADA) in a session moderated by Dr. Boris Kovatchev, Director of the Center for Diabetes Technology at the University of Virginia and principal investigator of the iDCL Trials. Presenters included Dr. Sue Brown, Associate Professor at the Center for Diabetes Technology at the University of Virginia and the endocrinologist who served as the protocol chair for this trial, and Dr. Eric Renard, Division Chief of Diabetic Medicine at University Hospital Center of Montpellier and the principal investigator for the Freelife Kid AP study.
International Diabetes Closed Loop Protocol-3 (DCLP3) Study Results
The NIH-funded DCLP3 study is the first large-scale, 6-month 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, 168 patients with type 1 diabetes ages 14 and up were randomized 2:1 to Control-IQ technology (n=112) or sensor-augmented pump (SAP) therapy (n=56) and followed for 26 weeks. The entry HbA1c for participants in the study ranged from 5.4 to 10.6 with a mean of 7.4 percent. Approximately 20 percent of participants were new to pump therapy and the large majority were already using a CGM. All participants completed the study.