Positive results were announced this week from the study of a new insulin pump with a predictive low glucose suspend (PLGS) feature. Data showed that the system achieved the primary outcome of reducing time spent in hypoglycemia compared to sensor-augmented pump therapy alone. The company developing the device, Tandem Diabetes Care, is marketing its new pump as the the t:slim X2™ Insulin Pump with Basal-IQ technology. Details from the study were presented at the 11th Annual Conference on Advanced Technologies and Treatments for Diabetes (ATTD) in Vienna, Austria by Bruce Buckingham, MD, professor of Pediatric Endocrinology at Stanford University, and principal investigator of the PROLOG (PLGS for Reduction Of LOw Glucose) trial.
The t:slim X2 Insulin Pump with Basal-IQ technology utilizes Dexcom G5® Mobile Continuous Glucose Monitoring (CGM) sensor values to suspend insulin delivery when low blood glucose is predicted and automatically resume insulin delivery when glucose levels begin to rise. Use of the system during a three-week period at home reduced the number of sensor glucose readings below 70 mg/dL by 31 percent compared to the control period using a standard CGM-integrated t:slim X2 Pump without automated insulin suspension. Importantly, this marked reduction of time spent in low glucose was accomplished without any increase in the rate of hyperglycemia.
“Tandem’s t:slim X2 Insulin Pump with Basal-IQ proved easy to use, reduced time spent in hypoglycemia and improved time in range. These results are especially impressive given the study participants started out very well controlled, with a mean hemoglobin A1c of 7.3 percent. Participants also reported a high level of confidence using the system without a significant training burden to get started,” says Greg Forlenza, MD, principal investigator for the University of Colorado Barbra Davis Center study site. “With increased availability and patient use of automated insulin delivery systems, we expect to see improvements in short term complications such as hypoglycemia, and a decrease in patients’ daily burden of diabetes and long-term complications.”
About the PROLOG Study
The PROLOG study was a multi-center, randomized crossover clinical trial comparing two three-week periods of at-home insulin pump use, one period using the t:slim X2 Pump with PLGS, and another period using a standard CGM-integrated t:slim X2 Pump without automated insulin suspension. The study included 103 participants with type 1 diabetes age 6 to 72 at four research centers across the United States and was coordinated by the Jaeb Center for Health Research in Tampa, Florida. The mean A1C of participants entering the study was 7.3 percent, with the majority already using a pump (83%) and/or CGM (84%). The primary endpoint of the study was to demonstrate a reduction in the percentage of CGM values below 70 mg/dL when using Tandem’s PLGS feature.
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