Tandem Diabetes Care announces publication of meta-analysis of Control-IQ trials

Tandem Diabetes Care announced publication by Diabetes Technology & Therapeutics of a meta-analysis of three randomized controlled trials of its Control-IQ advanced hybrid closed-loop technology. Results demonstrate the positive clinical impact of the system’s automatic correction bolusing on glucose control across a wide range of ages and demographics of people living with type 1 diabetes. People with the highest baseline blood sugar levels experienced the greatest benefit from the auto-bolus feature of the Control-IQ algorithm. Automatic correction bolusing is an automated insulin dosing feature that is only commercially available in the t:slim X2 insulin pump with Control-IQ technology. All participants were using a Dexcom G6 Continuous Glucose Monitoring System. The analysis showed an average increase in time in range of 2.8 hours and a reduction in hemoglobin A1c compared to control groups in people ages 2 to 72 years old. Improvements in time in range for subjects using Control-IQ technology were immediate, sustained, and observed across the spectrum of patient characteristics including age, race-ethnicity, parental education, family income, baseline glycated hemoglobin level, virtual vs. in-person training format, and pre-study insulin delivery method. The majority of the control group used an insulin pump, some with predictive low glucose suspend technology. Additional Data Highlights: Glycemic Control at 3 Months: Mean time in range with Control-IQ technology increased from 57 percent at baseline to 70 percent during follow-up compared to 56 percent to 57 percent in the control group, for a mean adjusted difference of 11.5 percent. Hemoglobin A1c decreased from 7.5 percent at baseline to 7.0 percent for the Control-IQ technology group, with an adjusted improvement of 0.38 percent compared to the control group. Substantial daytime and nighttime reductions in hyperglycemia and mean glucose were seen with Control-IQ technology compared with the control group. The greatest difference in mean glucose was between 4am and 8am. Time spent in hypoglycemia was low at baseline, but reductions in time less than70 mg/dL and less than54 mg/dL were still observed with Control-IQ technology compared with the control group. The rate of severe hypoglycemia events was exceedingly low and similar between Control-IQ technology and the control group. System Performance and Useability: Fewer user-initiated boluses were associated with people age 14 to 24 years and those with a baseline hemoglobin A1c of 8 percent or higher. Fifty percent or more of the total number of daily boluses for these two groups were automated. The median time the system was in active closed loop was 93 percent. Results were observed regardless of pre-study experience with an insulin pump.