Tandem Diabetes Care Announces Control-IQ Technology Meta-analysis Demonstrating Positive Clinical Impact of Automatic Correction Bolusing on Glucose Control in People with Type 1 Diabetes

SAN DIEGO--(BUSINESS WIRE)-- Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading insulin delivery and diabetes technology company, today 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 (CGM) 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 (n=256) 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 (n=113) used an insulin pump (91%), some with predictive low glucose suspend technology.

“Control-IQ technology delivered the most robust improvements in those entering the study with the highest hemoglobin A1c and lowest time in range,” said Roy W. Beck, MD, PhD, Executive Director of the Jaeb Center for Health Research. “The high number of automatic boluses given by the system in this group likely reflect previously missed meal boluses or lack of manual correction boluses when on conventional therapy and demonstrates the substantial impact Control-IQ technology’s auto-bolusing feature can have for people struggling on a standard pump or multiple daily injections.”

“All subgroups in these studies, regardless of age, ethnicity, education, or previous pump experience, benefited from Control-IQ technology,” said Boris Kovatchev, PhD, Director of the Center for Diabetes Technology at the University of Virginia. “It is clear from these results, which are consistent with real-life data from thousands of current Control-IQ technology users, that this technology should be considered as an option for anyone living with type 1 diabetes.”

“With three randomized, controlled trials completed, Control-IQ technology has the most robust data set supporting its benefits compared to any other automated insulin delivery system available today,” said Jordan Pinsker, MD, Vice President and Medical Director at Tandem Diabetes Care.

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 (>250 mg/dL) 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 (