Multicenter Evaluation of Ultra-Rapid Lispro Insulin with Control-IQ Technology in Adults, Adolescents, and Children with Type 1 Diabetes
Carol J. Levy, Ryan Bailey, Lori M. Laffel, Gregory P. Forlenza, Linda A. DiMeglio, Michael S. Hughes, Sue A. Brown, Grazia Aleppo, Anuj Bhargava, Viral N. Shah, Mark A. Clements, Mark Kipnes, Brittany Bruggeman, Mark Daniels, Henry Rodriguez, Peter Calhoun, John W. Lum, Ravid Sasson-Katchalski, Jordan E. Pinsker, Robyn K. Pollom, Roy W. Beck, for the TL1 Study Group
Abstract
Objective: To evaluate the safety and explore the efficacy of use of ultra-rapid lispro (URLi, Lyumjev) insulin in the Tandem t:slim X2 insulin pump with Control-IQ 1.5 technology in children, teenagers, and adults living with type 1 diabetes (T1D). Methods: At 14 U.S. diabetes centers, youth and adults with T1D completed a 16-day lead-in period using lispro in a t:slim X2 insulin pump with Control-IQ 1.5 technology, followed by a 13-week period in which URLi insulin was used in the pump. Results: The trial included 179 individuals with T1D (age 6–75 years). With URLi, 1.7% (3 participants) had a severe hypoglycemia event over 13 weeks attributed to override boluses or a missed meal. No diabetic ketoacidosis events occurred. Two participants stopped URLi use because of infusion-site discomfort, and one stopped after developing a rash. Mean time 70–180 mg/dL increased from 65% ± 15% with lispro to 67% ± 13% with URLi ( P = 0.004). Mean insulin treatment satisfaction questionnaire score improved from 75 ± 13 at screening to 80 ± 11 after 13 weeks of URLi use (mean difference = 6; 95% confidence interval 4–8; P < 0.001), with the greatest improvement reported for confidence avoiding symptoms of high blood sugar. Mean treatment-related impact measure-diabetes score improved from 74 ± 12 to 80 ± 12 ( P < 0.001), and mean TRIM-Diabetes Device (score improved from 82 ± 11 to 86 ± 12 ( P < 0.001). Conclusions: URLi use in the Tandem t:slim X2 insulin pump with Control-IQ 1.5 technology was safe for adult and pediatric participants with T1D, with quality-of-life benefits of URLi use perceived by the study participants. Clinicaltrials.gov registration: NCT05403502.