Multicenter Evaluation of Ultra-Rapid Lispro Insulin with Control-IQ Technology in Adults, Adolescents, and Children with Type 1 Diabetes.

Autor: Levy CJ; Division of Endocrinology, Icahn School of Medicine at Mount Sinai, New York City, New York, USA., Bailey R; Jaeb Center for Health Research, Tampa, Florida, USA., Laffel LM; Research Division, Joslin Diabetes Center and Department of Pediatrics, Harvard Medical School, Boston, Massachusetts, USA., Forlenza G; Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora, Colorado, USA., DiMeglio LA; Department of Pediatrics, Division of Pediatric Endocrinology and Diabetology, Indiana University School of Medicine, Indianapolis, Indiana, USA., Hughes MS; Department of Medicine, Division of Endocrinology, Gerontology and Metabolism, Stanford University School of Medicine, Stanford, California, USA., Brown SA; Division of Endocrinology, Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia, USA., Aleppo G; Division of Endocrinology, Metabolism and Molecular Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA., Bhargava A; Iowa Diabetes and Endocrinology Research Center, West Des Moines, Iowa, USA., Shah VN; Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora, Colorado, USA., Clements MA; Department of Pediatrics, Division of Endocrinology and Diabetes, Children's Mercy Kansas City, Kansas City, Missouri, USA., Kipnes M; Diabetes & Glandular Disease Clinic, San Antonio, Texas, USA., Bruggeman B; Department of Pediatrics, Division of Endocrinology, University of Florida, Gainesville, Florida, USA., Daniels M; Division of Endocrinology and Diabetes, Children's Hospital of Orange County, Orange, California, USA., Rodriguez H; USF Diabetes and Endocrinology Center, University of South Florida, Tampa, Florida, USA., Calhoun P; Jaeb Center for Health Research, Tampa, Florida, USA., Lum JW; Jaeb Center for Health Research, Tampa, Florida, USA., Sasson-Katchalski R; Tandem Diabetes Care, San Diego, California, USA., Pinsker JE; Tandem Diabetes Care, San Diego, California, USA., Pollom R; Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana, USA., Beck RW; Jaeb Center for Health Research, Tampa, Florida, USA.
Jazyk: angličtina
Zdroj: Diabetes technology & therapeutics [Diabetes Technol Ther] 2024 Sep; Vol. 26 (9), pp. 652-660. Date of Electronic Publication: 2024 May 22.
DOI: 10.1089/dia.2024.0048
Abstrakt: 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.
Databáze: MEDLINE