Multicenter Evaluation of Ultra-Rapid Lispro Insulin with Control-IQ Technology in Adults, Adolescents, and Children with Type 1 Diabetes.
Document Type
Article
Publication Date
9-2024
Identifier
DOI: 10.1089/dia.2024.0048
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.
Journal Title
Diabetes technology & therapeutics
Volume
26
Issue
9
First Page
652
Last Page
660
MeSH Keywords
Humans; Diabetes Mellitus, Type 1; Adolescent; Insulin Lispro; Male; Female; Child; Hypoglycemic Agents; Insulin Infusion Systems; Adult; Middle Aged; Young Adult; Blood Glucose; Aged; Hypoglycemia; Glycated Hemoglobin; Quality of Life; Patient Satisfaction; Treatment Outcome
Keywords
adults; hybrid closed-loop systems; pediatrics; ultrafast-acting insulin analogs
Recommended Citation
Levy CJ, Bailey R, Laffel LM, et al. Multicenter Evaluation of Ultra-Rapid Lispro Insulin with Control-IQ Technology in Adults, Adolescents, and Children with Type 1 Diabetes. Diabetes Technol Ther. 2024;26(9):652-660. doi:10.1089/dia.2024.0048
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