Ultrarapid lispro demonstrates similar time in target range to lispro with a hybrid closed-loop system Journal Article uri icon
Overview
abstract
  • Background: Automated insulin delivery systems are associated with improved glycemic outcomes for patients with diabetes. Ultrarapid lispro (URLi), which has an accelerated pharmacokinetic profile and shows superior postprandial glucose control compared to lispro (Humalog(庐)), is a potential candidate for use in these systems. Methods: In this double-blind, crossover trial over two 4-week treatment periods, we evaluated URLi in a hybrid closed-loop system using the Medtronic MiniMed鈩� 670G system (670G). After a 2-week lead-in on lispro, 42 adults with type 1 diabetes were randomized to 1 of 2 treatment sequences of URLi and lispro delivered via the 670G. Primary endpoint was the percentage of time with glucose values within target range 3.9-10.0鈥塵mol/L (70-180鈥塵g/dL; %TIR). Results: Both treatments achieved %TIR over the 24-h period that was above the 70% minimum recommended by the International Consensus Guidance: URLi, 77.0%; lispro, 77.8%; P鈥�=鈥�0.339. %Time <3.0鈥塵mol/L (54鈥塵g/dL) was similar between treatments (URLi, 0.3%; lispro, 0.4%; P鈥�=鈥�0.548) and %time <3.9鈥塵mol/L (70鈥塵g/dL) was lower with URLi (1.5%) versus lispro (2.2%); P鈥�=鈥�0.009, while %time >10.0鈥塵mol/L (180鈥塵g/dL) was higher with URLi (21.5% [309.4鈥塵in] vs. 19.9% [287.2鈥塵in]; P鈥�=鈥�0.088). Mean sensor glucose was significantly higher with URLi versus lispro with least squares mean difference of 0.17鈥塵mol/L or 3.0鈥塵g/dL (P鈥�=鈥�0.011) between treatments. Insulin dose, %time in Auto Mode per week, and pump settings were similar between treatments. No serious adverse events (AEs) (including severe hypoglycemia) or discontinuations occurred, and the incidence of treatment-emergent AEs was similar between treatments. Although the overall incidence and rate of unplanned infusion set changes were similar between treatments, a significantly higher rate of unplanned infusion set changes due to infusion site reactions was seen during URLi treatment compared with lispro: 0.12 versus 0.00 events/30 days (P鈥�=鈥�0.063). Conclusions: URLi demonstrated good glycemic control that was comparable to lispro and showed a similar safety profile to lispro with the 670G hybrid closed-loop system. Trial registration: ClinicalTrials.gov, NCT03760640.

  • Link to Article
  • publication date
  • 2021
  • published in
    Research
    keywords
  • Diabetes
  • Drugs and Drug Therapy
  • Monitoring, Physiologic
  • Randomized Controlled Trials
  • Additional Document Info
    volume
  • 23
  • issue
  • 12