Aim: To evaluate hybrid closed-loop with ultra-rapid insulin lispro (Lyumjev) in adults with type 1 diabetes (T1D).
Methods: In a double-blind, randomized, crossover study, 28 adults with T1D (mean±SD; age 44.5±10.7 years, HbA1c 7.1±0.9% [54±10mmol/mol]) underwent two 8-week periods comparing hybrid closed-loop with Lyumjev and hybrid closed-loop with standard insulin lispro in random order. CamAPS FX closed-loop system was used in both periods.
Results: In an intention-to-treat analysis, proportion of time sensor glucose was in target range (70 to 180mg/dL; primary endpoint) was greater with Lyumjev compared with standard insulin lispro (mean±SD; 78.7±9.8% vs. 76.2±9.6%; mean difference 2.5 percentage points [95%CI 0.8 to 4.2]; p=0.005). Mean sensor glucose was lower with Lyumjev compared with standard insulin lispro (142±14mg/dL vs. 146±16mg/dL; p=0.048). Proportion of time with sensor glucose <70mg/dL was similar between interventions (median[IQR] Lyumjev 2.3% [1.3-2.7%] vs. standard insulin lispro 2.1% [1.4-3.3%]; p=0.33). No severe hypoglycemia or ketoacidosis occurred.
Conclusions: The use of Lyumjev with CamAPS FX hybrid closed-loop increases time in range and reduces mean glucose with no difference in hypoglycemia compared with standard insulin lispro in adults with T1D.
M.Nwokolo: None. R.Lakshman: None. C.K.Boughton: Consultant; CamDiab Ltd., Speaker's Bureau; Ypsomed AG. J.Ware: Other Relationship; Ypsomed AG. J.M.Allen: Research Support; CamDiab Ltd. M.E.Wilinska: Consultant; CamDiab Ltd. H.Alwan: None. M.Evans: Advisory Panel; Zucara Therapeutics, Pila Pharma, Dexcom, Inc., Other Relationship; Novo Nordisk, AstraZeneca, Abbott Diabetes, Speaker's Bureau; Eli Lilly and Company. R.Hovorka: Advisory Panel; Ypsomed AG, Consultant; Abbott Diabetes, B.Braun, Speaker's Bureau; Eli Lilly and Company, Stock/Shareholder; CamDiab Ltd.
National Institute for Health and Care Research; Cambridge Biomedical Research Centre (BRC-1215-20014)
