CamAPS FX hybrid closed-loop with ultra-rapid lispro compared with standard lispro in adults with type 1 diabetes: a double-blind, randomized, crossover study.

Nwokolo, Munachiso; Lakshman, Rama; Hartnell, Sara; Alwan, Heba; Ware, Julia; Allen, Janet M; Wilinska, Malgorzata; Evans, Mark; Hovorka, Roman; Boughton, Charlotte K (2023). CamAPS FX hybrid closed-loop with ultra-rapid lispro compared with standard lispro in adults with type 1 diabetes: a double-blind, randomized, crossover study. Diabetes technology & therapeutics, 25(12), pp. 856-863. Mary Ann Liebert 10.1089/dia.2023.0262

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INTRODUCTION

To evaluate hybrid closed-loop with ultra-rapid insulin lispro (Lyumjev) compared with hybrid closed-loop with standard insulin lispro in adults with type 1 diabetes.

MATERIALS AND METHODS

In a single-center, double-blind, randomized, crossover study, 28 adults with type 1 diabetes (mean±SD: age 44.5±10.7, HbA1c 7.1±0.9% [54±10mmol/mol]) underwent two 8-week periods comparing hybrid closed-loop with ultra-rapid insulin lispro 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, the proportion of time sensor glucose was in target range (3.9 to 10mmol/L; primary endpoint) was greater with ultra-rapid lispro 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 ultra-rapid lispro compared with standard insulin lispro (7.9±0.8mmol/L vs. 8.1±0.9mmol/L; p=0.048). The proportion of time with sensor glucose <3.9mmol/L was similar between interventions (median [IQR] ultra-rapid lispro 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 ultra-rapid lispro 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 type 1 diabetes.

Interest & Impact

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