Fast-Acting Insulin Aspart Versus Insulin Aspart Using a Second-Generation Hybrid Closed-Loop System in Adults With Type 1 Diabetes: A Randomized, Open-Label, Crossover Trial

Abstract

OBJECTIVE To evaluate glucose control using fast-acting insulin aspart (faster aspart) compared with insulin aspart (IAsp) delivered by the MiniMed Advanced Hybrid Closed-Loop (AHCL) system in adults with type 1 diabetes. RESEARCH DESIGN AND METHODS In this randomized, open-label, crossover study, participants were assigned to receive faster aspart or IAsp in random order. Stages 1 and 2 comprised of 6 weeks in closed loop, preceded by 2 weeks in open loop. This was followed by stage 3, whereby participants changed directly back to the insulin formulation used in stage 1 for 1 week in closed loop. Participants chose their own meals except for two standardized meal tests, a missed meal bolus and late meal bolus. The primary outcome was the percentage of time sensor glucose values were from 70 to 180 mg/dL (time in range [TIR]). RESULTS Twenty-five adults (52% male) were recruited; the median (interquartile range) age was 48 (37, 57) years, and the median HbA1c was 7.0% (6.6, 7.2) (53 [49, 55] mmol/mol). Faster aspart demonstrated greater overall TIR compared with IAsp (82.3% [78.5, 83.7] vs. 79.6% [77.0, 83.4], respectively; mean difference 1.9% [0.5, 3.3]; P = 0.007). Four-hour postprandial glucose TIR was higher using faster aspart compared with IAsp for all meals combined (73.6% [69.4, 80.2] vs. 72.1% [64.5, 78.5], respectively; median difference 3.5% [1.0, 7.3]; P = 0.003). There was no ketoacidosis or severe hypoglycemia. CONCLUSIONS Faster aspart safely improved glucose control compared with IAsp in a group of adults with well-controlled type 1 diabetes using AHCL. The modest improvement was mainly related to mealtime glycemia. While the primary outcome demonstrated statistical significance, the clinical impact may be small, given an overall difference in TIR of 1.9%.

Comparative assessment of modern parameters of glycemic control in children with type 1 diabetes after switching to fast-acting insulin aspart using Flash Glucose Monitoring in real clinical practice

“…Интересным является тот факт, что те же результаты, но статистически значимые, были получены и в рандомизированном клиническом исследовании с участием только пациентов на ППИИ с использованием наиболее современных инсулиновых помп с закрытым контуром [29].…”

Postprandial glucose‐management strategies in type 1 diabetes: Current approaches and prospects with precision medicine and artificial intelligence

“…The overall benefits of ultra‐rapid insulin analogues, Fiasp (Novo Nordisk, Denmark) and Lyumjev (Eli Lilly, USA), in hybrid closed‐loop systems have been minimal 93,94 ; one clinical study showed a small but significant reduction in 4‐hour postprandial hyperglycaemia, especially after a missed meal bolus 95 . Novel insulin analogues with more accelerated pharmacokinetics and pharmacodynamics are needed for significant clinical benefits, necessitating tailored insulin‐delivery strategies to match with faster insulin analogues.…”

Study protocol for a randomised open-label clinical trial examining the safety and efficacy of the Android Artificial Pancreas System (AAPS) with advanced bolus-free features in adults with type 1 diabetes: the ‘CLOSE IT’ (Closed Loop Open SourcE In Type 1 diabetes) trial

“…Compared with insulin aspart alone (NovoRapid), subcutaneous injection of Fiasp results in more rapid appearance of insulin in the intravascular space 23 24. Fiasp has shown modest improvements in TIR in trials of HCL systems,25 26 and in a pivotal trial of the iLet Bionic Pancreas which uses ‘simplified meal announcement’ 27. Improved TIR has also been demonstrated with the ultra-rapid-acting preparation Lyumjev in HCL users 28.…”

“…Improved TIR has also been demonstrated with the ultra-rapid-acting preparation Lyumjev in HCL users 28. However, Fiasp and NovoRapid have only been directly compared in AID users consuming unannounced meals in small short-term studies 26 29…”