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 Technol Ther
; 25(12): 856-863, 2023 Dec.
Article
en En
| MEDLINE
| ID: mdl-37823892
ABSTRACT
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 andMethods:
In a single-center, double-blind, randomized, crossover study, 28 adults with type 1 diabetes (mean ± standard deviation [SD] age 44.5 ± 10.7 years, glycated hemoglobin (HbA1c) 7.1 ± 0.9% [54 ± 10 mmol/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. The same CamAPS FX closed-loop algorithm was used in both periods.Results:
In an intention-to-treat analysis, the proportion of time sensor glucose was in target range (3.9-10 mmol/L [70-180 mg/dL]; 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% confidence interval 0.8 to 4.2]; P = 0.005). Mean sensor glucose was lower with ultra-rapid lispro compared with standard insulin lispro (7.9 ± 0.8 mmol/L [142 ± 14 mg/dL] vs. 8.1 ± 0.9 mmol/L [146 ± 16 mg/dL]; P = 0.048). The proportion of time with sensor glucose <3.9 mmol/L [70 mg/dL] was similar between interventions (median [interquartile range] 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. ClinicalTrials.gov Trial registration number NCT05257460.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Diabetes Mellitus Tipo 1
/
Hipoglucemia
Tipo de estudio:
Clinical_trials
Límite:
Adult
/
Humans
/
Middle aged
Idioma:
En
Revista:
Diabetes Technol Ther
Asunto de la revista:
ENDOCRINOLOGIA
/
TERAPEUTICA
Año:
2023
Tipo del documento:
Article
País de afiliación:
Reino Unido