A Real-World Prospective Study of the Safety and Effectiveness of the Loop Open Source Automated Insulin Delivery System.
Diabetes Technol Ther
; 23(5): 367-375, 2021 05.
Article
em En
| MEDLINE
| ID: mdl-33226840
ABSTRACT
Objective:
To evaluate the safety and effectiveness of the Loop Do-It-Yourself automated insulin delivery system. Research Design andMethods:
A prospective real-world observational study was conducted, which included 558 adults and children (age range 1-71 years, mean HbA1c 6.8% ± 1.0%) who initiated Loop either on their own or with community-developed resources and provided data for 6 months.Results:
Mean time-in-range 70-180 mg/dL (TIR) increased from 67% ± 16% at baseline (before starting Loop) to 73% ± 13% during the 6 months (mean change from baseline 6.6%, 95% confidence interval [CI] 5.9%-7.4%; P < 0.001). TIR increased in both adults and children, across the full range of baseline HbA1c, and in participants with both high- and moderate-income levels. Median time <54 mg/dL was 0.40% at baseline and changed by -0.05% (95% CI -0.09% to -0.03%, P < 0.001). Mean HbA1c was 6.8% ± 1.0% at baseline and decreased to 6.5% ± 0.8% after 6 months (mean difference = -0.33%, 95% CI -0.40% to -0.26%, P < 0.001). The incidence rate of reported severe hypoglycemia events was 18.7 per 100 person-years, a reduction from the incidence rate of 181 per 100 person-years during the 3 months before the study. Among the 481 users providing Loop data at 6 months, median continuous glucose monitoring use was 96% (interquartile range [IQR] 91%-98%) and median time Loop modulating basal insulin was at least 83% (IQR 73%-88%).Conclusions:
The Loop open source system can be initiated with community-developed resources and used safely and effectively by adults and children with type 1 diabetes.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Diabetes Mellitus Tipo 1
/
Insulina
Tipo de estudo:
Observational_studies
/
Risk_factors_studies
Limite:
Adult
/
Child
/
Child, preschool
/
Humans
/
Infant
Idioma:
En
Revista:
Diabetes Technol Ther
Assunto da revista:
ENDOCRINOLOGIA
/
TERAPEUTICA
Ano de publicação:
2021
Tipo de documento:
Article
País de afiliação:
Estados Unidos