A 4-Week, Two-Center, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of EOPatch in Well-Controlled Type 1 Diabetes Mellitus.
Diabetes Metab J
; 46(6): 941-947, 2022 11.
Article
em En
| MEDLINE
| ID: mdl-35255546
ABSTRACT
This study evaluated the safety and efficacy of tubeless patch pump called EOPatch in patients with well-controlled type 1 diabetes mellitus (T1DM). This 4-week, two-center, open-label, single-arm study enrolled 10 adult patients diagnosed with T1DM with glycosylated hemoglobin less than 7.5%. The co-primary end points were patch pump usage time for one attachment and number of serious adverse events related to the patch pump. The secondary end points were total amount of insulin injected per patch and changes in glycemic parameters including continuous glucose monitoring data compared to those at study entry. The median usage time per patch was 84.00 hours (interquartile range, 64.50 to 92.50). Serious adverse events did not occur during the trial. Four weeks later, time in range 70 to 180 mg/dL was significantly improved (70.71%±17.14 % vs. 82.96%±9.14%, P=0.01). The times spent below range (<54 mg/dL) and above range (>180 mg/dL) also improved (All P<0.05). Four-week treatment with a tubeless patch pump was safe and led to clinical improvement in glycemic control.
Palavras-chave
Texto completo:
1
Bases de dados:
MEDLINE
Assunto principal:
Sistemas de Infusão de Insulina
/
Diabetes Mellitus Tipo 1
Limite:
Adult
/
Humans
Idioma:
En
Revista:
Diabetes Metab J
Ano de publicação:
2022
Tipo de documento:
Article