Faster Aspart on Insulin-pump Treated T1DM Patients (realFACI)

Jesús Moreno Fernández

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Drug: Insulin Faster Aspart; Device: Insulin pump

Study type: Observational

Funder types: Other

Identifiers

NCT04233203

C-302

Details and patient eligibility

About

Observational retrospective study about effectiveness and safety of insulin Faster Aspart on continuous subcutaneous insulin infusion treated adult Type 1 Diabetes Mellitus (T1DM) patients in routine clinical practice.

Full description

Cross-sectional retrospective analysis about effectiveness and safety of insulin Faster Aspart on continuous subcutaneous insulin infusion treated adult Type 1 Diabetes Mellitus (T1DM) patients in routine clinical practice.

All clinical variables are gathered from two EMR softwares (Mambrino XXI and Carelink Pro®).

Data analysis is conducted using SPSS (Chicago, IL) statistics software. Results are presented as mean ± SD values or percentages. A paired Student's t-test or a Wilcoxon signed-rank test were used for the analysis of differences. Comparisons between proportions were analyzed using a chi-squared test. A P value < 0.05 was considered statistically significant.

The protocol was approved by the reference Castilla-La Mancha Public Health Institute Ethic Committee. All participants provided written informed consent.

Enrollment: 48 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥18 years of age.
• Diagnosed of Type 1 Diabetes Mellitus.
• Be attended in Ciudad Real General University Hospital.
• Current treated with CSII (CSII cohort) during ≥6 months.
• Current treated with insulin Faster Aspart during ≥3 months.

Exclusion criteria

• Less than 18 years old.
• Other types of diabetes mellitus.

Trial design

48 participants in 1 patient group

Faster Aspart

Description:

All T1DM adult patients attended in Ciudad Real General University Hospital and treated with CSII and insulin Faster Aspart.

Treatment:

Device: Insulin pump

Drug: Insulin Faster Aspart