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

J

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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