NCT04233203

Faster Aspart on Insulin-pump Treated T1DM Patients

Effectiveness and Safety of Insulin Faster Aspart on Continuous Subcutaneous Insulin Infusion Treated Adult Type 1 Diabetes Mellitus Patients in Routine Clinical Practice

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 48 (actual)
• Sponsor: Jesús Moreno Fernández · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DRUG	Insulin Faster Aspart	Currently receiving Faster Aspart during 3 or more months.
DEVICE	Insulin pump	Currently receiving CSII therapy during 6 or more months.

Timeline

• Start date: 2020-01-31
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2020-01-18
• Last updated: 2021-02-01

Locations

1 site across 1 country: Spain

Regulatory

• FDA-regulated drug study
• FDA-regulated device study