NCT04761094

Clinical Efficacy of Insulin Pumps in Type 1 Diabetes Mellitus Patients in Spain

Clinical Efficacy of Continuous Subcutaneous Insulin Infusion in Type 1 Diabetes Mellitus Patients in Spain

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,977 (actual)
• Sponsor: Castilla-La Mancha Health Service · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Observational cross-sectional multicenter study about clinical efficacy of insulin pumps in type 1 diabetes mellitus patients.

Detailed description

Observational cross-sectional multicenter study about clinical efficacy of continuous subcutaneous insulin infusion in type 1 diabetes mellitus patients. All clinical variables are gathered from the Spanish Insulin Pump National Registry. Data analysis is conducted using SPSS (Chicago, IL) statistic software. Results are presented as mean +/- SD values. 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
DEVICE	Insulin pump	Treatment with continuous subcutaneous insulin infusion

Timeline

• Start date: 2021-09-01
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2021-02-18
• Last updated: 2022-02-09

Locations

25 sites across 1 country: Spain

Regulatory

• FDA-regulated device study