Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 11:57 PM
Study NCT ID:
NCT04761094
Status:
COMPLETED
Last Update Posted:
2022-02-09
First Post:
2021-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Efficacy of Insulin Pumps in Type 1 Diabetes Mellitus Patients in Spain
Sponsor:
Castilla-La Mancha Health Service
Organization:
Study Overview
Official Title:
Clinical Efficacy of Continuous Subcutaneous Insulin Infusion in Type 1 Diabetes Mellitus Patients in Spain
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: