Continuos Subcutaneous Insulin Infusion in Italy

Completed

• Conditions: Type 1 Diabetes

• Registration Number: NCT02620917
• Lead Sponsor: University of Padova

Brief Summary

This is an observational, multicenter, cross sectional study, collecting clinical and metabolic informations about patients treated with CSII in Italy.

Detailed Description

The aim of the study is to collect clinical and metabolic characteristics of patient treated with CSII in Italy.

Data will be collected through a questionnaire sent by e-mail to CSII experienced Diabetes Centers ( both adult and pediatric patients) . The questionnaire assessed: (1) number of CSII-treated patients; (2) patients and pump characteristics; (3) structure and organization of Diabetes Centers providing CSII therapy; (4) metabolic control.

Study Timeline

• Study Start: 2015-11-01
• Study First Submitted: 2015-11-23
• Study First Submitted QC: 2015-11-30
• Study First Posted: 2015-12-03
• Primary Completion: 2017-12-01
• Study Completion: 2017-12-01
• Results First Submitted: 2018-01-12
• Status Verified: 2020-03
• Results First Submitted QC: 2020-03-26
• Last Update Submitted: 2020-03-26
• Results First Posted: 2020-04-08
• Last Update Posted: 2020-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6623

Inclusion Criteria

• all patients treated with CSIIin Italy

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Patients With Glycated Hemoglobin on Target	1 year	number of patients who achieved HbA1c target (\< 7,5% in patients \< 18 years old; \<7% in adult patients);
Efficacy Assessed by Median of HbA1c,	1 year	median of HbA1c measured in the last year
Patients With Severe Hypoglycemia	1year	Number of patients reporting severe hypoglycemia (requiring assistance by an other person) in the last year

Secondary Outcome Measures

Name	Time	Method
Number of Patients With HbA1c on Target Using Advanced Pump's Functions, CGM and CHO Counting	1 year	number of patients adults with HbA1c \<7,0% using advanced pump's functions, CGM and CHO counting number of paediatrics patients with HbA1c \< 7.5% using advanced pump's functions, CGM and CHO counting

Trial Locations

Locations (1)

University of Padova; 🇮🇹 Padova, Italy