Continuos Subcutaneous Insulin Infusion in Italy

Type 1 Diabetes Clinical Trial

— IMITA2  

Official title:

Survey on Continuos Subcutaneous Insulin Infusion in Italy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02620917
• Other study ID #: 3506/AO/15
• Status: Completed
• Start date: November 1, 2015
• Est. completion date: December 1, 2017

Study information

• Verified date: March 2020
• Source: University of Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6623
• Est. completion date: December 1, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• all patients treated with CSIIin Italy

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Locations

Country	Name	City	State
Italy	University of Padova	Padova

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy Assessed by Median of HbA1c,	median of HbA1c measured in the last year	1 year
Primary	Patients With Severe Hypoglycemia	Number of patients reporting severe hypoglycemia (requiring assistance by an other person) in the last year	1year
Primary	Number of Patients With Glycated Hemoglobin on Target	number of patients who achieved HbA1c target (< 7,5% in patients < 18 years old; <7% in adult patients);	1 year
Secondary	Number of Patients With HbA1c on Target Using Advanced Pump's Functions, CGM and CHO Counting	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	1 year