Overview

This trial is active, not recruiting.

Condition type 1 diabetes
Sponsor University of Padova
Start date November 2015
End date September 2016
Trial size 10000 participants
Trial identifier NCT02620917, 3506/AO/15

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective cross-sectional

Primary Outcomes

Measure
efficacy assessed by mean of HbA1c,
time frame: 1 year
safety assessed by number of severe hypoglycemia (requiring assistance by an other person) in the last year
time frame: 1year
efficacy assessed by number of patients with glycated hemoglobin value < 7,5%
time frame: 1 yesr

Secondary Outcomes

Measure
number of patients with HbA1c <7,5% using advanced pump's functions, CGM and CHO counting
time frame: 1 year

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - all patients treated with CSIIin Italy Exclusion Criteria:

Additional Information

Official title Survey on Continuos Subcutaneous Insulin Infusion in Italy
Principal investigator Daniela Bruttomesso, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University of Padova.