Continuos Subcutaneous Insulin Infusion in Italy (IMITA2)
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|ClinicalTrials.gov Identifier: NCT02620917|
Recruitment Status : Unknown
Verified April 2017 by Daniela Bruttomesso, University of Padova.
Recruitment status was: Active, not recruiting
First Posted : December 3, 2015
Last Update Posted : October 4, 2017
|Condition or disease|
|Type 1 Diabetes|
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 Type :||Observational|
|Estimated Enrollment :||10000 participants|
|Official Title:||Survey on Continuos Subcutaneous Insulin Infusion in Italy|
|Actual Study Start Date :||November 2015|
|Estimated Primary Completion Date :||December 1, 2017|
|Estimated Study Completion Date :||December 1, 2017|
- efficacy assessed by mean of HbA1c, [ Time Frame: 1 year ]mean of HbA1c measured in the last year
- safety assessed by number of severe hypoglycemia (requiring assistance by an other person) in the last year [ Time Frame: 1year ]number of severe hypoglycemia (requiring assistance by an other person) in the last year
- efficacy assessed by number of patients with glycated hemoglobin value < 7,5% [ Time Frame: 1 yesr ]number of patients with glycated hemoglobin value < 7,5%
- number of patients with HbA1c <7,5% using advanced pump's functions, CGM and CHO counting [ Time Frame: 1 year ]number of patients with HbA1c <7,5% using advanced pump's functions, CGM and CHO counting
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02620917
|University of Padova|
|Principal Investigator:||Daniela Bruttomesso, MD, PhD||University of Padova|