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Trial record 61 of 447 for:    subcutaneous | "Diabetes Mellitus, Insulin-Dependent"

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
Sponsor:
Information provided by (Responsible Party):
Daniela Bruttomesso, 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.

Condition or disease
Type 1 Diabetes

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.


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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1




Primary Outcome Measures :
  1. efficacy assessed by mean of HbA1c, [ Time Frame: 1 year ]
    mean of HbA1c measured in the last year

  2. 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

  3. 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%


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
we will evaluate allItalian patients treated with insulin pump
Criteria

Inclusion Criteria:

  • all patients treated with CSIIin Italy

Exclusion Criteria:

  • none

Information from the National Library of Medicine

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


Locations
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Italy
University of Padova
Padova, Italy
Sponsors and Collaborators
University of Padova
Investigators
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Principal Investigator: Daniela Bruttomesso, MD, PhD University of Padova

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Daniela Bruttomesso, MD medical doctor, PhD, University of Padova
ClinicalTrials.gov Identifier: NCT02620917     History of Changes
Other Study ID Numbers: 3506/AO/15
First Posted: December 3, 2015    Key Record Dates
Last Update Posted: October 4, 2017
Last Verified: April 2017

Keywords provided by Daniela Bruttomesso, University of Padova:
type 1 diabetes
CSII

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases