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Completed

NCT Number: NCT02620917

Continuos Subcutaneous Insulin Infusion in Italy

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

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Padova

Padova, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all patients treated with CSIIin Italy

Exclusion criteria

  • none

Treatment and study plan

Primary outcomes

  1. Efficacy Assessed by Median of HbA1c,

    Time frame: 1 year

    median of HbA1c measured in the last year

  2. Patients With Severe Hypoglycemia

    Time frame: 1year

    Number of patients reporting severe hypoglycemia (requiring assistance by an other person) in the last year

  3. Number of Patients With Glycated Hemoglobin on Target

    Time frame: 1 year

    number of patients who achieved HbA1c target (< 7,5% in patients < 18 years old; <7% in adult patients);

Secondary outcomes

  1. Number of Patients With HbA1c on Target Using Advanced Pump's Functions, CGM and CHO Counting

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Registry information

Official study title

Survey on Continuos Subcutaneous Insulin Infusion in Italy

Acronym: IMITA2

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 3, 2015
Registry last updated
Apr 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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