Continuos Subcutaneous Insulin Infusion in Italy
IMITA2
Survey on Continuos Subcutaneous Insulin Infusion in Italy
1 other identifier
observational
6,623
1 country
1
Brief Summary
This is an observational, multicenter, cross sectional study, collecting clinical and metabolic informations about patients treated with CSII in Italy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 23, 2015
CompletedFirst Posted
Study publicly available on registry
December 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedResults Posted
Study results publicly available
April 8, 2020
CompletedApril 8, 2020
March 1, 2020
2.1 years
November 23, 2015
January 12, 2018
March 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Efficacy Assessed by Median of HbA1c,
median of HbA1c measured in the last year
1 year
Patients With Severe Hypoglycemia
Number of patients reporting severe hypoglycemia (requiring assistance by an other person) in the last year
1year
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 Outcomes (1)
Number of Patients With HbA1c on Target Using Advanced Pump's Functions, CGM and CHO Counting
1 year
Eligibility Criteria
we will evaluate allItalian patients treated with insulin pump
You may qualify if:
- all patients treated with CSIIin Italy
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Padova
Padua, Italy
Related Publications (1)
Lepore G, Bonfanti R, Bozzetto L, Di Blasi V, Girelli A, Grassi G, Iafusco D, Laviola L, Rabbone I, Schiaffini R, Bruttomesso D; Italian Study Group on the Diffusion of CSII. Metabolic control and complications in Italian people with diabetes treated with continuous subcutaneous insulin infusion. Nutr Metab Cardiovasc Dis. 2018 Apr;28(4):335-342. doi: 10.1016/j.numecd.2017.12.001. Epub 2017 Dec 9.
PMID: 29428572DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Daniela Bruttomesso
- Organization
- University of Padova
Study Officials
- PRINCIPAL INVESTIGATOR
Daniela Bruttomesso, MD, PhD
University of Padova
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD medical doctor, PhD
Study Record Dates
First Submitted
November 23, 2015
First Posted
December 3, 2015
Study Start
November 1, 2015
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
April 8, 2020
Results First Posted
April 8, 2020
Record last verified: 2020-03