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This is an observational, multicenter, cross sectional study, collecting clinical and metabolic informations about patients treated with CSII in Italy.
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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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With HbA1c on Target Using Advanced Pump's Functions, CGM and CHO Counting | 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 | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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we will evaluate allItalian patients treated with insulin pump
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| Name | Affiliation | Role |
|---|---|---|
| Daniela Bruttomesso, MD, PhD | University of Padova | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Padova | Padova | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29428572 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Continuous Subcutaneous Insulin Infusion (CSII) Treatment | Patients who received Continuous subcutaneous insulin infusion (CSII) treatment in Italy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CSII Treatment | Patients who received CSII treatment in Italy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Efficacy Assessed by Median of HbA1c, | median of HbA1c measured in the last year | Posted | Median | Inter-Quartile Range | mmol/mol | 1 year |
|
|
time of observations= 1 years.
no adverse events (study correlated and not study correlated) occurred
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CSII Treatment | Patients who received CSII treatment in Italy | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniela Bruttomesso | University of Padova | 0039 049/8212183 | daniela.bruttomesso@unipd.it |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 30, 2015 | Mar 26, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Patients With Severe Hypoglycemia | Number of patients reporting severe hypoglycemia (requiring assistance by an other person) in the last year | Posted | Number | participants | 1year |
|
|
|
| Primary | 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); | Posted | Number | participants | 1 year |
|
|
|
| Secondary | Number of Patients With HbA1c on Target Using Advanced Pump's Functions, CGM and CHO Counting | 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 | Posted | Number | participants | 1 year |
|
|
|
| 6,223 |
| 0 |
| 6,223 |
| 0 |
| 6,223 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |