Insulin Pump vs Multiple Daily Injection on Cardiovascular Outcomes (ITALICO)

Study Overview
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Brief Summary
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The aim of this study was to evaluate if the positive effects recorded on glycemic control with CSII were maintained on the long term compared to multi-daily injections (MDI). The secondary objective was to evaluate if there is a reduction of type and number of cardiovascular events (CV) in CSII group compared to MDI group after 8 years of observation. This retrospective, observational trial evaluated 104 diabetic patients with prior treatment with MDI initiating CSII therapy compared to 109 diabetic patients continuing MDI.

Official Title
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Glyco-metabolic Control, Inflammation Markers and Cardiovascular Outcomes in Diabetic Patients on Insulin Pump or Multiple Daily Injection

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: CSII


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with type 1 or 2 diabetes with prior treatment with MDI initiating CSII therapy with tubed insulin pumps patients type 1 or 2 diabetes with prior treatment with MDI continuing MDI patients attending the center for at least 8 years Exclusion Criteria: patients not taking insulin

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CSII<br>CSII: patients with continuous subcutaneous insulin infusion | Device: CSII<br>* This retrospective, observational trial will evaluate 104 diabetic patients with prior treatment with MDI initiating CSII therapy compared to 109 diabetic patients continuing MDI.<br>|
| MDI<br>MDI: patients with multi-daily injections | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting glycemia | Carbohydrate metabolism | Change from Baseline, at 4 years and at 8 years | 
| Postprandial glycemia | Carbohydrate metabolism | Change from Baseline, at 4 years and at 8 years | 
| Glycated haemoglobin | Index of glycemic compensation | Change from Baseline, at 4 years and at 8 years | 
| Total Cholesterol | Lipid metabolism | Change from Baseline, at 4 years and at 8 years | 
| HDL-Cholesterol | Lipid metabolism | Change from Baseline, at 4 years and at 8 years | 
| Triglycerides | Lipid metabolism | Change from Baseline, at 4 years and at 8 years | 
| LDL-Cholesterol | Lipid metabolism | Change from Baseline, at 4 years and at 8 years | 
| Systolic Blood Pressure | Haemodynamic parameter | Change from Baseline, at 4 years and at 8 years | 
| Diastolic Blood Pressure | Haemodynamic parameter | Change from Baseline, at 4 years and at 8 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular event | Atrial fibrillation | Change from Baseline, at 4 years and at 8 years | 
| Cardiovascular event | Premature Ventricular Contractions | Change from Baseline, at 4 years and at 8 years | 
| Cardiovascular event | Acute Coronary Infarction | Change from Baseline, at 4 years and at 8 years | 
| Cardiovascular event | Angina Pectoris | Change from Baseline, at 4 years and at 8 years | 
| Cardiovascular event | Pericarditis | Change from Baseline, at 4 years and at 8 years | 
| Cerebrovascular event | Ischemic Stroke | Change from Baseline, at 4 years and at 8 years | 
| Vascular event | Peripheral Vascular Ischemia | Change from Baseline, at 4 years and at 8 years |