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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CSII | CSII: patients with continuous subcutaneous insulin infusion |
| |
| MDI | MDI: patients with multi-daily injections |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CSII | Device | This retrospective, observational trial will evaluate 104 diabetic patients with prior treatment with MDI initiating CSII therapy compared to 109 diabetic patients continuing MDI. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular event | Atrial fibrillation | Change from Baseline, at 4 years and at 8 years |
| Cardiovascular event | Premature Ventricular Contractions |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with type 1 and type 2 diabetes mellitus taking insulin
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Policlinico San Matteo Foundation | Pavia | PV | 27100 | Italy |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Haemodynamic parameter |
| Change from Baseline, at 4 years and at 8 years |
| 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 |