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

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ClinicalTrials.gov Identifier: NCT03338439
Recruitment Status : Completed
First Posted : November 9, 2017
Last Update Posted : November 9, 2017
Sponsor:
Information provided by (Responsible Party):
Giuseppe Derosa, University of Pavia

Brief Summary:
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.

Condition or disease Intervention/treatment
Diabetes Mellitus Device: CSII

Study Type : Observational
Actual Enrollment : 215 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Glyco-metabolic Control, Inflammation Markers and Cardiovascular Outcomes in Diabetic Patients on Insulin Pump or Multiple Daily Injection
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : October 31, 2017
Actual Study Completion Date : October 31, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

Group/Cohort Intervention/treatment
CSII
CSII: patients with continuous subcutaneous insulin infusion
Device: CSII
This retrospective, observational trial will evaluate 104 diabetic patients with prior treatment with MDI initiating CSII therapy compared to 109 diabetic patients continuing MDI.

MDI
MDI: patients with multi-daily injections



Primary Outcome Measures :
  1. Fasting glycemia [ Time Frame: Change from Baseline, at 4 years and at 8 years ]
    Carbohydrate metabolism

  2. Postprandial glycemia [ Time Frame: Change from Baseline, at 4 years and at 8 years ]
    Carbohydrate metabolism

  3. Glycated haemoglobin [ Time Frame: Change from Baseline, at 4 years and at 8 years ]
    Index of glycemic compensation

  4. Total Cholesterol [ Time Frame: Change from Baseline, at 4 years and at 8 years ]
    Lipid metabolism

  5. HDL-Cholesterol [ Time Frame: Change from Baseline, at 4 years and at 8 years ]
    Lipid metabolism

  6. Triglycerides [ Time Frame: Change from Baseline, at 4 years and at 8 years ]
    Lipid metabolism

  7. LDL-Cholesterol [ Time Frame: Change from Baseline, at 4 years and at 8 years ]
    Lipid metabolism

  8. Systolic Blood Pressure [ Time Frame: Change from Baseline, at 4 years and at 8 years ]
    Haemodynamic parameter

  9. Diastolic Blood Pressure [ Time Frame: Change from Baseline, at 4 years and at 8 years ]
    Haemodynamic parameter


Secondary Outcome Measures :
  1. Cardiovascular event [ Time Frame: Change from Baseline, at 4 years and at 8 years ]
    Atrial fibrillation

  2. Cardiovascular event [ Time Frame: Change from Baseline, at 4 years and at 8 years ]
    Premature Ventricular Contractions

  3. Cardiovascular event [ Time Frame: Change from Baseline, at 4 years and at 8 years ]
    Acute Coronary Infarction

  4. Cardiovascular event [ Time Frame: Change from Baseline, at 4 years and at 8 years ]
    Angina Pectoris

  5. Cardiovascular event [ Time Frame: Change from Baseline, at 4 years and at 8 years ]
    Pericarditis

  6. Cerebrovascular event [ Time Frame: Change from Baseline, at 4 years and at 8 years ]
    Ischemic Stroke

  7. Vascular event [ Time Frame: Change from Baseline, at 4 years and at 8 years ]
    Peripheral Vascular Ischemia



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with type 1 and type 2 diabetes mellitus taking insulin
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338439


Locations
Italy
IRCCS Policlinico San Matteo Foundation
Pavia, PV, Italy, 27100
Sponsors and Collaborators
University of Pavia

Responsible Party: Giuseppe Derosa, Clinical Professor, University of Pavia
ClinicalTrials.gov Identifier: NCT03338439     History of Changes
Other Study ID Numbers: 20170003557
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs