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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date November 2, 2017
First Posted Date November 9, 2017
Last Update Posted Date November 9, 2017
Actual Study Start Date July 1, 2017
Actual Primary Completion Date October 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 6, 2017)
  • Fasting glycemia [ Time Frame: Change from Baseline, at 4 years and at 8 years ]
    Carbohydrate metabolism
  • Postprandial glycemia [ Time Frame: Change from Baseline, at 4 years and at 8 years ]
    Carbohydrate metabolism
  • Glycated haemoglobin [ Time Frame: Change from Baseline, at 4 years and at 8 years ]
    Index of glycemic compensation
  • Total Cholesterol [ Time Frame: Change from Baseline, at 4 years and at 8 years ]
    Lipid metabolism
  • HDL-Cholesterol [ Time Frame: Change from Baseline, at 4 years and at 8 years ]
    Lipid metabolism
  • Triglycerides [ Time Frame: Change from Baseline, at 4 years and at 8 years ]
    Lipid metabolism
  • LDL-Cholesterol [ Time Frame: Change from Baseline, at 4 years and at 8 years ]
    Lipid metabolism
  • Systolic Blood Pressure [ Time Frame: Change from Baseline, at 4 years and at 8 years ]
    Haemodynamic parameter
  • Diastolic Blood Pressure [ Time Frame: Change from Baseline, at 4 years and at 8 years ]
    Haemodynamic parameter
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: November 6, 2017)
  • Cardiovascular event [ Time Frame: Change from Baseline, at 4 years and at 8 years ]
    Atrial fibrillation
  • Cardiovascular event [ Time Frame: Change from Baseline, at 4 years and at 8 years ]
    Premature Ventricular Contractions
  • Cardiovascular event [ Time Frame: Change from Baseline, at 4 years and at 8 years ]
    Acute Coronary Infarction
  • Cardiovascular event [ Time Frame: Change from Baseline, at 4 years and at 8 years ]
    Angina Pectoris
  • Cardiovascular event [ Time Frame: Change from Baseline, at 4 years and at 8 years ]
    Pericarditis
  • Cerebrovascular event [ Time Frame: Change from Baseline, at 4 years and at 8 years ]
    Ischemic Stroke
  • Vascular event [ Time Frame: Change from Baseline, at 4 years and at 8 years ]
    Peripheral Vascular Ischemia
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Insulin Pump vs Multiple Daily Injection on Cardiovascular Outcomes (ITALICO)
Official Title Glyco-metabolic Control, Inflammation Markers and Cardiovascular Outcomes in Diabetic Patients on Insulin Pump or Multiple Daily Injection
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with type 1 and type 2 diabetes mellitus taking insulin
Condition Diabetes Mellitus
Intervention 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.
Study Groups/Cohorts
  • CSII
    CSII: patients with continuous subcutaneous insulin infusion
    Intervention: Device: CSII
  • MDI
    MDI: patients with multi-daily injections
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 6, 2017)
215
Original Actual Enrollment Same as current
Actual Study Completion Date October 31, 2017
Actual Primary Completion Date October 31, 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT03338439
Other Study ID Numbers 20170003557
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Giuseppe Derosa, University of Pavia
Study Sponsor University of Pavia
Collaborators Not Provided
Investigators Not Provided
PRS Account University of Pavia
Verification Date November 2017