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Completed

NCT Number: NCT03338439

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

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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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Policlinico San Matteo Foundation

Pavia, PV, 27100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Pavia

Other

Registry information

Official study title

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

Acronym: ITALICO

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Nov 9, 2017
Registry last updated
Nov 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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