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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03338439

Acronym

ITALICO

Enrollment

215

Registered

2017-11-09

Start date

2017-07-01

Completion date

2017-10-31

Last updated

2017-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

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.

Interventions

DEVICECSII

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 design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Cerebrovascular event	Change from Baseline, at 4 years and at 8 years	Ischemic Stroke
Vascular event	Change from Baseline, at 4 years and at 8 years	Peripheral Vascular Ischemia
Cardiovascular event	Change from Baseline, at 4 years and at 8 years	Atrial fibrillation

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026