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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: CSII

• Study Type: Observational
• Enrollment (Actual): 215

Contacts and Locations

Study Locations

• Italy
  • PV
    • Pavia, PV, Italy, 27100
      • IRCCS Policlinico San Matteo Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with type 1 and type 2 diabetes mellitus taking insulin

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	Haemodynamic parameter	Change from Baseline, at 4 years and at 8 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular event	Atrial fibrillation	Change from Baseline, at 4 years and at 8 years
Cardiovascular event	Premature Ventricular Contractions	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

Collaborators and Investigators

• Sponsor: University of Pavia

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): October 31, 2017
• Study Completion (Actual): October 31, 2017

Study Registration Dates

• First Submitted: November 2, 2017
• First Submitted That Met QC Criteria: November 6, 2017
• First Posted (Actual): November 9, 2017

Study Record Updates

• Last Update Posted (Actual): November 9, 2017
• Last Update Submitted That Met QC Criteria: November 6, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 20170003557

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No