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

Completed

• Conditions: Diabetes Mellitus
• Interventions: Device: CSII

• Registration Number: NCT03338439
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-01
• Primary Completion: 2017-10-31
• Study Completion: 2017-10-31
• Status Verified: 2017-11
• Study First Submitted: 2017-11-02
• Study First Submitted QC: 2017-11-06
• Last Update Submitted: 2017-11-06
• Study First Posted: 2017-11-09
• Last Update Posted: 2017-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 215

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CSII	CSII	CSII: patients with continuous subcutaneous insulin infusion

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	Pericarditis

Trial Locations

Locations (1)

IRCCS Policlinico San Matteo Foundation; 🇮🇹 Pavia, PV, Italy