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

Diabetes Mellitus Clinical Trial

— ITALICO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03338439
• Other study ID #: 20170003557
• Status: Completed
• Phase: N/A
• First received: November 2, 2017
• Last updated: November 6, 2017
• Start date: July 1, 2017
• Est. completion date: October 31, 2017

Study information

• Verified date: November 2017
• Source: University of Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: October 31, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• 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.

Locations

Country	Name	City	State
Italy	IRCCS Policlinico San Matteo Foundation	Pavia	PV

Sponsors (1)

Lead Sponsor	Collaborator
University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting glycemia	Carbohydrate metabolism	Change from Baseline, at 4 years and at 8 years
Primary	Postprandial glycemia	Carbohydrate metabolism	Change from Baseline, at 4 years and at 8 years
Primary	Glycated haemoglobin	Index of glycemic compensation	Change from Baseline, at 4 years and at 8 years
Primary	Total Cholesterol	Lipid metabolism	Change from Baseline, at 4 years and at 8 years
Primary	HDL-Cholesterol	Lipid metabolism	Change from Baseline, at 4 years and at 8 years
Primary	Triglycerides	Lipid metabolism	Change from Baseline, at 4 years and at 8 years
Primary	LDL-Cholesterol	Lipid metabolism	Change from Baseline, at 4 years and at 8 years
Primary	Systolic Blood Pressure	Haemodynamic parameter	Change from Baseline, at 4 years and at 8 years
Primary	Diastolic Blood Pressure	Haemodynamic parameter	Change from Baseline, at 4 years and at 8 years
Secondary	Cardiovascular event	Atrial fibrillation	Change from Baseline, at 4 years and at 8 years
Secondary	Cardiovascular event	Premature Ventricular Contractions	Change from Baseline, at 4 years and at 8 years
Secondary	Cardiovascular event	Acute Coronary Infarction	Change from Baseline, at 4 years and at 8 years
Secondary	Cardiovascular event	Angina Pectoris	Change from Baseline, at 4 years and at 8 years
Secondary	Cardiovascular event	Pericarditis	Change from Baseline, at 4 years and at 8 years
Secondary	Cerebrovascular event	Ischemic Stroke	Change from Baseline, at 4 years and at 8 years
Secondary	Vascular event	Peripheral Vascular Ischemia	Change from Baseline, at 4 years and at 8 years