Clinical trial NCT03338439: Insulin Pump vs Multiple Daily Injection on Cardiovascular Outcomes (ITALICO)
Official title: Glyco-metabolic Control, Inflammation Markers and Cardiovascular Outcomes in Diabetic Patients on Insulin Pump or Multiple Daily Injection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2017-11-09
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with type 1 and type 2 diabetes mellitus taking insulin

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.


Eligibility criteria: 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

Primary outcomes:
measure: Fasting glycemia
timeFrame: Change from Baseline, at 4 years and at 8 years
measure: Postprandial glycemia
timeFrame: Change from Baseline, at 4 years and at 8 years
measure: Glycated haemoglobin
timeFrame: Change from Baseline, at 4 years and at 8 years
measure: Total Cholesterol
timeFrame: Change from Baseline, at 4 years and at 8 years
measure: HDL-Cholesterol
timeFrame: Change from Baseline, at 4 years and at 8 years
measure: Triglycerides
timeFrame: Change from Baseline, at 4 years and at 8 years
measure: LDL-Cholesterol
timeFrame: Change from Baseline, at 4 years and at 8 years
measure: Systolic Blood Pressure
timeFrame: Change from Baseline, at 4 years and at 8 years
measure: Diastolic Blood Pressure
timeFrame: Change from Baseline, at 4 years and at 8 years
Secondary outcomes:
measure: Cardiovascular event
timeFrame: Change from Baseline, at 4 years and at 8 years
measure: Cardiovascular event
timeFrame: Change from Baseline, at 4 years and at 8 years
measure: Cardiovascular event
timeFrame: Change from Baseline, at 4 years and at 8 years
measure: Cardiovascular event
timeFrame: Change from Baseline, at 4 years and at 8 years
measure: Cardiovascular event
timeFrame: Change from Baseline, at 4 years and at 8 years
measure: Cerebrovascular event
timeFrame: Change from Baseline, at 4 years and at 8 years
measure: Vascular event
timeFrame: Change from Baseline, at 4 years and at 8 years
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo Foundation
state: PV
Study officials:
References: