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

NCT ID: NCT03338439

Last Updated: 2017-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

215 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-01

Study Completion Date

2017-10-31

Brief Summary

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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

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Conditions

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Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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CSII

CSII: patients with continuous subcutaneous insulin infusion

CSII

Intervention Type DEVICE

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

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pavia

OTHER

Sponsor Role lead

Responsible Party

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Giuseppe Derosa

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IRCCS Policlinico San Matteo Foundation

Pavia, PV, Italy

Site Status

Countries

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Italy

Other Identifiers

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20170003557

Identifier Type: -

Identifier Source: org_study_id