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

U

University of Pavia

Status

Completed

Conditions

Diabetes Mellitus

Treatments

Device: CSII

Study type

Observational

Funder types

Other

Identifiers

NCT03338439
20170003557

Details and patient eligibility

About

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.

Enrollment

215 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

215 participants in 2 patient groups

CSII
Description:
CSII: patients with continuous subcutaneous insulin infusion
Treatment:
Device: CSII
MDI
Description:
MDI: patients with multi-daily injections

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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