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Heart & Diabetes - Feasibility Study

NCT00922402 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-07-03

No results posted yet for this study

Summary

The main purpose of this study is to validate an intensive protocol of insulin infusion and subsequent subcutaneous insulin administration with the support of continuous glucose monitoring, in addition to reference finger-stick values.

Conditions

  • Acute Heart Failure

Interventions

PROCEDURE

Intensive insulin infusion

The intensive control of glycemia is obtained with a shared in-hospital insulin infusion protocol, supported by the use of a continuous glucose monitoring system (Medtronic Guardian REAL Time). Any sudden variation of glycemia levels and/or alarms, as indicated by the device, has to be confirmed with a finger-stick before any therapy modification. In-hospital management is subdivided in a 2-day intensive and a 3-day post-intensive phase.

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • Riccardo Vigneri, MD · Garibaldi-Nesima Hospital - Catania - Italy

  • Maddalena Lettino, MD · Policlinico S. Matteo - Pavia - Italy

  • Michele Gulizia, MD · Garibaldi-Nesima Hospital - Catania - Italy

  • Luigi Magnani, MD · Policlinico S. Matteo - Pavia - Italy

  • Luigi Tavazzi, MD · Ospedale Villa Maria Cecilia - Gruppo Villa Maria - Cotignola (Ravenna) - Italy

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00922402 on ClinicalTrials.gov