Heart & Diabetes - Feasibility Study

NCT ID: NCT00922402

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2011-09-30

Brief 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.

Detailed Description

Heart failure is a common disease (prevalence worldwide: 22 million; incidence worldwide: 2 million; prevalence in Italy: 750.000; incidence in Italy: 170.000), affecting 1-2% of overall population and accounting for a significant proportion of healthcare costs. Recurrent hospital admissions represent the majority of the disease-related cost. About 15-25% of patients with HF are diabetics: the presence of diabetes significantly worsens prognosis in patients with heart failure and increases the risk of death by 30% compared to subject without diabetes.

The intensive control of glycemia during acute heart failure is an objective of primary importance, which can be obtained only with a proper strategy of patient management and with a considerable organizational effort. In a shared protocol aimed at a tight control of glycemia, the use of Continuous Glucose Monitoring (CGM) is expected to allow an easier management of the patient and a more accurate implementation of the protocol.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

All patients will be submitted to a shared intensive protocol of insulin infusion supported by continuous glucose monitoring

Group Type: EXPERIMENTAL

Intensive insulin infusion

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• acute heart failure, defined according to current ESC Guidelines
• HbA1c > 7.5% at admission in Cardiology Unit
• glycemia > 180 mg/dL at admission in Cardiology Unit
• the patients signed the Informed Consent

Exclusion Criteria

• heart failure in acute infarction or cardiogenic shock
• creatinemia > 3.5 mg/dL at admission or in hemodialytic therapy
• cirrhosis
• acute infective pathology
• cardiac revascularization during the hospitalization or in the preceding 3 months
• life expectance < 12 months
• age < 18 years
• pregnant women
• informed consent not signed
• subject included in other protocols

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Riccardo Vigneri, MD

Role: STUDY_CHAIR

Garibaldi-Nesima Hospital - Catania - Italy

Maddalena Lettino, MD

Role: STUDY_CHAIR

Policlinico S. Matteo - Pavia - Italy

Michele Gulizia, MD

Role: STUDY_CHAIR

Garibaldi-Nesima Hospital - Catania - Italy

Luigi Magnani, MD

Role: STUDY_CHAIR

Policlinico S. Matteo - Pavia - Italy

Luigi Tavazzi, MD

Role: STUDY_CHAIR

Ospedale Villa Maria Cecilia - Gruppo Villa Maria - Cotignola (Ravenna) - Italy

Locations

Garibaldi Nesima Hospital

Catania, , Italy

Policlinico S. Matteo

Pavia, , Italy

Countries

Italy

Other Identifiers

Heart & Diabetes

Identifier Type: -

Identifier Source: org_study_id