Heart & Diabetes - Feasibility Study

Medtronic

Status: Withdrawn

Conditions: Acute Heart Failure

Treatments: Procedure: Intensive insulin infusion

Study type: Interventional

Funder types: Industry

Identifiers

NCT00922402

Heart & Diabetes

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (all of the following inclusion criteria must be met for the patient to be enrolled in the study):

• 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 (if any of the following criteria are met, patients cannot be enrolled in the study):

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Treatment

Experimental group

Description:

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

Treatment:

Procedure: Intensive insulin infusion