Heart & Diabetes - Feasibility Study

Medtronic Cardiac Rhythm and Heart Failure

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Acute Heart Failure

Interventions

Intensive insulin infusionPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Garibaldi Nesima Hospital

Catania, Italy

Policlinico S. Matteo

Pavia, Italy

Outcomes

Primary Outcomes

Average time to glycemic target (90-130 mg/dL)

Time frame: Within two days after enrollment

Secondary Outcomes

Number of patient-days without deviations from the protocol

Time frame: Within two days after enrollment

Average glycemia in the first 6 hours

Time frame: Within six hours after enrollment

Slope of decremental curve of glycemia in the first 6 hours

Time frame: Within six hours after enrollment

Median number of glycemia controls/patient in the first 12 hours

Time frame: Within twelve hours after enrollment

Percentage of patients in glycemic range during the first 6 hours of infusion

Time frame: Within six hours after enrollment

Number of hypoglycemia episodes in the first 5 days

Time frame: Within five days after enrollment

Number of medical interventions and/or therapy variations based on blood glucose monitoring (finger-sticks) and/or suggested by interstitial continuous glucose monitoring glucose monitoring in the first 5 days

Time frame: Within five days after enrollment

HbA1c at 3 months and variation with respect to baseline

Time frame: Within three months after enrollment

Number of hypoglycemia episodes in the follow-up

Time frame: Within three months after enrollment

Data from ClinicalTrials.gov

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