Heart & Diabetes - Feasibility Study

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 Overview

• Status: Withdrawn
• Conditions: Acute Heart Failure
• Intervention / Treatment: Procedure: Intensive insulin infusion

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Catania, Italy
    • Garibaldi Nesima Hospital
  • Pavia, Italy
    • Policlinico S. Matteo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Average time to glycemic target (90-130 mg/dL)	Within two days after enrollment

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of patient-days without deviations from the protocol	Within two days after enrollment
Average glycemia in the first 6 hours	Within six hours after enrollment
Slope of decremental curve of glycemia in the first 6 hours	Within six hours after enrollment
Median number of glycemia controls/patient in the first 12 hours	Within twelve hours after enrollment
Percentage of patients in glycemic range during the first 6 hours of infusion	Within six hours after enrollment
Number of hypoglycemia episodes in the first 5 days	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	Within five days after enrollment
HbA1c at 3 months and variation with respect to baseline	Within three months after enrollment
Number of hypoglycemia episodes in the follow-up	Within three months after enrollment
Evaluation of the number of finger-stick measurement and CGM readings	Within five days after enrollment
Evaluation of the correlation between finger-stick measurement and CGM readings	Within five days after enrollement
Number of times that therapy was changed after finger-stick confirmation when CGM values or alarms were indicating a therapy adjustment needs to be made	Within five days after enrollment
Number of times that finger-stick overruled CGM readings or alarms not to do any therapy adjustment	WIthin five days after enrollment
Evaluation of healthcare resource consumption	Within three months after enrollment
Evaluation of organizational impact	Within three months after enrollment

Collaborators and Investigators

• Sponsor: Medtronic Bakken Research Center
• Investigators: Study Chair: Riccardo Vigneri, MD, Garibaldi-Nesima Hospital - Catania - Italy; Study Chair: Maddalena Lettino, MD, Policlinico S. Matteo - Pavia - Italy; Study Chair: Michele Gulizia, MD, Garibaldi-Nesima Hospital - Catania - Italy; Study Chair: Luigi Magnani, MD, Policlinico S. Matteo - Pavia - Italy; Study Chair: Luigi Tavazzi, MD, Ospedale Villa Maria Cecilia - Gruppo Villa Maria - Cotignola (Ravenna) - Italy

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: June 16, 2009
• First Submitted That Met QC Criteria: June 16, 2009
• First Posted (Estimate): June 17, 2009

Study Record Updates

• Last Update Posted (Estimate): March 24, 2016
• Last Update Submitted That Met QC Criteria: March 23, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: heart failure; hyperglycemia; Acute; Acute heart failure with high levels of glycemia
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: Heart & Diabetes