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Heart & Diabetes - Feasibility Study

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT00922402
First received: June 16, 2009
Last updated: February 22, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention
Acute Heart Failure
 Procedure: Intensive insulin infusion

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Heart & Diabetes - Feasibility Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • Average time to glycemic target (90-130 mg/dL) [ Time Frame: Within two days after enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patient-days without deviations from the protocol [ Time Frame: Within two days after enrollment ] [ Designated as safety issue: No ]
  • Average glycemia in the first 6 hours [ Time Frame: Within six hours after enrollment ] [ Designated as safety issue: No ]
  • Slope of decremental curve of glycemia in the first 6 hours [ Time Frame: Within six hours after enrollment ] [ Designated as safety issue: No ]
  • Median number of glycemia controls/patient in the first 12 hours [ Time Frame: Within twelve hours after enrollment ] [ Designated as safety issue: No ]
  • Percentage of patients in glycemic range during the first 6 hours of infusion [ Time Frame: Within six hours after enrollment ] [ Designated as safety issue: No ]
  • Number of hypoglycemia episodes in the first 5 days [ Time Frame: Within five days after enrollment ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • HbA1c at 3 months and variation with respect to baseline [ Time Frame: Within three months after enrollment ] [ Designated as safety issue: No ]
  • Number of hypoglycemia episodes in the follow-up [ Time Frame: Within three months after enrollment ] [ Designated as safety issue: Yes ]
  • Evaluation of the number of finger-stick measurement and CGM readings [ Time Frame: Within five days after enrollment ] [ Designated as safety issue: No ]
  • Evaluation of the correlation between finger-stick measurement and CGM readings [ Time Frame: Within five days after enrollement ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Within five days after enrollment ] [ Designated as safety issue: No ]
  • Number of times that finger-stick overruled CGM readings or alarms not to do any therapy adjustment [ Time Frame: WIthin five days after enrollment ] [ Designated as safety issue: No ]
  • Evaluation of healthcare resource consumption [ Time Frame: Within three months after enrollment ] [ Designated as safety issue: No ]
  • Evaluation of organizational impact [ Time Frame: Within three months after enrollment ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: June 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00922402

Locations
Italy
Garibaldi Nesima Hospital
Catania, Italy
Policlinico S. Matteo
Pavia, Italy
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Francesco De Seta, Medtronic Italy
ClinicalTrials.gov Identifier: NCT00922402     History of Changes
Other Study ID Numbers: Heart & Diabetes
Study First Received: June 16, 2009
Last Updated: February 22, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by Medtronic Bakken Research Center:
Acute
heart failure
hyperglycemia
Acute heart failure with high levels of glycemia

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Insulin
 Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013