Heart & Diabetes - Feasibility Study
- Conditions
- Acute Heart Failure
- Interventions
- Procedure: Intensive insulin infusion
- Registration Number
- NCT00922402
- Lead Sponsor
- Medtronic Bakken Research Center
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Intensive insulin infusion All patients will be submitted to a shared intensive protocol of insulin infusion supported by continuous glucose monitoring
- Primary Outcome Measures
Name Time Method Average time to glycemic target (90-130 mg/dL) Within two days after enrollment
- Secondary Outcome Measures
Name Time Method Number of patient-days without deviations from the protocol Within two days after enrollment Slope of decremental curve of glycemia in the first 6 hours Within six hours after enrollment Percentage of patients in glycemic range during the first 6 hours of infusion Within six hours after enrollment Median number of glycemia controls/patient in the first 12 hours Within twelve hours after enrollment HbA1c at 3 months and variation with respect to baseline Within three months 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 Evaluation of organizational impact Within three months after enrollment Average glycemia in the first 6 hours Within six hours after enrollment Number of hypoglycemia episodes in the first 5 days Within five days after enrollment Number of hypoglycemia episodes in the follow-up Within three months 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 Number of times that finger-stick overruled CGM readings or alarms not to do any therapy adjustment WIthin five days after enrollment Evaluation of the number of finger-stick measurement and CGM readings Within five days after enrollment Evaluation of healthcare resource consumption Within three months after enrollment
Trial Locations
- Locations (2)
Garibaldi Nesima Hospital
🇮🇹Catania, Italy
Policlinico S. Matteo
🇮🇹Pavia, Italy