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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | All patients will be submitted to a shared intensive protocol of insulin infusion supported by continuous glucose monitoring |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive insulin infusion | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Average time to glycemic target (90-130 mg/dL) | Within two days after enrollment |
| Measure | Description | 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 | |
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Inclusion Criteria (all of the following inclusion criteria must be met for the patient to be enrolled in the study):
Exclusion Criteria (if any of the following criteria are met, patients cannot be enrolled in the study):
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| Name | Affiliation | Role |
|---|---|---|
| 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 Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Garibaldi Nesima Hospital | Catania | Italy | ||||
| Policlinico S. Matteo |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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|
| 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 |
| Pavia |
| Italy |
| D009750 |
| Nutritional and Metabolic Diseases |