Heart & Diabetes - Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Average time to glycemic target (90-130 mg/dL)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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
排除标准
- •(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
结局指标
主要结局
Average time to glycemic target (90-130 mg/dL)
时间窗: Within two days after enrollment
次要结局
- 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)
- 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)
- 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 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)