Heart & Diabetes - Feasibility Study
연구 개요
상세 설명
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.
연구 유형
단계
- 해당 없음
연락처 및 위치
연구 장소
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Catania, 이탈리아
- Garibaldi Nesima Hospital
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Pavia, 이탈리아
- Policlinico S. Matteo
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Treatment
All patients will be submitted to a shared intensive protocol of insulin infusion supported by continuous glucose monitoring
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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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Average time to glycemic target (90-130 mg/dL)
기간: Within two days after enrollment
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Within two days after enrollment
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Number of patient-days without deviations from the protocol
기간: Within two days after enrollment
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Within two days after enrollment
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Average glycemia in the first 6 hours
기간: Within six hours after enrollment
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Within six hours after enrollment
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Slope of decremental curve of glycemia in the first 6 hours
기간: Within six hours after enrollment
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Within six hours after enrollment
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Median number of glycemia controls/patient in the first 12 hours
기간: Within twelve hours after enrollment
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Within twelve hours after enrollment
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Percentage of patients in glycemic range during the first 6 hours of infusion
기간: Within six hours after enrollment
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Within six hours after enrollment
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Number of hypoglycemia episodes in the first 5 days
기간: Within five days after enrollment
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Within five days after enrollment
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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
기간: Within five days after enrollment
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Within five days after enrollment
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HbA1c at 3 months and variation with respect to baseline
기간: Within three months after enrollment
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Within three months after enrollment
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Number of hypoglycemia episodes in the follow-up
기간: Within three months after enrollment
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Within three months after enrollment
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Evaluation of the number of finger-stick measurement and CGM readings
기간: Within five days after enrollment
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Within five days after enrollment
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Evaluation of the correlation between finger-stick measurement and CGM readings
기간: Within five days after enrollement
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Within five days after enrollement
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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
기간: Within five days after enrollment
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Within five days after enrollment
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Number of times that finger-stick overruled CGM readings or alarms not to do any therapy adjustment
기간: WIthin five days after enrollment
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WIthin five days after enrollment
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Evaluation of healthcare resource consumption
기간: Within three months after enrollment
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Within three months after enrollment
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Evaluation of organizational impact
기간: Within three months after enrollment
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Within three months after enrollment
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공동 작업자 및 조사자
수사관
- 연구 의자: Riccardo Vigneri, MD, Garibaldi-Nesima Hospital - Catania - Italy
- 연구 의자: Maddalena Lettino, MD, Policlinico S. Matteo - Pavia - Italy
- 연구 의자: Michele Gulizia, MD, Garibaldi-Nesima Hospital - Catania - Italy
- 연구 의자: Luigi Magnani, MD, Policlinico S. Matteo - Pavia - Italy
- 연구 의자: Luigi Tavazzi, MD, Ospedale Villa Maria Cecilia - Gruppo Villa Maria - Cotignola (Ravenna) - Italy
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- Heart & Diabetes
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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