- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04417270
Reliability of the Freestyle Libre CGM in the Inpatient Setting During the COVID-19 Surge
연구 개요
상세 설명
In hospitalized patients diagnosed with COVID-19, diabetes mellitus is associated with a higher mortality. Patients with controlled blood glucose have a lower mortality rate than those who are uncontrolled. However, a rigid blood glucose control - which may lead to hypoglycemia- is associated with higher mortality rates. Thus, adequate glucose monitoring is important for hospitalized diabetic patients.
Previous studies have shown that CGMS, in the outpatient setting, engender better glycemic control thereby reducing risk of hypoglycemia. CGMS offer a replacement for finger stick blood glucose monitoring which may not identify an incidence of hypoglycemia until symptoms drive the patient to test. Furthermore, finger stick blood glucose monitoring is painful and time consuming thus causing many patients to avoid this aspect of diabetes self-care management.
Freestyle Libre CGMs sample interstitial fluid glucose subcutaneously. Measurement frequencies typically range from 1 to 15 minutes and most commonly are every 5 minutes.
Previous studies in hospitalized patients living with diabetes mellitus on basal bolus regimen have shown:
• Use of the CGM increased detection of both hypoglycemic and hyperglycemic events versus those sensed by POCT.
One investigation identified 88 postprandial hyperglycemic excursions in patients with CGM use as opposed to 61 in those with POCT. Another noted that when comparing the CGM use with that of POCT, the former identified 55 hypoglycemic events whereas the latter only found 12.
• No difference in mean daily glucose CGM and POCT readings. In a study of 38 patients, the investigators noted no difference in mean daily glucose between the CGM and POCT.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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New York
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New York, New York, 미국, 10022
- Lenox Hill Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Participants acquired from among all non-critical care in patients who are living with Diabetes Mellitus. Because the patients will have to be instructed on the use of the CGM, this study will be limited to English speaking/reading adults (18 years of age or older), who possess the cognitive and physical ability to participate.
Exclusion Criteria:
- Minors, pregnant women, and critically ill.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위화되지 않음
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: Freestyle Libre 14-day CGM
The FreeStyle Libre 14 day system is a continuous glucose monitoring system consisting of a handheld reader and a sensor worn on the back of the upper arm.
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The FreeStyle Libre 14 day system is a continuous glucose monitoring system consisting of a handheld reader and a sensor worn on the back of the upper arm.
The Accu-Chek Inform II system is designed to deliver data with speed and efficiency, helping to provide optimal care.
Wireless meter quickly transfers data.
The Accu-Chek Inform II system is the first point-of-care blood glucose device to offer truly wireless technology at the meter level.
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다른: Accuchek Inform II meter
ACCU-CHEK INFORM II system quantitatively measures glucose in fresh venous, arterial, neonatal heel stick and capillary whole blood from the finger and is used as an aid in monitoring the effectiveness of glucose control
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The FreeStyle Libre 14 day system is a continuous glucose monitoring system consisting of a handheld reader and a sensor worn on the back of the upper arm.
The Accu-Chek Inform II system is designed to deliver data with speed and efficiency, helping to provide optimal care.
Wireless meter quickly transfers data.
The Accu-Chek Inform II system is the first point-of-care blood glucose device to offer truly wireless technology at the meter level.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Comparison of values between two devices
기간: Through end of patient hospitalization, an average of 14 days
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Correlation between blood glucose results from the Freestlye Libre 14-day CGM and Accuchek Inform II platform using the Bland-Altman method to determine whether the two glucose methods agree
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Through end of patient hospitalization, an average of 14 days
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Renee Murray-Bachmann, Ed.D, MSN, Northwell Health
간행물 및 유용한 링크
유용한 링크
- Flash Glucose-Sensing Technology as a Replacement for Blood Glucose Monitoring for the Management of Insulin-Treated Type 2 Diabetes: A Multicenter, Open-Label Randomize
- Zhu, L., Zhi-Gang, S., Cheng, S., Guo, J., Bing-Hong, Z.,Hongliang, L. (2020).Association of blood glucose control and outcomes in patients with COVID-19 and pre-existing Type 2 Diabetes Cell Metabolism, 31, (2020).pp.1-10
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 20-0455
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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. .
진성 당뇨병에 대한 임상 시험
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Fondazione Policlinico Universitario Agostino Gemelli...아직 모집하지 않음비만 | 제2형 당뇨병 | 인슐린 저항성 당뇨병 (Mellitus)
Freestyle Libre 14 day CGM system에 대한 임상 시험
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Palo Alto Medical FoundationEmory University; Abbott Diabetes Care모병
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Odense University HospitalZealand University Hospital모병