임상 레이더 AI | ||
|---|---|---|
임상시험 NCT04430608 (CGM-ISO)은(는) 당뇨병, 코로나바이러스 감염증-19, 감염에 대해 완료 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
Remote Continues Glucose Monitoring During the COVID-19 Pandemic in Quarantined Hospitalized Patients (CGM-ISO) 64 무작위 배정 원격 참여
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT04430608 (CGM-ISO)은(는) 당뇨병, 코로나바이러스 감염증-19, 감염에 대해 알아본 중재연구입니다. 현재 상태는 완료입니다. 연구는 2020년 5월 25일에 시작되어 64명의 참여자와 함께 진행되었습니다. Nordsjaellands Hospital이(가) 진행한 이 연구는 2021년 4월 25일에 마무리되었습니다. ClinicalTrials.gov의 가장 최근 정보는 2024년 4월 5일에 갱신되었습니다.
간단한 개요
This is a randomized controlled trial of isolated patients with diabetes admitted to Nordsjællands Hospital with or without COVID-19-pneumonia. A continuous glucose monitoring (CGM) based system with transmission of glucose data to a central system is used for remote monitoring of glucose levels and compared to standard finger-prick glucose. Blinded (to patients) CGM is mounted in the finger-prick group.
상세한 설명
Epidemics and pandemics are a constant threat to health care systems globally. This stresses the importance of preparedness for a large amount of hospitalized quarantined patients in isolation, with the extra challenges it brings. The COVID-19 pandemic challenges the Danish health care system in many aspects: An increased number of citizens are expected to be admitted to hospital due to COVID-19 infected pneumonia an...더 보기
공식 제목
Remote Glucose Monitoring of Patients With Diabetes Quarantined During the COVID-19 Pandemic - a Hospital-Based Randomized Controlled Trial of the Effect of Remote Continuous Glucose Monitoring Compared to Usual Glucose Monitoring
질환명
당뇨병코로나바이러스 감염증-19감염출판물
이 임상시험에 대해 발표된 과학 논문 및 연구 자료.기타 연구 식별자
- CGM-ISO
- H-20025305
NCT 번호
실제 연구 시작일
2020-05-25
최신 업데이트 게시
2024-04-05
예상 연구 완료일
2021-04-25
계획된 등록 인원
64
연구종류
중재연구
단계/상
해당 없음
상태
완료
키워드
endocrinology
diabetes
quarentine
isolation
CGM
diabetes
quarentine
isolation
CGM
주요 목적
기타
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
기타Fingerprick glucose Standard care with fingerprick glucose + blinded CGM stratification on COVID-19 status | Dexcom G6 The investigational device is a CGM Dexcom G6. The Dexcom G6 System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. The device-system consists of a sensor, the Dexcom G6 device/sender, and connects to a smart device like a cellphone. The Dexcom G6 CGM system is probably the most precise system on the market and with no need for daily calibration with finger prick glucose. Th...더 보기 |
실험적Open continous glucose monitoring (CGM) Standard care with fingerprick glucose + un-blinded CGM stratification on COVID-19 status | Dexcom G6 The investigational device is a CGM Dexcom G6. The Dexcom G6 System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. The device-system consists of a sensor, the Dexcom G6 device/sender, and connects to a smart device like a cellphone. The Dexcom G6 CGM system is probably the most precise system on the market and with no need for daily calibration with finger prick glucose. Th...더 보기 |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Time In Range (TIR) for blood glucose | TIR is presented in percent of time in which the participants' glucose values are in different glucose ranges. | 1-2 weeks |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Saved patient-personnel contacts related to blood glucose measurements. | Saved patient-personnel contacts related to blood glucose measurements, incl. time healthcare providers spent on diabetes related tasks and PPE related tasks, during the patients' hospitalization. | 1-2 weeks |
Glucose variations during hospitalization | Additional glucose outcomes based on data from Dexcom G6 are for example Time Above Range (TAR), Time Below Range (TBR), average glucose, variance in glucose (CV), etc. | 1-2 weeks |
Blood glucose lowering interventions | That is: Tablet-based and insulin-based regimens and number of times that sliding scale insulin (including dose of insulin) has been administered for each patient. | 1-2 weeks |
CGM sensor performance | Number of techincal errors during the sensors lifetime. | 1-2 weeks |
Course of hospital stay. | Hospital death (yes/no), length of stay at hospital, need for respiratory support (yes/no) and intensive care (yes/no), recovered vs. fatal (death within 60 days from admission). | 1-2 weeks |
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
- Hospitalized with confirmed COVID-19 infection by real-time PCR or another validated method OR hospitalized with a non-COVID-19 diagnosis AND in isolation at time of inclusion.
- A documented clinically relevant history of diabetes or newly discovered during hospitalization.
- Written informed consent obtained before any trial related procedures are performed.
- Male or female aged over 18 years of age.
- Must be able to communicate with the study personnel.
- The subject must be willing and able to comply with trial protocol.
1. Known hypersensitivity to the band-aid of the Dexcom G6 sensors
Nordsjaellands Hospital연락처 정보가 없습니다.
1 1개국에 임상시험 장소
Nordsjællands Hospital, Hillerød, 3400, Denmark