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Continuous Glucose Monitoring in Hospitalized Patients With Diabetes Mellitus 142

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임상시험 NCT04653454은(는) 당뇨병에 대해 알아본 중재연구입니다. 현재 상태는 완료입니다. 연구는 2021년 1월 1일에 시작되어 142명의 참여자와 함께 진행되었습니다. 메이요 클리닉이(가) 진행한 이 연구는 2023년 11월 10일에 마무리되었습니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 7월 31일에 갱신되었습니다.
간단한 개요
The purpose of this study is to determine if patient's own Continuous Glucose Monitor (CGMs) worn in the non-ICU hospital setting have adequate accuracy for blood glucose monitoring when compared to point-of-care (POC) capillary glucose measurement, and to determine if alerts given by CGMs worn in the non-ICU hospital would prevent episodes of hyperglycemia and hypoglycemia.
상세한 설명
All patients admitted to the hospital in inpatient or observation status and having a Continuous Glucose Monitor (CGMs) attached will be screened and identified by providers and nurses. An order will be placed by providers to continue patient's home CGM use in the hospital. "CGM patient agreement" describing the hospital policy for use of CGMs will be provided to the patient for signature. Patients will be encouraged...더 보기
공식 제목

CGM Use in Hospitalized Patients With Diabetes Mellitus

질환명
당뇨병
기타 연구 식별자
  • 20-008826
NCT 번호
NCT04653454
실제 연구 시작일
2021-01-01
최신 업데이트 게시
2025-07-31
예상 연구 완료일
2023-11-10
계획된 등록 인원
142
연구종류
중재연구
단계/상
해당 없음
상태
완료
키워드
CGM, Continuous Glucose Monitor
주요 목적
진단
설계 할당
해당 없음
중재 모델
단일군설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
참가자 그룹/시험군개입/치료
실험적CGM Patients
Patients with diabetes mellitus admitted to the hospital and using a CGM will be encouraged to continue to use these devices in inpatient setting. The device alarms of high or low glucose levels will be communicated to the nursing staff.
Continuous Glucose Monitor (CGM)
CGM data will be downloaded prior to discharge and it will be compared with hospital glucometer readings taken at the same time.
주요결과변수
결과변수측정값 설명시간 범위
Continuous Glucose Monitors (CGM) Accuracy - Mean Absolute Relative Difference (MARD)
The absolute relative difference (ARD) was defined as the absolute difference between control - point of care (POC) glucose reading and the corresponding CGM reading divided by POC glucose reading and expressed as percentage. ARD was calculated as mean absolute relative difference (MARD) with standard deviation. MARD was calculated between matched pairs of POC (point of care) glucose readings and the closest CGM reading. MARD was summarized as mean (standard deviation) or median (range) for glucose readings \<70 mg/dl, 70-180 mg/dL, \>180 mg/dl, 181-250mg/dl, \>250 mg/dl respectively.
From date of enrollment and until discharge from the hospital up to 30 days.
이차결과변수
결과변수측정값 설명시간 범위
CGM Recorded Hypoglycemia Episodes
The incidence of hypoglycemic episodes
From date of enrollment and until discharge from the hospital up to 30 days.
CGM Recorded Duration of Hypoglycemic Episodes
CGM recorded duration of hypoglycemic episodes
From date of enrollment and until discharge from the hospital up to 30 days.
CGM Recorded Hyperglycemic Episodes
The incidence of hyperglycemic episodes
From date of enrollment and until discharge from the hospital up to 30 days.
CGM Recorded Duration of Hyperglycemic Episodes
The duration of hyperglycemic episodes
From date of enrollment and until discharge from the hospital up to 30 days.
Variation in Mean Absolute Relative Difference (MARD) in Relation to Pharmacological and Physiological Parameters
The correlation between MARD point of care (POC) and Creatinine, Glomerular Filtration Rate (GFR), Bicarbonate, Hemoglobin (Hb), Mean Arterial Pressure (MAP), and Peripheral Oxygen Saturation (SpO2). The Spearman's rank correlation method was used to calculate the correlation coefficient.
From date of enrollment and until discharge from the hospital up to 30 days.
In Hospital Mortality
Mortality during index hospitalization
From date of enrollment and until discharge from the hospital up to 30 days.
Hospitalization Length of Stay
Duration of hospital stay in hours
From date of enrollment and until discharge from the hospital up to 30 days.
Mortality Rate at 30 Days
Mortality rate at 30 days post discharge from the hospital
From date of enrollment up to 60 days.
Number of Re-hospitalization Events at the Same Institution Within 30 Days From the Discharge Date of the Preceding Admission.
Number of re-hospitalization events that occurred at the same institution within 30 days from the discharge date of the preceding admission.
From date of enrollment up to 60 days.
적격성 기준

연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
  • Patients with Type 1 or 2 Diabetes Mellitus,
  • Patients 18 years of age or older,
  • Patients admitted under medical or surgical services.
  • Patients treated with diet alone, insulin (SQ, insulin pump) or oral hypoglycemic medications.
  • Have their own Continuous Glucose Monitoring (CGM) monitor present on admission or able to be placed after admission.

  • Individuals under 18 years of age.
  • COVID-19 infection.
  • Infection of the skin at the CGM site requiring removal of the sensor.
  • Patients with altered Mental Status.
  • Patients unable to scan their flash CGMs at least every 8 hours.
  • Inability to provide written consent.
  • Hospitalized for less than 24 hours.
Mayo Clinic logo메이요 클리닉861개의 진행 중인 임상시험 탐색 가능
연구 책임자
Adrian G. Dumitrascu, 책임연구자, Principal Investigator, Mayo Clinic
연락처 정보가 없습니다.
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Mayo Clinic in Florida, Jacksonville, Florida, 32224, United States