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임상시험 NCT03832907은(는) 당뇨병에 대해 완료 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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에머리 대학교Dexcom G6 Observational Study 101 관찰 연구
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 NCT03832907은(는) 당뇨병에 대해 알아본 중재연구입니다. 현재 상태는 완료입니다. 연구는 2019년 2월 21일에 시작되어 101명의 참여자와 함께 진행되었습니다. 에머리 대학교이(가) 진행한 이 연구는 2020년 3월 31일에 마무리되었습니다. ClinicalTrials.gov의 가장 최근 정보는 2021년 8월 5일에 갱신되었습니다.
간단한 개요
This is an exploratory prospective study primary aiming to evaluate differences between Point-of-care (POC) testing (standard of care) and Dexcom G6 CGM (Continues Glucose Monitoring sensor system) in 1) glycemic control measured by mean daily blood glucose and 2) identifying hypoglycemic and hyperglycemic events - in patients with type 1 and type 2 diabetes treated with basal bolus insulin regimen.
상세한 설명
Several studies have shown that the use of a device that can measure blood glucose levels every 5 minutes is more effective in identifying low blood glucose (hypoglycemia) and high blood glucose (hyperglycemia) when compared to regular measurements with fingersticks \[point of care (POC)\].
This is an exploratory prospective study primary aiming to evaluate differences between Point-of-care (POC) testing (standard o...
더 보기공식 제목
Inpatient and Post-hospital Discharge Assessment of Glycemic Control by Capillary Point-of-care Glucose Testing and by Continuous Glucose Monitoring in Insulin-treated Patients With Type 1 and Type 2 Diabetes: Dexcom G6 Observational Study
질환명
당뇨병기타 연구 식별자
- IRB00107627
NCT 번호
실제 연구 시작일
2019-02-21
최신 업데이트 게시
2021-08-05
예상 연구 완료일
2020-03-31
계획된 등록 인원
101
연구종류
중재연구
단계/상
해당 없음
상태
완료
키워드
Glucose monitoring
POC BG
DexcomG6 CGM
POC BG
DexcomG6 CGM
주요 목적
진단
설계 할당
해당 없음
중재 모델
단일군설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Dexcom G6 CGM - Continues Glucose Monitoring sensor system The Dexcom G6 CGM is a commercially available factory-calibrated sensor system. The system measures interstitial glucose every 5-15 minutes, providing real-time and more complete glycemic profile during 24-hours compared to standard POC glucose testing, and replaces the need for finger sticking. Potential limitations include the need for removing the sensor before MRI or diathermy treatment, and the potential interfe...더 보기 | Dexcom G6 CGM - Continues Glucose Monitoring sensor system A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital disch...더 보기 POC BG - Point-of-Care Blood Glucose monitoring Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days. |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Mean Daily Blood Glucose by POC Reading сompared to CGM Reading | Mean daily blood glucose will be calculated | During hospital stay (3 days - up to 30 days) |
Number of Clinical Significant Hypoglycemia (<54 mg/dl) Events by POC Reading Compared to CGM Reading | Number of clinical significant hypoglycemia (\<54 mg/dl) events will be calculated | During hospital stay (3 days - up to 30 days) |
Number of Severe Hyperglycemia (>240 mg/dl) Events by POC Reading Compared to CGM Reading | Number of severe hyperglycemia (\>240 mg/dl) events will be recorded | During hospital stay (3 days - up to 30 days) |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Mean Daily Blood Glucose by POC Reading Compared to CGM Reading | Mean daily blood glucose will be calculated | 10 days post discharge |
Number of Clinical Significant Hypoglycemia (<54 mg/dl) Events by POC Reading Compared to CGM Reading | Number of clinical significant hypoglycemia (\<54 mg/dl) events will be calculated | 10 days post discharge |
Number of Clinical Significant Severe Hyperglycemia (>240 mg/dl) Events by POC Reading Compared to CGM Reading | Number of severe hyperglycemia (\>240 mg/dl) events will be recorded | 10 days post discharge |
Number of Nocturnal Hypoglycemic Events < 70 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading | Number of nocturnal hypoglycemic events \< 70 mg/dl (between 22:00 and 06:00) will be recorded | During hospital stay (3 days - up to 30 days) |
Number of Nocturnal Hypoglycemic Events < 70 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading | Number of nocturnal hypoglycemic events \< 70 mg/dl(between 22:00 and 06:00) will be recorded | 10 days post discharge |
Number of of Hypoglycemic Events < 70mg/dl in POC Group by POC Reading Compared to CGM Reading | Number of of hypoglycemic events \< 70mg/dl will be recorded | During hospital stay (3 days - up to 30 days) |
Number of Hypoglycemic Events < 70mg/dl by POC Reading Compared to CGM Reading | Number of of hypoglycemic events \< 70mg/dl will be recorded | 10 days post discharge |
Time in Hypoglycemia (Minutes) During the Day and Night by CGM Reading | Time in hypoglycemia (minutes) during the day and night will be recorded. Only measured by CGM, Discrete POC values are not used to assess amount of time spent within a specific glucose range. . | During hospital stay (3 days - up to 30 days) |
Time in Hypoglycemia (Minutes) During the Day and Night by CGM Reading | Time in hypoglycemia (minutes) during the day and night will be recorded. Only measured by CGM, Discrete POC values are not used to assess amount of time spent within a specific glucose range. . | 10 days post discharge |
Time in Hyperglycemia (Minutes) During the Day and Night> 240 mg/dl by CGM Reading | Time in hyperglycemia (minutes) during the day and night\> 240 mg/dl will be recorded. Only measured by CGM, Discrete POC values are not used to assess amount of time spent within a specific glucose range. . | During hospital stay (3 days - up to 30 days) |
Time in Hyperglycemia (Minutes) During the Day and Night> 240 mg/dl by CGM Reading | Time in hyperglycemia (minutes) during the day and night\> 240 mg/dl will be recorded. Only measured by CGM, Discrete POC values are not used to assess amount of time spent within a specific glucose range. | 10 days post discharge |
Number of Hyperglycemic Events > 240 mg/dl by POC Reading Compared to CGM Reading | Number of hyperglycemic events \> 240 mg/dl will be recorded | During hospital stay (3 days - up to 30 days) |
Number of Hyperglycemic Events > 240 mg/dl by POC Reading Compared to CGM Reading | Number of hyperglycemic events \> 240 mg/dl will be recorded | 10 days post discharge |
Percentage of BG Readings Within Target BG of 70 and 180 mg/dl by POC Reading Compared to CGM Reading | Percentage of BG readings within target BG of 70 and 180 mg/dl will be calculated | During hospital stay (3 days - up to 30 days) |
Percentage of BG Readings Within Target BG of 70 and 180 mg/dl by POC Reading Compared to CGM Reading | Percentage of BG readings within target BG of 70 and 180 mg/dl will be calculated | 10 days post discharge |
Percentage of Patients With Greater Than 5%-Time Below Glucose Target <70mg/dl by CGM Reading | Percentage of patients with greater than 5%-time below glucose target \<70mg/dl will be calculated. Only measured by CGM, Discrete POC values are not used to assess amount of time spent within a specific glucose range. | During hospital stay (3 days - up to 30 days) |
Percentage of Patients With Greater Than 5%-Time Below Glucose Target <70 mg/dl by CGM Reading | Percentage of patients with greater than 5%-time below glucose target \<70 mg/dl will be calculated | 10 days post discharge |
Percentage of Patients With Greater Than 5%-Time Above Glucose Target >180mg/dl by CGM Reading | Percentage of patients with greater than 5%-time above glucose target \>180 mg/dl will be calculated | During hospital stay (3 days - up to 30 days) |
Percentage of Patients With Greater Than 5%-Time Above Glucose Target >180 mg/dl by CGM Reading | Percentage of patients with greater than 5%-time above glucose target \>180 will be calculated | 10 days post discharge |
Glycemic Variability Calculated by Standard Deviation by CGM Reading | Glycemic variability will be calculated using Standard Deviation | During hospital stay (3 days - up to 30 days) |
Glycemic Variability Calculated by MAGE by CGM Reading | MAGE: average amplitude of glycemic excursions with values exceeding a certain threshold. | 10 days post discharge |
Number of Sensor Removal/Failures/Dislodgments | Number of sensor removal/failures/dislodgments will be recorded | During hospital stay (3 days - up to 30 days) |
Mean Absolute Relative Difference (MARD) of CGM Compared to POC | Accuracy of Dexcom G6 CGM, as defined by overall MARD, compared to POC | During hospital stay (3 days - up to 30 days) |
Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values < 70 mg/d Compared to the Standard-of-care POC BG | Percentage of CGM glucose values in the hypoglycemic range (\<70 mg/dl) meeting %30/30 accuracy criteria. | During hospital stay (3 days - up to 30 days) |
Percentage of Values Within Zone A, B, C, D of the Clarke Error Grid Measured in Abdomen | Percentage of CGM glucose values within defined performance zones (A-E) indicating potential for clinical error. The Clarke error grid analysis uses a Cartesian diagram, in which the estimated/predicted values are displayed on the y-axis, whereas the reference values are presented on the x-axis. This diagram is subdivided into 5 zones: A, B, C, D, and E. The points that fall within zones A and B represent, respectively, sufficiently accurate and acceptable glucose results (better outcome), points in zone C may prompt unnecessary corrections, points in zones D and E represent erroneous and incorrect treatment. | During hospital stay (3 days - up to 30 days) |
Percentage of Values Within Zone A, B, C of the Clarke Error Grid Measured in Arm | Percentage of CGM glucose values within defined performance zones (A-E) indicating potential for clinical error. The Clarke error grid analysis uses a Cartesian diagram, in which the estimated/predicted values are displayed on the y-axis, whereas the reference values are presented on the x-axis. This diagram is subdivided into 5 zones: A, B, C, D, and E. The points that fall within zones A and B represent, respectively, sufficiently accurate and acceptable glucose results (better outcome), points in zone C may prompt unnecessary corrections, points in zones D and E represent erroneous and incorrect treatment. | During hospital stay (3 days - up to 30 days) measured in arm |
Number of Nocturnal Hypoglycemic Events < 54 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading | Number of nocturnal hypoglycemic events \< 54 mg/dl (between 22:00 and 06:00) will be recorded | During hospital stay (3 days - up to 30 days) |
Number of Nocturnal Hypoglycemic Events < 54 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading | Number of nocturnal hypoglycemic events \< 54 mg/dl(between 22:00 and 06:00) will be recorded | 10 days post discharge |
Number of of Hypoglycemic Events < 54 in POC Group by POC Reading Compared to CGM Reading | Number of of hypoglycemic events \< 54 will be recorded | During hospital stay (3 days - up to 30 days) |
Number of Hypoglycemic Events < 54mg/dl by POC Reading Compared to CGM Reading | Number of of hypoglycemic events \< 54mg/dl will be recorded | 10 days post discharge |
Percentage of Patients With Greater Than 5%-Time Below Glucose Target <54mg/dl by CGM Reading | Percentage of patients with greater than 5%-time below glucose target \<54mg/dl will be calculated. Only measured by CGM, Discrete POC values are not used to assess amount of time spent within a specific glucose range. | During hospital stay (3 days - up to 30 days) |
Percentage of Patients With Greater Than 5%-Time Above Glucose Target >240 mg/dl by CGM Reading | Percentage of patients with greater than 5%-time above glucose target \>240 will be calculated | 10 days post discharge |
Percentage of Patients With Greater Than 5%-Time Above Glucose Target >240 mg/dl by CGM Reading | Percentage of patients with greater than 5%-time above glucose target \>240 mg/dl will be calculated | During hospital stay (3 days - up to 30 days) |
Glycemic Variability Calculated by MAGE by CGM Reading | The average amplitude of glycemic excursions with values exceeding a certain threshold. | During hospital stay (3 days - up to 30 days) |
Percentage of Patients With Greater Than 5%-Time Below Glucose Target <54 mg/dl by CGM Reading | Percentage of patients with greater than 5%-time below glucose target \<54 mg/dl will be calculated | 10 days post discharge |
Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG | Percentage of CGM glucose values within the 70-140 mg/dl range that meet %30/30 accuracy criteria. | During hospital stay (3 days - up to 30 days) |
Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG | Percentage of CGM glucose values within the 140-180 mg/dl range that meet %30/30 accuracy criteria. | During hospital stay (3 days - up to 30 days) |
Percentage of Dexcom G6 CGM Sensor Values Within 30/30%for Values > 180 mg/dl, Compared to the Standard-of-care POC BG | Percentage of CGM glucose values in the hyperglycemic range (\>180 mg/dl) that meet %30/30 accuracy criteria. | During hospital stay (3 days - up to 30 days) |
Glycemic Variability Calculated by Standard Deviation by CGM Reading | Glycemic variability will be calculated using Standard Deviation | 10 days post discharge |
Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values < 70 mg/dl Compared to the Standard-of-care POC BG | Percentage of CGM glucose values in the hypoglycemic range (\<70 mg/dl) that meet %20/20 accuracy criteria. | During hospital stay (3 days - up to 30 days) |
Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG | Percentage of CGM glucose values within the 70-140 mg/dl range that meet %20/20 accuracy criteria. | During hospital stay (3 days - up to 30 days) |
Percentage of Dexcom G6 CGM Sensor Values Within 20/20%for Values > 180 mg/dl, Compared to the Standard-of-care POC BG | Percentage of CGM glucose values in the hyperglycemic range (\>180 mg/dl) that meet %20/20 accuracy criteria.. | During hospital stay (3 days - up to 30 days) |
Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG | Percentage of CGM glucose values within the 140-180 mg/dl range that meet %20/20 accuracy criteria. | During hospital stay (3 days - up to 30 days) |
Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values < 70 mg/dl Compared to the Standard-of-care POC BG | Percentage of CGM glucose values in the hypoglycemic range (\<70 mg/dl) that meet %15/15 accuracy criteria.. | During hospital stay (3 days - up to 30 days) |
Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG | Percentage of CGM glucose values within the 70-140 mg/dl range that meet %15/15 accuracy criteria. | During hospital stay (3 days - up to 30 days) |
Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG | Percentage of CGM glucose values within the 140-180 mg/dl range that meet %15/15 accuracy criteria. | During hospital stay (3 days - up to 30 days) |
Percentage of Dexcom G6 CGM Sensor Values Within 15/15%for Values > 180 mg/dl, Compared to the Standard-of-care POC BG | Percentage of CGM glucose values in the hyperglycemic range (\>180 mg/dl) that meet %15/15 accuracy criteria. | During hospital stay (3 days - up to 30 days) |
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
- > 18 years admitted to a general medicine or surgical service.
- Known history of T1D or T2D receiving insulin therapy
- Subjects must have a randomization BG between 140 mg and 400 mg/dL without laboratory evidence of diabetic ketoacidosis (bicarbonate < 18 mEq/L, pH < 7.30, or positive serum or urinary ketones).
- Patients with expected hospital length-of-stay of 3 or more days
- Patients with acute illness admitted to the ICU or expected to require admission to the ICU.
- Patients expected to require MRI procedures during hospitalization.
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- Female subjects who are pregnant or breast-feeding at time of enrollment into the study.
에머리 대학교398개의 진행 중인 임상시험 탐색 가능연구 책임자
Guillermo Umpierrez, MD, 책임연구자, Professor, Emory University
연락처 정보가 없습니다.
1 1개국에 임상시험 장소
Georgia
Emory University, Atlanta, Georgia, 30322, United States