임상 레이더 AI | ||
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임상시험 NCT03808376 (PROMISE)은(는) 당뇨병, 제1형 당뇨병, 제2형 당뇨병에 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
PROMISE Study: An Evaluation of an Implantable Continuous Glucose Sensor up to 180 Days 208
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 NCT03808376 (PROMISE)은(는) 당뇨병, 제1형 당뇨병, 제2형 당뇨병에 대해 알아본 중재연구입니다. 현재 상태는 완료입니다. 연구는 2018년 12월 27일에 시작되어 208명의 참여자와 함께 진행되었습니다. Senseonics, Inc.이(가) 진행한 이 연구는 2020년 5월 8일에 마무리되었습니다. ClinicalTrials.gov의 가장 최근 정보는 2024년 8월 20일에 갱신되었습니다.
간단한 개요
The purpose of this clinical investigation is to evaluate the accuracy of the Eversense® continuous Glucose Monitoring System (Eversense® 180 CGM System) measurements when compared with reference standard measurements up to 180 days of sensor use.
The investigation will also evaluate safety of the Eversense® 180 CGM System usage.
공식 제목
PROMISE Study: A Prospective, Multicenter Evaluation of Accuracy and Safety of an Implantable Continuous Glucose Sensor Lasting up to 180 Days
질환명
당뇨병제1형 당뇨병제2형 당뇨병기타 연구 식별자
- PROMISE
- CTP-0036
NCT 번호
실제 연구 시작일
2018-12-27
최신 업데이트 게시
2024-08-20
예상 연구 완료일
2020-05-08
계획된 등록 인원
208
연구종류
중재연구
단계/상
해당 없음
상태
완료
주요 목적
진단
설계 할당
해당 없음
중재 모델
단일군설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Continuous Glucose Monitoring Device The Eversense® 180 CGM System | Continuous Glucose Monitoring System The Eversense® 180 CGM System |
주요결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Effectiveness Measure - Mean Absolute Relative Difference (MARD) for Paired CGM and Reference Glucose Measurements | The effectiveness endpoint is the mean absolute relative difference (MARD), calculated for paired CGM Sensor and reference glucose measurements through 180 days post-sensor insertion for reference glucose values from 40-400 mg/dL. MARD is defined as the average of absolute difference of paired Sensor and reference glucose readings divided by the reference glucose reading (reference) for reference glucose values from 40-400 mg/dL, that is: MARD = ((SUM \| (Glucose)sensor - (Glucose)reference \| / (Glucose)reference ) / n ) x 100%, where n is the total number of Sensor and reference glucose pairs after 180 days of sensor use (MARD is expressed as a percent). Lower MARDs indicate higher (better) accuracy. | 180 days |
Safety Endpoint - Incidence of Device-related or Sensor Insertion/Removal Procedure-related Serious Adverse Events | Incidence of device-related or sensor insertion/removal procedure-related serious adverse events occurring up to 180 days after the insertion procedure. | 180 days |
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
- Adult subjects, age ≥18 years
- Clinically confirmed diagnosis of diabetes mellitus for ≥1 year
- Subject has signed an informed consent form and is willing to comply with protocol requirements
- History of unexplained severe hypoglycemia in the previous 6 months. Severe hypoglycemia is defined as hypoglycemia resulting in loss of consciousness or seizure
- History of diabetic ketoacidosis requiring emergency room visit or hospitalization in the previous 6 months
- Subjects with gastroparesis
- Female subjects of childbearing capacity (defined as not surgically sterile or not menopausal for ≥ 1 year) who are lactating or pregnant, intending to become pregnant, or not practicing birth control during the course of the study.
- A condition preventing or complicating the placement,operation, or removal of the Sensor or wearing of transmitter, including upper extremity deformities or skin condition.
- Symptomatic coronary artery disease; unstable angina; myocardial infarction, transient ischemic attack or stroke in the past 6 months; uncontrolled hypertension (systolic>160 mm Hg or diastolic >100 mm Hg at time of screening); current congestive heart failure; history of cardiac arrhythmia (benign PACs and PVCs allowed). Subjects with asymptomatic coronary artery disease (e.g. CABG, stent placement or angioplasty) may participate if negative stress test within 1 year prior to screening and written clearance from Cardiologist documented.
- Hematocrit <30% or >60%
- History of hepatitis B, hepatitis C, or HIV
- Current treatment for a seizure disorder unless written clearance by neurologist to participate in study
- History of adrenal insufficiency
- Currently receiving (or likely to need during the study period): immunosuppressant therapy; chemotherapy; anticoagulant/antithrombotic therapy (excluding aspirin); glucocorticoids (excluding ophthalmic or nasal). This exclusion does include the use of inhaled glucocorticoids and the use of topical glucocorticoids (over sensor site only); antibiotic for chronic infection (e.g. osteomyelitis, endocarditis)
- A condition requiring or likely to require magnetic resonance imaging (MRI)
- Known topical or local anesthetic allergy
- Known allergy to glucocorticoids
- Any condition that in the investigator's opinion would make the subject unable to complete the study or would make it not in the subject's best interest to participate in the study. Conditions include but are not limited to psychiatric conditions, known current or recent alcohol abuse or drug abuse by subject history, a condition that may increase the risk of induced hypoglycemia or risk related to repeated blood testing. Investigator will supply rationale for exclusion
- Participation in another clinical investigation (drug or device) within 2 weeks prior to screening or intent to participate during the study period
- The presence of any other active implanted device (as defined further in protocol)
Senseonics, Inc.연락처 정보가 없습니다.
8 1개국에 임상시험 장소
California
John Muir Physician Network Clinical Research Center, Concord, California, 94520, United States
AMCR Institute Inc., Escondido, California, 92025, United States
Diablo Clinical Research, Walnut Creek, California, 94598, United States
Colorado
Barbara Davis Center for Diabetes, Aurora, Colorado, 80045, United States
Georgia
Atlanta Diabetes Care, Atlanta, Georgia, 30318, United States
Idaho
Rocky mountain Diabetes Center C/O Research Department, Idaho Falls, Idaho, 83404, United States
Texas
Clinical Trials of Texas, San Antonio, Texas, 78229, United States
Washington
Rainier Clinical Research Center, Renton, Washington, 98057, United States