- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01634997
Evaluation of SCOUT DS Device in the Diagnosis of Diabetes
An Evaluation of the SCOUT DS Device. Random Capillary Glucose and Leicester Diabetes Risk Score for Screening Subjects at Risk for Type 2 Diabetes
연구 개요
상태
정황
상세 설명
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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West Yorkshire
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Keighley, West Yorkshire, 영국, BD20 6TD
- 모병
- Airedale General Hospital
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연락하다:
- Richard Pope, MD
- 전화번호: 01535292760
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Age greater than or equal to 45 years
OR
Age 18 to 44 years and BMI > 25 kg/m² with one or more of the following risk factors:
- Elevated waist circumference, > 35 inches for women and >40 inches for men
- Habitually physically inactive (does not exercise regularly)
- Has a first-degree relative with diabetes
- Ethnicity with elevated risk for type 2 diabetes
- Has delivered a baby weighing > 9 lb or diagnosed with gestational diabetes
- Hypertension (≥130/≥ 85 mmHg) or being treated for hypertension
- HDL cholesterol level < 35 mg/dL and/or a fasting triglyceride level ≥ 250 mg/dL or being treated for dyslipidemia with medication
- Has been previously diagnosed with Polycystic Ovary Syndrome (PCOS)
- Had impaired glucose tolerance or impaired fasting glucose on previous testing within the last 3 yrs
- Conditions associated with insulin resistance such as acanthosis nigricans
- History of vascular disease including heart attack, stroke, angina, coronary heart disease, atherosclerosis, congestive heart failure or peripheral arterial disease
Exclusion Criteria:
Under 18 years of age
- Receiving investigational treatments in the past 14 days
- Psychosocial issues that interfere with an ability to follow study procedures
- Conditions that cause secondary diabetes including Cushing's syndrome, acromegaly, hemochromatosis, pancreatitis, or cystic fibrosis
- Diagnosed with any type of diabetes, including type 1 or 2
- Taking glucose lowering medications with the exception of metformin
- Known to be pregnant
- Receiving dialysis or having known renal compromise
- Scars, tattoos, rashes or other disruption/discoloration on the left volar forearm.
- Recent (within past month) or current oral steroid therapy or topical steroids applied to the left forearm; inhaled steroid therapy is not excluded
- Current chemotherapy, or chemotherapy within the past 12 months
- Known to have, or at risk for, photosensitivity reactions ( e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Hemoglobin A1c
기간: Up to 6 months
|
A point of care A1c measurement will serve as the reference method for defining pre-diabetes (6.0% ≤ A1c ≤6.4%) and diabetes (A1c ≥ 6.5%) The study will require one visit by each subject to the clinical site. The visit does not require fasting and can be done any time of day. The study (not including the IRB process and recruiting) is expected to last 6 months. The target cohort comprises persons at risk for pre-diabetes and/or type 2 diabetes. |
Up to 6 months
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Richard Pope, MD, Airedale General Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
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