- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02710617
System Accuracy Evaluation of 2 CE-marked Blood Glucose Monitoring System
The objective of this study is the evaluation of system accuracy following ISO 15197:2013 (E), clause 6.3 in which accuracy requirements and applicable test procedures for blood glucose monitoring systems intended for self-monitoring of blood glucose by patients are stipulated.
However in this study, system accuracy evaluation will be performed for Hemocue Glucose 201+ and Hemocue Glucose 201 RT which are both glucose monitoring systems for professional use only on behalf of the IDT with one reagent system lot for each BGMS.
Main goal is the evaluation of system accuracy of both of the hemocue Systems. (english)
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Ulm, 독일, 89081
- Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Male or female, with type 1 diabetes, type 2 diabetes or subjects without diabetes
- Signed informed consent form
- Minimum age of 18 years
- Subjects are legally competent and capable to understand character, meaning and consequences of the study.
- If blood glucose values < 80 mg/dl or > 300 mg/dl shall be measured after short term alteration in insulin therapy:
- Male or female with type 1 diabetes and intensified insulin therapy or insulin pump therapy.
- Signature of subjects to document consent with these procedures on informed consent form.
Exclusion Criteria:
- Pregnancy or lactation period
- Severe acute disease (at the study physician's discretion)
- Severe chronic disease with potential risk during the test procedures (at the study physician's discretion)
- Current constitution that compromises the subject's capability to participate in the study (at the study physician's discretion)
- Being unable to give informed consent
- < 18 years
- Legally incompetent
- Being committed to an institution (e.g. psychiatric clinic)
- Language barriers potentially compromising an adequate compliance with study procedures
- Dependent on investigator or sponsor
- If blood glucose values < 80 mg/dl shall be measured after short term alteration in insulin therapy (concentration category 2, see Fehler! Verweisquelle konnte nicht gefunden werden.), subjects with type 1 diabetes, suffering from:
- Coronary heart disease
- Condition after myocardial infarction
- Condition after cerebral events
- Peripheral arterial occlusive disease
- Hypoglycemia unawareness
공부 계획
연구는 어떻게 설계됩니까?
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
System accuracy criteria (see description)
기간: For each subject, the experimental phase has an expected duration of up to 6 hours
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System accuracy criteria
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For each subject, the experimental phase has an expected duration of up to 6 hours
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
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 연구와 관련된 용어
기타 연구 ID 번호
- IDT-1542-IU
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