StatStrip Glucose/Ketone Meter System Ketone Evaluation
調査の概要
詳細な説明
The primary objectives of this study are:
- To assess the performance of the StatStrip Ketone assay in the hands of CLIA-Waived Point-of-Care users in at least three (3) distinct Point-of-Care clinical settings on venous, and capillary blood and compare the performance characteristics to a traceable laboratory reference method.
- To assess the Ease of Use of the StatStrip Glucose / Ketone Meter System in the hands of the intended CLIA-Waived Point-of-Care users. CLIA-Waived operators will be provided with all package-insert sheets, a Quick Reference Guide and Instructions for Use (IFU) Manual. No training, coaching, or prompting will be provided to the CLIA-Waived POC Users other than clarifying the protocol.
研究の種類
入学 (実際)
連絡先と場所
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
a minimum of 360 to a maximum of 500 individual subjects will be enrolled to test both capillary and venous whole blood. Subjects included in the study may be healthy, diabetic or suspected of ketonemia. The study will be conducted in at least three (3) separate study sites, with each site targeting 120 patients up to 200 patients.
Adult subjects (≥ 18 years old) of both genders will be included in this study.
Potential subjects may be screened prior to testing to assess their baseline ketone levels. The screening may be done by inspecting medical records, fingerstick ketone testing or urine dipstick testing. Each site shall follow their own specified procedures and protocols for the screening test method, if applicable.
説明
Inclusion Criteria:
- Adult subjects (≥ 18 years old) with diabetes or suspected ketonemia.
- Adult subjects (≥ 18 years old) that are healthy.
- Subjects willing and able to consent to participating in the study.
- Subjects whose pre-screen ketone value, if performed, is deemed valuable to the study.
Exclusion Criteria:
- Subjects unable to consent to participating in the study.
- Subjects possessing a cognitive disorder or other condition, which, in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study.
研究計画
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Analytical verification of StatStrip glucose/ketone meter system - ketone comparison
時間枠：20 days
|
StatStrip ketone meter system, a point of care testing instrument is as effective as a reference laboratory method for ketone results in mmol/L
|
20 days
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Jeremy Bleicher, MD、South Florida Research Organization
- 主任研究者：Peter Luppa、Technical University of Munich - Diabetes Hospital
- 主任研究者：Peter Luppa、Technical University of Munich - Emergency Reception
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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