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治験 NCT01111370（対象：糖尿病）は完了です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
タイル表示
Effectiveness and Safety Study of the DexCom™ G4 Continuous Glucose Monitoring System 60
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT01111370 は 介入研究 臨床試験 で、糖尿病 を対象とした研究でした。現在は 完了 です。2010年2月1日 に開始し、60 名の参加者 が参加しました。この試験は DexCom, Inc. によって主導され、2010年4月1日 に完了しました。ClinicalTrials.gov からの最新更新日は 2017年3月27日 です。
概要
The purpose of this study is to evaluate the safety and effectiveness of the G4 System when worn for up to 7-days by subjects >18 years-old with diabetes mellitus requiring insulin.
Device performance will be primarily evaluated in terms of the proportion of G4 System values that are within ±20% of YSI reference value for glucose levels >80 mg/dL and ±20 mg/dL at meter glucose levels <80 mg/dL. These G4-YSI match...
もっと見る詳細説明
This will be a non-randomized, single-armed study conducted in the United States. Following screening, a minimum of 60 to a maximum of 80 subjects at up to 4 clinical sites will be enrolled. All participants will wear the G4 Sensor for one 7-day wear period (~168 hours). A subset of 20-30 subjects will wear two G4 Systems (one of which will be blinded) during the 7-day wear period for the purposes of assessing preci...もっと見る
公式タイトル
Effectiveness and Safety Study of the DexCom™ G4 Continuous Glucose Monitoring System
疾患名
糖尿病その他の研究識別子
- PTL900360
NCT番号
開始日
2010-02
最終更新日
2017-03-27
終了予定日
2010-04
目標参加者数
60
試験の種類
介入研究
治験の相・段階
該当なし
状況
完了
キーワード
diabetes mellitus requiring insulin
主目的
その他
割付方法
該当なし
介入モデル
単一群割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的CGM continuous glucose monitoring system | DexCom™ G4 Continuous Glucose Monitoring System Continuous Glucose Monitoring System |
主要評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
the Proportion of G4 CGM System in Agreement With the Reference Standard | The proportion of G4 System values within (±) 20% of YSI reference value for glucose levels \>80 mg/dL and (±) 20 mg/dL at YSI glucose levels \<80 mg/dL. This is primarayly laboratory measurement outcome,and it is not measured by clinical outcome, for example, diagnosis, treatement and complication, and clinical effectiveness, etc. | Assessment done on either Day 1, 4 or 7 of the sensor wear period |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- Age 18 years or older;
- Have been diagnosed with insulin-requiring diabetes and are on multiple daily injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII) insulin therapy;
- Willing not to inject insulin or wear an insulin pump insertion set within 3 inches from the Sensor site during Sensor wear;
- Willing to use only the blood glucose meter provided to them for self-monitoring of blood glucose (SMBG) during Sensor wear;
- Willing to participate in one, 8-hour in-clinic session and be willing to take 4 fingersticks per hour and have 4 blood draws per hour for the entire 8-hour duration;
- Willing to take a minimum of 6 fingersticks per day during home use (2 for calibration purposes, 4 for comparative purposes);
- Willing to refrain from the use of acetaminophen during the Sensor insertion period and for at least 24-hours prior to Sensor insertion;
- Willing not to schedule a magnetic resonance (MRI) scan, computed tomography (CT) scan, or x-ray, for the duration of the study;
- Able to speak, read, and write English.
- Have extensive skin changes/diseases that preclude wearing the Sensor on normal skin (e.g. extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites;
- Subjects who have a known allergy to medical-grade adhesives;
- Are pregnant as demonstrated by a positive pregnancy test within 72 hours of insertion;
- Have a hematocrit that is less than 30%, or greater than 55%;
- Current participation in another investigational study protocol (if a subject has recently completed participation in another drug study, the subject must have completed that study at least 30 days prior to being enrolled in this study);
- Have any condition that, in the opinion of the Investigator, would interfere with their participation in the trial or pose an excessive risk to study staff handling venous blood samples (e.g., known history of hepatitis B or C).
DexCom, Inc.連絡先情報がありません。
位置情報がありません。