治験レーダーAI | ||
|---|---|---|
治験 NCT03141892（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
検索に戻る
アボットFreeStyle Libre Flash Glucose Monitoring System Accuracy Study 50 検証的試験 無作為化 多施設共同
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 NCT03141892 は 観察研究 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。2017年4月13日 に開始し、50 名の参加者 が参加しました。この試験は アボット によって主導され、2017年5月30日 に完了しました。ClinicalTrials.gov からの最新更新日は 2017年7月11日 です。
概要
This is a pivotal, non-randomized, single arm, multi-center, prospective, non-significant risk study to evaluate the FreeStyle Libre Flash Glucose Monitoring System.
詳細説明
Up to 60 subjects will be enrolled at up to six clinical research sites in the United States. Subjects will wear two Sensors of Three unique sensor lots. Each Sensor will have a paired Reader that will be given to the subject. All Readers will be masked during the study (i.e. subjects will not be able to view glucose results obtained from the Sensor on the Reader screen).
Subjects will be asked to perform at least 8...
もっと見る公式タイトル
FreeStyle Libre Flash Glucose Monitoring System Accuracy Study
疾患名
糖尿病その他の研究識別子
- ADC-US-VAL-17164
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
Diabetes Mellitus, Type 1 and Type 2 Subjects will wear the FreeStyle Libre Flash Glucose Monitoring System and will receive no treatment except for safety purposes. | FreeStyle Libre Flash Glucose Monitoring System Blood Glucose Monitoring |
主要評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
System Performance | System performance will be characterized with respect to YSI reference venous plasma sample measurements. | Approximately 32 hours |
System related adverse device effects and serious adverse effects | System will be characterized by Adverse Device Effects and Serious Adverse Device Effects experienced by study participants. | Up to 42 days |
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
- Subject must be at least 18 years of age.
- Subject must have type 1 or type 2 diabetes.
- Subject must require insulin therapy through an insulin pump and/or multiple daily insulin injections (at least 3 injections daily).
- Willing to perform a minimum of 8 finger sticks per day during the study.
- Subject must be willing to fast four individual times prior to in-clinic visits, each fast lasting a minimum of eight hours.
- Subject must be able to read and understand English.
- In the investigator's opinion, the subject must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol.
- Subject must be available to participate in all study visits.
- Subject must be willing and able to provide written signed and dated informed consent.
- Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
- Subject is pregnant, attempting to conceive or not willing and able to practice birth control during the study duration (applicable to female subjects only).
- Subject has extensive skin changes/diseases at the proposed application sites that could interfere with device placement or the accuracy of interstitial glucose measurements. Such conditions include, but are not limited to extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, dermatitis herpetiformis, skin lesions, redness, infection or edema.
- Subject currently is participating in another clinical trial.
- Subject has donated blood within 112 days (3.7 months) prior to the beginning of the study activities.
- Subject is anemic.
- Subject has concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff. Such conditions include but are not limited to:
- History of HIV, Hepatitis B or C
- Subject has X-ray, MRI or CT appointment scheduled during the period of study participation, and the appointment cannot be rescheduled for a time before study participation starts or after study participation ends.
- Subject is unsuitable for participation due to any other cause as determined by the Investigator.
アボット連絡先情報がありません。
4 1カ国の場所
California
William Sansum Diabetes Center, Santa Barbara, California, 93105, United States
Diablo Clinical Research, Walnut Creek, California, 94598, United States
Idaho
Rocky Mountain Diabetes & Osteoporosis Center, Idaho Falls, Idaho, 83404, United States
Washington
Rainier Clinical Research Center, Renton, Washington, 98057, United States