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治験 NCT03369899（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。 | ||
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アボットFreeStyle Libre Flash Glucose Monitoring System in Pediatric Populations 72 無作為化 多施設共同 小児
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 NCT03369899 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12月11日 に開始し、72 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、2018年5月23日 に完了しました。ClinicalTrials.gov からの最新更新日は 2018年7月30日 です。
概要
This study is a non-randomized, single-arm, multi-center study that is designed to evaluate the safety and effectiveness of the FreeStyle Libre Flash Glucose Monitoring Systems in pediatric populations.
詳細説明
Up to 100 subjects will be enrolled at up to six (6) clinical research sites in the United States. Subjects will wear two Sensors. 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 4 capillary Blood Glucose...もっと見る
公式タイトル
Effectiveness and Safety Study of the FreeStyle Libre Flash Glucose Monitoring System in Pediatric Populations
疾患名
糖尿病その他の研究識別子
- ADC-US-VAL-17167
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
該当なし | FreeStyle Libre Flash Glucose Monitoring System Subjects will wear the FreeStyle Libre Flash Glucose Monitoring System and will receive no treatment except for safety purposes. |
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 for subjects aged 6 and older. Capillary blood glucose (BG) reference will be used for subjects aged less than 6 years of age.
For subjects age 6 years and older, point accuracy of the system will be evaluated as the proportion of System readings that are within ±20% of the YSI reference value for YSI glucose levels ≥ 80 mg/dL and within ±20 mg/dL for YSI glucose levels \<80 mg/dL. For subjects of age less than 6 years, ages 4 and older the system will be evaluated as the proportion of System readings that are within ±20% of the BG reference value for BG glucose levels ≥ 80 mg/dL and within ±20 mg/dL for BG glucose levels \<80 mg/dL. | Up to 14 days |
System Related adverse device effects | System will be characterized by Adverse Device Effects and Serious Adverse Device Effects experienced by study participants. | up to 45 days |
適格基準
対象年齢
小児
試験の最低年齢
4 Years
対象性別
全て
- Subject must be at least 4 years of age.
- Subject must have a diagnosis of type 1 or type 2 diabetes mellitus
- Subject must require insulin therapy through an insulin pump and/or multiple daily insulin injections (at least 3 injections daily).
- Subject must be currently performing at least four (4) capillary blood glucose tests per day.
- Subject is willing to perform a minimum of 4 finger sticks per day during the study.
- If 6 year of age or older and weighing at least 19 kg (41.8 lbs.), willing to allow medical personnel to insert at IV catheter in the arm to allow for venous blood samples to be obtained per the study protocol
- Subject and/or guardian 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 assent (subjects aged 13 to 17 only).
- Subject's parent, guardian or legally authorized representative must be willing and able to provide written informed consent.
- Subject is 18 years of age or older.
- Subject is 6 years or older and weighs less than 19 kg (subjects unable to complete 4 hours of YSI testing).
- Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
- Subject is known to be pregnant or becomes pregnant during the study (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 is currently participating in another clinical trial.
- Subject has had significant blood loss within 112 days (3.7 months) prior to the beginning of the study activities subjects.
- Subject is anemic (only applicable to subjects age 6 or older and weighing at least 19 kg) defined as hemoglobin levels below 11.5 g/dL for subjects aged 6-11 years old, less than 12.0 g/dL for subjects aged 12-15 years old, less than 12.0 g/dL for females aged 15-17 and less than 13.0 g/dL for males aged 15-171, or as determined by investigator.
- 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。
1 1カ国の場所
California
Sansum Diabetes Research Institute, Santa Barbara, California, 93105, United States