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FSL2 Post Approval Study for Pediatric and Young Adults Patients 550 無作為化 多施設共同 小児

募集中
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治験番号 NCT04959552 は 観察研究 臨床試験 で、糖尿病 に関するものです。現在は 募集中 で、2021年6月1日 から開始しています。550 名の参加者 の募集が計画されています。この試験は アボット によって主導され、2025年12月30日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年1月16日 です。
概要
This is a prospective, multi-center, non-randomized, single-arm study intended to characterize the safety of the FreeStyle Libre 2 Flash Glucose Monitoring System when used to manage diabetes in pediatric and young adult patient populations.
詳細説明
Approximately 550 pediatric and young adult subjects aged 4-30 years with type 1 or type 2 diabetes, who require daily blood glucose monitoring to manage their diabetes will be enrolled in the study. Subjects and/or their caregivers will utilize he FreeStyle Libre 2 Flash Glucose Monitoring System for managing diabetes for 6 months. Subjects and/or their caregivers will maintain a diary/log book of Adverse Events exp...もっと見る
公式タイトル

FreeStyle Libre 2 Flash Glucose Monitoring System Intervention Phase Study- FreeStyle Libre 2

疾患名
糖尿病
その他の研究識別子
  • ADC-US-PMS-20196
NCT番号
NCT04959552
開始日
2021-06-01
最終更新日
2025-01-16
終了予定日
2025-12-30
目標参加者数
550
試験の種類
観察研究
状況
募集中
群（アーム）／介入
参加グループ/群介入/治療法
該当なし
FreeStyle Libre 2
The FreeStyle Libre 2 Flash Glucose Monitoring
主要評価項目
評価指標指標の説明時間枠
Characterize the safety of the FreeStyle Libre 2 Flash Glucose Monitoring System when used to manage diabetes in pediatric and young adult patient populations
Incidence rate of severe hypoglycemic occurrences requiring health care professional (HCP) intervention including EMT assistance, hospital/clinic visit and/or hospitalization and moderate hypoglycemia in which the patient required the assistance of another person (e.g. as a result of confusion, coma, or seizure) during the study will be collected. The incidence rate of severe hypoglycemia associated with FSL2 use from this study will be compared with the incidence rate observed from self-monitoring blood glucose (SMBG) use observed during the prior 6 months.
Six Months
参加アシスタント
適格基準

対象年齢
小児, 成人
試験の最低年齢
4 Years
対象性別
全て
  1. Subject must be 4 - 30 years of age.
  2. Subject must have a diagnosis of type 1 or type 2 diabetes mellitus for at least 3 months prior to enrollment.
  3. Subject is currently using Self Monitoring of Blood Glucose (SMBG) for managing their diabetes.
  4. Subject has completed participation in clinical study ADC-US-PMS-20194 or has at least six (6) months of medical history hypoglycemia or hyperglycemia requiring healthcare professional intervention.
  5. Subject and/or caregiver must be able to read and understand English.
  6. In the investigator's opinion, the subject and/or caregiver 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.
  7. Subject and/or parent or guardian must be willing and able to provide written signed and dated informed consent and assent when appropriate.

  1. Subject has previously used a continuous glucose monitoring system to manage their diabetes within the last six (6) months.
  2. Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
  3. Subject is known to be pregnant or is attempting to become pregnant at the time of enrollment.
  4. Subject is on dialysis at the time of enrollment.
  5. 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.
  6. Subject currently is participating in another clinical trial.
  7. Subject is unsuitable for participation due to any other cause as determined by the Investigator.
Abbott Diabetes Care logoアボット
試験中央連絡先
連絡先: Mohamed Nada, PhD, 510-749-5416, [email protected]
3 1カ国の場所

Connecticut

Yale Pediatric Endocrinology Clinic, New Haven, Connecticut, 06511, United States
Stuart Weinzimer, MD, 連絡先
募集中

Missouri

The Children's Mercy Hospital, Kansas City, Missouri, 64108, United States
Mark Clements, MD, 連絡先
募集中

Nevada

The DOCS, Las Vegas, Nevada, 89113, United States
Asheesh Devan, MD, 連絡先
募集中