治験レーダーAI | ||
|---|---|---|
治験 NCT05251116（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Study of an Interstitial Fluid Glucose Sensor 332
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 NCT05251116 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。2021年12月11日 に開始し、332 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、2022年8月15日 に完了しました。ClinicalTrials.gov からの最新更新日は 2023年8月4日 です。
概要
To characterize the System performance with respect to Yellow Springs Instrument (YSI) reference venous plasma measurements. Safety of the investigational device will be characterized by Adverse Device Effects and Serious Adverse Device Effects experienced by study participants.
詳細説明
Up to 200 adult and 250 pediatric (17 years of age or younger) subjects will be enrolled to obtain at least 200 evaluable subjects. At least four (4) subjects between the ages of 2 and 5 will be enrolled. Subjects will wear a total of two (2) sensors, one on the back of each upper arm.
Each subject will wear two sensors, from the same Sensor lot, one on the back of each upper arm. One or more unique sensor lots will...
もっと見る公式タイトル
Accuracy Study of an Interstitial Fluid Glucose Sensor
疾患名
糖尿病その他の研究識別子
- ADC-US-VAL-21206
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 |
|---|---|
その他only one Arm is included in this study This is a non-randomized, single arm study. All subjects will use the System. Results from the System will be compared to reference instrument. | FreeStyle Libre FreeStyle Libre 2 continuous Glucose Monitoring System |
主要評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
System Performance | System Performance will be evaluated against the reference system, Yellowstone Instrument (YSI) and against Capillary blood Glucose (BG). During several in clinic visits, plasma samples obtained from the subjects at various time intervals will be analyzed using the YSI. Results will be compared with results obtained from the System, to determine the system accuracy. Similarly, capillary Blood Glucose will be measured and compared with results obtained from the system. | 46 Days |
適格基準
対象年齢
小児, 成人, 高齢者
試験の最低年齢
2 Years
対象性別
全て
Subjects must meet all of the following inclusion criteria to be considered eligible for participation in the study:
- Subject must be at least 2 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 4 finger sticks per day while wearing the sensor in the study.
- Subject and/or guardian must be able to read and understand English.
- For subjects age between 2 and 5: willing to allow medical personnel to perform up to 16 capillary finger sticks to allow for capillary blood samples to be obtained per the study protocol.
- For subjects age 6 and older: willing to allow medical personnel to insert an IV catheter in the arm to allow for venous blood samples to be obtained per the study protocol.
- For subjects age 11 and older: subject is willing to have their blood sugar manipulated during one or more in-clinic sessions.
- 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.
- At the time of enrollment, subject must be available to participate in all study visits.
- Known insulin sensitivity factor (only applicable to subjects age 11 and older)
- Subjects aged 18 years and older must be willing and able to provide written signed and dated informed consent.
- Subjects aged 17 years and younger must have a parent, guardian or legally authorized representative willing and able to provide written informed consent.
- Subjects aged 7 - 17 years of age must be willing and able to provide written signed and dated informed assent.
Subjects must not meet exclusion criteria to be considered eligible for participation in the study. The subject will be excluded from the study if:
15. Subject has a history of hypoglycemia unawareness (only applicable to subjects age 11 and older).
16. Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
17. Subjects age 11 and older: Subject is known to be pregnant, attempting to conceive or is not willing and able to practice birth control during the study duration (applicable to only to female subjects age 11 and older).
18. Subjects age 10 and younger: Subject is known to be pregnant or becomes pregnant during the study (only applicable to female subjects age 10 years and younger)
19. 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.
20. Subject has had an episode of severe hypoglycemia requiring intervention from a health care professional (i.e. EMT assistance, emergency room visit, or hospital admission) within the last six (6) months (only applicable to subjects age 11 and older).
21. Subject has had an episode of diabetic ketoacidosis (DKA) within the last three (3) months (only applicable to subjects age 11 and older).
22. Subject is currently participating in another clinical trial.
23. Subject has donated blood within 112 days (3.7 months) prior to the beginning of the study activities.
24. For subjects age 6 and older: subject has a hemoglobin (Hb) level that is below the normal range (for reference the low end of the normal range for Hb for adult males is 14 g/dL and for adult females is 12 g/dL1; for pediatric males and pediatric females aged 6 - 12 years old it is 11.5 g/dL; for pediatric males aged 12 - 17 it is 13.0 g/dL; for pediatric females aged 12 - 17 it is 12.0 g/dL2).
25. Subject has a known concomitant medical condition which, in the opinion of the investigator, could present a risk to the safety or welfare of the subject or study staff.
26. Subject has X-ray, MRI, CT or diathermy 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.
27. Subject is unsuitable for participation due to any other cause as determined by the investigator.
15. Subject has a history of hypoglycemia unawareness (only applicable to subjects age 11 and older).
16. Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
17. Subjects age 11 and older: Subject is known to be pregnant, attempting to conceive or is not willing and able to practice birth control during the study duration (applicable to only to female subjects age 11 and older).
18. Subjects age 10 and younger: Subject is known to be pregnant or becomes pregnant during the study (only applicable to female subjects age 10 years and younger)
19. 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.
20. Subject has had an episode of severe hypoglycemia requiring intervention from a health care professional (i.e. EMT assistance, emergency room visit, or hospital admission) within the last six (6) months (only applicable to subjects age 11 and older).
21. Subject has had an episode of diabetic ketoacidosis (DKA) within the last three (3) months (only applicable to subjects age 11 and older).
22. Subject is currently participating in another clinical trial.
23. Subject has donated blood within 112 days (3.7 months) prior to the beginning of the study activities.
24. For subjects age 6 and older: subject has a hemoglobin (Hb) level that is below the normal range (for reference the low end of the normal range for Hb for adult males is 14 g/dL and for adult females is 12 g/dL1; for pediatric males and pediatric females aged 6 - 12 years old it is 11.5 g/dL; for pediatric males aged 12 - 17 it is 13.0 g/dL; for pediatric females aged 12 - 17 it is 12.0 g/dL2).
25. Subject has a known concomitant medical condition which, in the opinion of the investigator, could present a risk to the safety or welfare of the subject or study staff.
26. Subject has X-ray, MRI, CT or diathermy 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.
27. 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。
5 1カ国の場所
California
Sansum Diabetes Research Institute, Santa Barbara, California, 93105, United States
Georgia
Atlanta Diabetes Associates, Atlanta, Georgia, 30318, United States
Idaho
Rocky Mountain Diabetes & Osteoporosis Center, Idaho Falls, Idaho, 83404, United States
Texas
Diabetes and Glandular Disease Clinic, San Antonio, Texas, 78229, United States
Washington
Rainier Clinical Research, Renton, Washington, 98057, United States