治験レーダーAI | ||
|---|---|---|
治験 NCT04964752（対象：糖尿病）は状況不明です。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
A Study of the Continuous Glucose Monitoring System for Home Use in Patients With Diabetes 144
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 NCT04964752 は 介入研究 臨床試験 で、糖尿病 に関するものです。現在は 状況不明 で、2021年7月30日 から開始しています。144 名の参加者 の募集が計画されています。この試験は Lee's Pharmaceutical Limited によって主導され、2022年4月30日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2021年7月16日 です。
概要
Subjects in the upper arm group will have a sensor of the CGM System inserted on each arm (left and right upper arm). Subjects in the abdomen group will have 2 sensors inserted, one on each side of the abdomen (left and right abdomen) The sensors will be placed for 29 days. After sensor insertion, the CGM system should be calibrated with capillary blood glucose readings from a self-monitoring blood glucose meter。
公式タイトル
Effectiveness and Safety Study of the Continuous Glucose Monitoring System for Home Use (Including In-clinic Sessions) in Patients With Diabetes
疾患名
糖尿病その他の研究識別子
- PL-CGM-202006
主目的
その他
割付方法
無作為化
介入モデル
並行割当
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the upper arm group on Day 2 The upper arm group to perform Visit 3 venous blood glucose measurement on Day 2. | continuous glucose-monitoring Continuous glucose-monitoring device indicated for continually recording interstitial fluid glucose levels in patients with diabetes. |
その他the upper arm group on Day 15±1 day The upper arm group to perform Visit 3 venous blood glucose measurement on Day 15±1 day. | continuous glucose-monitoring Continuous glucose-monitoring device indicated for continually recording interstitial fluid glucose levels in patients with diabetes. |
その他the upper arm group on Day 29±1 day The upper arm group to perform Visit 3 venous blood glucose measurement on Day 29±1 day. | continuous glucose-monitoring Continuous glucose-monitoring device indicated for continually recording interstitial fluid glucose levels in patients with diabetes. |
その他the abdomen group on Day 2 The abdomen group to perform Visit 3 venous blood glucose measurement on Day 2. | continuous glucose-monitoring Continuous glucose-monitoring device indicated for continually recording interstitial fluid glucose levels in patients with diabetes. |
その他the abdomen group on Day 15±1 The abdomen group to perform Visit 3 venous blood glucose measurement on Day 15±1. | continuous glucose-monitoring Continuous glucose-monitoring device indicated for continually recording interstitial fluid glucose levels in patients with diabetes. |
その他the abdomen group on Day 29±1 The abdomen group to perform Visit 3 venous blood glucose measurement on Day 29±1. | continuous glucose-monitoring Continuous glucose-monitoring device indicated for continually recording interstitial fluid glucose levels in patients with diabetes. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
%20/20 agreement between the test device readings and the EKF readings: %20/20 = A + B | A = the proportion of the CGM system values that were within ±20% of paired EKF values \>4.4mmol/L (\>80 mg/dL) B = the proportion of the CGM system values that were within ±1.1mmol/L (20mg/dL) of paired EKF values ≤4.4mmol/L (≤80mg/dL) | up to 29 days |
Proportion of readings in Region A + Region B of Clarke Error Grid | Analyze the proportion of readings in each region (Region A, B, C D and E). Readings in Region A are clinically accurate, while readings in Region B are of clinically acceptable accuracy. Readings in C, D and E are inaccurate to various degrees. | up to 29 days |
Proportion of readings in Region A + Region B of Consensus Error Grid | Analyze the proportion of readings in Region A and Region B. | up to 29 days |
the percentage of MARD (Mean Absolute Relative Difference) | Analyze the proportion of readings in MARD \<18% (95%CI\<20%). | up to 29 days |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Alarm success rate1 | Hypoglycemia alarm success rate and failure rate (sensitivity) | up to 29 days |
Alarm success rate2 | Hypoglycemia detection rate and missed detection rate (specificity) | up to 29 days |
Alarm success rate 3 | Hyperglycemia alarm success rate and failure rate | up to 29 days |
Alarm success rate 4 | Hyperglycemia detection rate and missed detection rate | up to 29 days |
Sensor Stability | Compare the accuracy of the sensor between Day 2(22h\~48h after insertion), Day 15±1day, Day 29±1day to evaluate sensor. | up to 29 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
- Type 1 or 2 diabetes mellitus
- Male or female age ≥ 18 years old and ≤ 70 years old
- Willingness to adopt measures to prevent water coming into contact with the device sensor (e.g. abstain from swimming, sauna, avoid hitting the sensor with direct jets of water)
- Ability to communicate with the investigators, able to operate medical device after training and comply with the testing procedures outlined in this protocol (including, but not limited to, willing to wear the continuous glucose monitor and testing capillary blood glucose)
- Subjects who show understanding of the study procedures and willing to sign a written informed consent form.
- Hospitalization due to diabetic ketoacidosis or severe hypoglycemia, within 3 months prior to screening
- HbA1c >13% or urine ketone 3+
- Use of pacemaker
- Body Mass Index (BMI) ≤18.0kg/m2
- Extensive skin changes/diseases that preclude wearing the required number of devices on normal skin at the proposed application sites, i.e. upper arm or abdomen (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis)
- Any psychiatric disease such as depression or anxiety
- Any severe hepatic, renal, cardiac, cerebral, respiratory or neurological diseases (e.g. serum ALT, AST, Creatinine level ≥3 times the upper limit of normal)
- Has a MRI scan, CT scan or other procedure requiring the subject be under strong magnetic or electromagnetic environment, scheduled during the proposed study participation
- Blood loss >400ml in the past 3 months (including blood donation)
- Have a known allergy to medical-grade adhesives, or known hypersensitivity to any of the products used in the study
- Difficulty in sampling venous blood or cannot tolerate venipuncture
- Participated in other investigational studies in the past 3 months
- Currently pregnant or lactating women, or positive pregnancy test
- Any condition that, in the opinion of the investigator, renders the subject not suitable for the study.
Lee's Pharmaceutical Limited- Powder (Guangzhou) Pharmaceuticals Limited
- Powder Pharmaceuticals (HK) Co., Ltd
試験中央連絡先
連絡先: Elaine Chow, Prof., (852) 3505 1642, [email protected]
位置情報がありません。