治験レーダーAI | ||
|---|---|---|
治験 NCT01162694（対象：2型糖尿病）は一時停止です。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
Comparing Internet Blood Glucose Monitoring System and Continuous Glucose Monitoring System 50
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 NCT01162694 は 介入研究 臨床試験 で、2型糖尿病 に関するものです。現在は 一時停止 で、2010年7月1日 から開始しています。50 名の参加者 の募集が計画されています。この試験は Endocrine Research Society によって主導され、該当なし に完了予定です。ClinicalTrials.gov からの最新更新日は 2014年9月11日 です。
概要
Management of type 2 diabetes is an ongoing challenge for patients and their doctors. In order to prevent short and long term complications, patients need to monitor and control their blood sugar levels. In addition, they may need to have an ongoing communication with their doctor in order to modify treatment. In this study the investigators wish to compare two systems of monitoring and communication of blood sugar l...もっと見る
詳細説明
Purpose: To compare the benefits of the Internet-based glucose monitoring system with the Continuous Glucose monitoring system in patients with type 2 diabetes mellitus.
Hypothesis:The investigators propose that the benefits from the Internet-based glucose monitoring system (IBGMS) will be comparable to the benefits of the Continuous Glucose monitoring system (CGMS) for patients with type 2 DM.
Justification: Half ...
もっと見る公式タイトル
Protocol: Comparing the Effect of Using an Internet-Based Glucose Monitoring System Versus the Continuous Glucose Monitoring System on HbA1c Levels in Type 2 DM
疾患名
2型糖尿病刊行物
この臨床試験について発表された科学記事と研究論文：その他の研究識別子
- IBGMS vs CGMS
NCT番号
開始日
2010-07
最終更新日
2014-09-11
目標参加者数
50
試験の種類
介入研究
治験の相・段階
該当なし
状況
一時停止
キーワード
Remote Blood Glucose Monitoring System,
Continuous Glucose Monitoring System,
Type 2 Diabetes
Continuous Glucose Monitoring System,
Type 2 Diabetes
主目的
支持療法
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 |
|---|---|
実薬対照薬Internet Intervention The subjects enrolled in the Internet Therapeutic Intervention arm receive standard care by testing their blood glucose at least 3 times daily and visit the endocrinologist every 3 months; however, they are also asked to upload their blood glucose readings online every 2 weeks for the health practitioner to view and comment upon. | Remote Blood Glucose Monitoring The subjects enrolled in the Internet Therapeutic Intervention arm receive standard care by testing their blood glucose at least 3 times daily and visit the endocrinologist every 3 months; however, they are also asked to upload their blood glucose readings online every 2 weeks for the health practitioner to view and comment upon. |
実薬対照薬Continuous Glucose Monitoring The use of CGMS (Sensor, receiver, transmitter) plus the uploading of results to the Internet-based software utility of CareLink Personal and generating reports that can be viewed and used at the patient's own preference. This group will send the uploaded data and receive feedback from their endocrinologist every 2 weeks. | 持続血糖モニタリング The use of CGMS (Sensor, receiver, transmitter) (Medtronic Diabetes) plus the uploading of results to the Internet-based software utility of CareLink Personal and generating reports that can be viewed and used at the patient's own preference. This group will not receive feedback or suggestion based on the uploaded glucose data. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
The primary endpoint is the A1c level or the change in A1c level | 6 Months |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
The secondary endpoint include severe hypoglycemia defined as requiring external aid (hospital or other). | 6 Months | |
A secondary endpoint includes adverse events such as unplanned hospitalizations for any cause that last more than 24 hours | 6 monthns |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
25 Years
対象性別
全て
- Type 2 diabetes patients being treated with insulin for at least 3 months
- HbA1c > 7%
- > 25 years of age
- Willingness to test blood glucose levels a minimum of 3 times daily
- Willingness to be trained on using the Continuous Glucose Monitoring System
- Willingness to be randomized
- Trained in self-blood glucose monitoring
- Internet Access on a Windows Personal Computer
- No prior use or training on CGMS in the past 6 months
- No prior use or training on IBGMS in the past 6 months
Patients who do not meet the above criteria or are not willing to participate will not be included in the study. Additional exclusion criteria include:
- Patient with medical conditions that may affect their study participation or results will be excluded.
- Patients with the potential to become pregnant
- Patients using medications known to influence control of diabetes (eg steroids systemic or inhaled)
- Liver disease (AST or ALT levels > 2.5 times the reference level)
- Renal insufficient with a serum creatinine level > 200 μmol/L
Endocrine Research Society責任者
Dr. Hugh Tildesley, 主任研究者, Clinical Professor, Endocrine Research Society
連絡先情報がありません。
1 1カ国の場所
British Columbia
St. Paul's Hospital, Vancouver, British Columbia, Canada