Sensor Augmented Pump Therapy Versus Multiple Daily Injection Therapy
Sensor Augmented Pump Therapy Versus Multiple Daily Injection Therapy for Hospitalized Patients in China With Type 2 Diabetes; Time to Target
調査の概要
詳細な説明
Primary objective:
To compare the length of time to achieve target glucose range using Self-Monitoring Blood Glucose (SMBG), as reference method, with the 722 Paradigm Real-Time insulin pump versus MDI
Secondary Objectives:
To compare glycemic variability (using CGM as reference method) with the 722 Paradigm Real-Time insulin pump versus MDI
This is a prospective, randomized (open label), multi-center study. The clinical study staff will conduct screening tests according to inclusion/exclusion criteria in order to verify the subject's eligibility for the study.
Inpatient Period A patient is admitted into hospital for treatment of diabetes
Randomization
Subjects are randomized (at a 1:1 ratio) to group A or B in the study database. A total of 80 subjects will be randomized into 2 study groups:
- Group A will wear 722 Paradigm Real-Time System (treated with 24h per day insulin infusion)
- Group B will be on MDI and wear the CGMS-Gold (treated with 4 insulin injections).
It is anticipated that the total duration for the study will be within one year from site initiation to finalization of all data entry and monitoring.
Each subject will participate in the study approximately 2 weeks.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Beijing、中国
- Chinese PLA General Hospital
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Jilin
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Changchun、Jilin、中国
- The Second Hospital of Jilin University
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Subject is 18 to 65 years old at time of screening
- A clinical diagnosis of type 2 diabetes > 6 months prior to the screening as determined by the Investigator,
- Treating with insulin at least one injection per day prior to participate in the study
- Glycosylated hemoglobin (A1C) > 8% at screening
- Subject needs to be hospitalized to receive treatment for glucose management according to Endocrinologists' discretion
- Subject is willing to follow protocol and underdo all study procedures
- Subject is willing and able to provide informed written consent personally or by legal proxy
Exclusion Criteria:
- Subject has known hypersensitivity to insulin or insulin infusion set
- Subject has been treated with drugs with a known effect on BG within 8 weeks before enrollment other than diabetes medications such as insulin or oral agents.
- random blood glucose is above 33 mmol/L
- Subject is currently using real time CGM therapy prior to screening
- Subject is currently using insulin pump therapy prior to screening
- Female subject who is pregnant, or plans to become pregnant during the course of the study
- Patients who are critically ill that must go to intensive critical care unit per Investigator discretion
Subject has any systemic disease or medical condition found on the screening tests that may interfere with the safety of the patient and efficacy of the study treatment, in the opinion of the Investigator, may preclude him/her from participating in the study. The following includes, but not limited to, those conditions:
- Female subject has a positive serum pregnancy screening test
- Subject has visually impaired or disability limits the use of RT-CGM.
- Subject has any unresolved adverse skin condition in the area of sensor placement or device replacement (e.g., psoriasis, rash, Staphylococcus infection)
- Subject has disease with a known effect on BG such as Active Graves' disease
- Subject has a history of alcohol abuse
- Any other condition, which may not be suitable for the study at physician's discretion.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Pump
Paradigm 722 insulin pump used for insulin infusion and continuous glucose monitoring
|
722 Paradigm Real-Time System
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|
アクティブコンパレータ：MDI
Multiple daily insulin injections used for treatment
|
Device used to collect retrospective sensor data, blinded to the subjects, to compare to the treatment arm
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time to Target
時間枠：Up to 14 days in hospital
|
length of time to achieve target glucose range using Self-Monitoring Blood Glucose (SMBG), as reference method, with the 722 Paradigm Real-Time insulin pump versus Multiple Daily Injection
|
Up to 14 days in hospital
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Glycemic Variability
時間枠：Up to 14 days in hospital
|
Glycemic variability (mean amplitude glycemic excursion) using CGM as reference method
|
Up to 14 days in hospital
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。