Qingdao: Insulin Pump Follow-Up Program
2019年4月19日 更新者：Medtronic Diabetes
Qingdao: Insulin Pump Follow-up Program
The purpose of the study is to observe/ collect clinical data, subject users' feedback, and device data to better understand the real-life usage and acceptance of the 722 Pump in type 1 diabetes subjects,<18 years of age, and the role of insulin pump therapy in Qingdao,China.
調査の概要
状態
終了しました
条件
詳細な説明
This is a prospective, multi-center, non-randomized and noninterventional post-market release study.
Subjects will participate in 2 phases with each phase requiring the subject to use the continuous subcutaneous insulin infusion (CSII) pump over the course of the study.
During the study, subjects and parent or legal guardian will be trained to wear the glucose sensor in the abdominal area for 3 days to transmit real-time (RT) data to the pump.
The duration of each study phase is approximately 6 months.
研究の種類
観察的
入学 (実際)
16
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Shandong
-
Qingdao、Shandong、中国
- The Affiliated Hospital of Qingdao University
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳未満 (子、大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
A total of approximately 100 subjects (age<18 years) will be enrolled by up to 10 investigational centers to complete 13 scheduled study visits in the study.
説明
Inclusion Criteria:
- Subject is age < 18 years at time of screening
- Subject has a clinical diagnosis of type 1 diabetes
- Subject is willing to perform required sensor calibrations
- Subject is willing to wear the Medtronic MiniMed Paradigm® REAL Time System continuously throughout the study
- Subject is a participant in the Qingdao project.
Exclusion Criteria:
- Subject is actively participating in an investigational study (drug or device) wherein he/she has received diabetes treatment from an investigational study drug or investigational study devices in the last 2 weeks
- Subject has known hypersensitivity to insulin or insulin infusion set(including tape)
Subject has used the insulin pump and/or real time CGM/sensor within 90 days before the screening visit for more than 10 days in the outpatient setting:
- For example, subjects who have used insulin pump and/or real time CGM/sensor in the inpatient setting will still be eligible for enrollment.
- For example, subjects who have used insulin pump and/or real time CGM/sensor for 8 days in the outpatient setting within 90 days before screening visit will still be eligible for enrollment.
- For example, subjects who have worn the insulin pump and/or real time CGM/sensor for 3 months in the outpatient setting a year before the screening visit will still be eligible for enrollment
- 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 anti-diabetic agents.
- Subject has any systemic disease or medical condition found on screening 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.
- Subject is being treated for hyperthyroidism at time of screening
- Subject has taken any oral, injectable, or IV steroids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV steroids during the course of the study
- Subject is currently abusing alcohol9. Any condition that either the Investigator believes would interfere with study participation or evaluation of results.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
|---|
|
Medtronic MiniMed Paradigm® REAL-Time System
Medtronic MiniMed Paradigm® REAL-Time System consisting of Paradigm 722 Insulin Pump (MMT-722), Medtronic MiniLink® REAL-Time Transmitter (MMT-7703) and Sof-Sensor® (MMT-7003) Glucose Sensor
|
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 |
|---|---|---|
|
Change in Glycosylated Hemoglobin (A1C)
時間枠：Change in A1C from baseline to end of study (1 year)
|
The change of A1C from baseline to end of study (1 year) will be presented
|
Change in A1C from baseline to end of study (1 year)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Average Glucose Values Based on Continuous Glucose Monitoring Data
時間枠：Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
|
The average glucose value of all available glucose value of each subject for each evaluation period is calculated, and we present the mean and std of the individual average glucose value for each evaluation period.
|
Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
|
|
Standard Deviation of Glucose Value Based on Continuous Glucose Monitoring Data
時間枠：Data is collected 7 days following the end of each period (At end of month 3, no glucose data is collected.).
|
The standard deviation of all available glucose value of each subject for each evaluation period is calculated, and then we present the mean and std of the individual standard deviation for each evaluation period.
|
Data is collected 7 days following the end of each period (At end of month 3, no glucose data is collected.).
|
|
Coefficient of Variation of Glucose Value Per Each Subject Based on Continuous Glucose Monitoring Data
時間枠：Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
|
The coefficient of variation of all available glucose value of each subject for each evaluation period is calculated, and then we present the mean and std of the individual coefficient of variation for each evaluation period.
|
Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
|
|
Mean Amplitude of Glycemic Excursion Based on Continuous Glucose Monitoring Data
時間枠：Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
|
Mean Amplitude of Glycemic Excursion (which is often used to characterize glycemic variability, to know the detail of calculation, please refer to "Glucose Variability, © 2013 by the American Diabetes Association." ) of each subject for each evaluation period is calculated, and then we present the mean and std of the individual Mean Amplitude of Glycemic Excursion for each evaluation period.
|
Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
|
|
Number of Events in the Hypoglycemic Range
時間枠：Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
|
Number of events in the hypoglycemic range (SG≤3.9mmol/L) of all available glucose value of each subject for each evaluation period is calculated, and then we present the mean and std of the individual number of events for each evaluation period.
|
Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
|
|
Number of Events in the Hyperglycemic Range
時間枠：Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
|
Number of Events in the Hyperglycemic Range (SG≥10.0
mmol/L) of all available glucose value of each subject for each evaluation period is calculated, and then we present the mean and std of the individual number of events for each evaluation period.
|
Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
|
|
Area Under Curve in the Hypoglycemic Range
時間枠：Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
|
Area under Curve in the hypoglycemic range (SG≤3.9mmol/L) of all available glucose value of each subject for each evaluation period is calculated, and then we present the mean and std of the individual Area under Curve for each evaluation period.
|
Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
|
|
Area Under Curve in the Hyperglycemic Range
時間枠：Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
|
Area under Curve in the hyperglycemic range (SG≥10.0
mmol/L) based on all available glucose value of each subject for each evaluation period is calculated, and then we present the mean and std of the individual Area under Curve for each evaluation period.
|
Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
|
|
Percentage of Time in the Hypoglycemic Range
時間枠：Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
|
Percentage of time in the hypoglycemic range (SG ≤ 3.9 mmol/L) of all available glucose value of each subject for each evaluation period is calculated, and then we present the mean and std of the individual percetage of time in that range for each evaluation period.
|
Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
|
|
Percentage of Time in the Hyperglycemic Range
時間枠：Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
|
Percentage of time in the hyperglycemic range (SG≥10.0
mmol/L) of all available glucose value of each subject for each evaluation period is calculated, and then we present the mean and std of the individual percentage of time in that range for each evaluation period.
|
Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Tang Li、The Affiliated Hospital of Qingdao University
- 主任研究者：chunbin Wang、Chinese People's Liberation Army 401 Hospital
- 主任研究者：Yamie Zhu、Qingdao Endocrine and Diabetes Hospital
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2015年4月1日
一次修了 (実際)
2016年9月1日
研究の完了 (実際)
2016年9月1日
試験登録日
最初に提出
2015年12月18日
QC基準を満たした最初の提出物
2016年1月12日
最初の投稿 (見積もり)
2016年1月14日
学習記録の更新
投稿された最後の更新 (実際)
2019年7月11日
QC基準を満たした最後の更新が送信されました
2019年4月19日
最終確認日
2019年4月1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。
1型糖尿病の臨床試験
-
Centre Hospitalier Universitaire, Amiens募集
-
Oxford Brookes UniversityUniversity of Oxford完了身体活動 | メンタルヘルス ウェルネス 1 | 認知機能1、社会 | Academic Attainment | Fitness Testingイギリス
-
Merck Sharp & Dohme LLC募集非小細胞肺がん | 固形腫瘍 | プログラム細胞死-1 (PD1、PD-1) | プログラム細胞死 1 リガンド 1(PDL1、PD-L1) | プログラム細胞死 1 リガンド 2 (PDL2、PD-L2)日本
-
CONRADNational Institute of Allergy and Infectious Diseases (NIAID); Eunice Kennedy Shriver National... と他の協力者完了
-
Alvotech Swiss AG完了
-
Calliditas Therapeutics ABEurofins Optimed; York Bioanalytical Solution完了