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正在招募不适用编号 NCT07144696

Study on the Improvement of Metabolic Indicators in Type 1 Diabetes Patients

报名条件(概要)

  • 年龄:18 Years – 不限
  • 性别:不限
  • 健康志愿者:不接受

完整入排标准请以官方页面为准。

开展国家/地区

China

药品与企业信息

structured education and regular follow-up行为干预

Regularly carry out structured diabetes courses for patients with type 1 diabetes and offline teaching at Peking University First Hospital. On the basis of structured courses, regular outpatient follow-up visits will be conducted for patients, with on-site visits conducted at the Endocrinology Clinic of Peking University First Hospital. The usual visit period is once every 1-3 months, and the specific follow-up time nodes will be determined by medical staff based on the patient\'s condition. Each visit will last 1-3 hours, and each subject is expected to be followed up for 1 year. During each visit, collect the medical history and some personal information of the subjects, complete the routine physical examination, draw blood to test diabetes related indicators (including the determination of fasting

研发企业

Peking University First Hospital研究机构/其他

试验官方登记的主要申办方;研究机构申办时会显示相应机构名称。

生产企业

公开药品批准资料或正式说明书暂未提供明确的生产企业信息。

研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业;生产企业仅取自美国上市原研药说明书所列企业(不含仿制药),不作推测;仅在其他国家上市的药品暂无法显示。

研究简介(原文)

In this study, type 1 diabetes patients from the outpatient department of Peking University First Hospital were selected as the research objects. The investigators plan to recruit 150 participants. Using the course and teaching plan of \"Take Control of My Life - Structured Education for Type 1 diabetes\" issued by the China Type 1 diabetes Alliance, offline teaching is carried out regularly for type 1 diabetes patients, aiming to improve participants' knowledge and skills of disease self-management and improve participants' self-management behavior. The course content includes diabetes diet, exercise, blood glucose monitoring, insulin injection, complication prevention, psychological adjustment, etc. The training will take place at Peking University First Hospital. On the basis of structured courses, regular outpatient follow-up will be further carried out for patients to standardize their treatment behavior, improve their blood sugar compliance rate and delay the occurrence and development of diabetes complications. The subject visit is conducted on-site at the Endocrinology Clinic of Peking University First Hospital. The usual visit period is once every 1-3 months, and the specific follow-up time is determined by medical staff based on the subject\'s condition. Each visit lasts 1-3 hours, and each subject is expected to be followed up for 1 year. During each visit, collect the medical history and some personal information of the subjects, complete the routine physical examination, draw blood to test diabetes related indicators (including the determination of fasting and postprandial blood glucose, C-peptide, glycosylated hemoglobin, islet autoantibodies, blood lipids, liver and kidney functions), and screen diabetes complications. At the time of enrollment and after 1 year of follow-up, diabetes related questionnaires mainly related to diabetes self-management behavior and psychological emotions.

适应症

Type 1 Diabetes Mellitus

主动联系研究团队

总联系人(申办方/研究总部)

中国/港澳台研究中心

问自己是否符合条件、如何预筛

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英文版(发给研究团队)

Dear Study Team,

I am a patient in China and I am interested in participating in your clinical trial:

Study Title: Study on the Improvement of Metabolic Indicators in Type 1 Diabetes Patients
ClinicalTrials.gov Identifier: NCT07144696
Sponsor: Peking University First Hospital
Investigational product: structured education and regular follow-up

About me:
- Age: (please fill in)
- Sex: (please fill in)
- Confirmed diagnosis and stage: (please fill in)
- Biomarkers / genetic testing: not available
- Prior and current treatments: (please fill in)
- Performance status (ECOG): not assessed
- Current location: China
- Travel ability: (please fill in)

Could you please let me know:
1. Whether I might be eligible for this study;
2. Which site would be closest and most practical for me, and whether remote pre-screening is possible;
3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening.

I can provide English translations of my medical records. Thank you very much for your time and help.

Kind regards,
(your name)
(your email / phone with country code)

中文对照(供您核对)

尊敬的研究团队:

我是一位来自中国的患者,希望咨询参加以下临床试验的可能:

研究名称:Study on the Improvement of Metabolic Indicators in Type 1 Diabetes Patients
试验编号:NCT07144696
申办方:Peking University First Hospital
研究药物:structured education and regular follow-up

我的基本情况:
- 年龄:(请填写)
- 性别:(请填写)
- 确诊疾病与分期:(请填写)
- 基因/标志物检测:暂无
- 既往及当前治疗:(请填写)
- 体能状态(ECOG):未评估
- 目前所在城市:中国
- 可前往范围:(请填写)

想请教三个问题:
1. 我是否可能符合本研究的入组标准?
2. 哪个中心对我最方便可行?能否远程预筛?
3. 预筛需要准备哪些资料(病历、病理、影像、近期化验)?

我可以提供英文翻译版病历。感谢您的时间与帮助。

顺祝安康
(您的姓名)
(您的邮箱/带国际区号的电话)
用邮件客户端发送给 13811135033@163.com

提示:请与主治医生一起发信——由医生署名的申请,回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复,两周无回音可礼貌追问一次。

下一步怎么做?

  1. 把本页信息带给您的主治医生,评估是否适合参加。
  2. 点击下方按钮打开官方注册页,查看研究中心联系方式。
  3. 直接联系研究团队咨询报名事宜(通常有中文同声翻译服务可协助沟通)。
在 ClinicalTrials.gov 查看官方页面