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临床试验 NCT06453434 (DIASELF) 针对1型糖尿病目前尚未招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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Diabetes Self-management With Continuous Glucose Monitoring (DIASELF) 500 观察性
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临床试验NCT06453434 (DIASELF)是一项针对1型糖尿病的观察研究试验，当前状态为尚未招募。试验尚未开始，计划于2024年7月1日开始，预计招募500名患者。该研究由Nordsjaellands Hospital主导，计划于2026年8月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2024年6月11日。
简要概括
The overall goal of this observational study is to investigate the interaction between people with type 1 diabetes and continuous glucose monitoring (CGM) and the impact of this interaction on quality of life, particularly the level of diabetes distress, and glycaemic metrics.
Participants will:
- Visit the clinic twice with a 14-day interval
- Fill out a survey before the first and at the last visit
- Use CGM as u...
详细描述
A two-centre observational study conducted in Denmark, including adults with type 1 diabetes (n=500) on multiple daily injections already using FreeStyle Libre 2.
Upon recruitment, participants will complete a survey of 11 validated questionnaires, including T1-DDS-28. For 14 days, participants will continue regular CGM use, smart insulin pens will record real-time insulin dosage, and an activity sensor will monitor...
显示更多官方标题
The Impact of Continuous Glucose Monitoring Based Self-management on Patient-Reported Outcomes and Glycaemia in Type 1 Diabetes
疾病
1型糖尿病出版物
关于此临床试验发表的科学文章和研究论文：其他研究标识符
- DIASELF
- U1111-1306-6133
NCT编号
实际开始日期
2024-07-01
最近更新发布
2024-06-11
预计完成日期
2026-08
计划入组人数
500
研究类型
观察研究
试验状态
尚未招募
关键词
Continuous Glucose Monitoring
Self-management
Diabetes Technology
Type 1 Diabetes
Diabetes Distress
Patient-reported Outcomes
Self-management
Diabetes Technology
Type 1 Diabetes
Diabetes Distress
Patient-reported Outcomes
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Diabetes Distress | Type 1 Diabetes Distress Scale (T1-DDS-28)) Score. Likert scale. Score from 1 to 5. Higher scores indicate higher grade of diabetes distress. | At baseline and after 14 days. |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Time in range (TIR) | Time in range defined as the percentage of time the sensor glucose is 3.9-10.0 mmol/L (70-180 mg/dL) | 14 days |
Time in tight range (TIR) | The percentage of time the sensor glucose is 3.9-7.8 mmol/L (70-140 mg/dL) | 14 days |
Time below range level 1 (TBR1) | The percentage of time the sensor glucose is 3.0-3.9 mmol/L (54-70 mg/dL) | 14 days |
Time below range level 2 (TBR2) | The percentage of time the sensor glucose is \<3.0 mmol/L (\<54 mg/dL) | 14 days |
TBR1 night | TBR 3.0-3.9 from 0000h to 0559h, level 1 night | 14 days |
TBR1 day | TBR 3.0-3.9 from 0600h to 2359h, level 1 day | 14 days |
TBR2 night | TBR \<3.0 from 0000h to 0559h, level 2 night | 14 days |
TBR2 day | TBR \<3.0 from 0600h to 2359h, level 2 day | 14 days |
Time above range level 1 (TAR1) | The percentage of time the sensor glucose is 10.1-13.9 mmol/L (181-250 mg/dL) | 14 days |
Time above range level 2 (TAR2) | The percentage of time the sensor glucose is 13.9 mmol/L (\>250 mg/dL) | 14 days |
TAR1 night | TAR1 10.1-13.9 from 0000h to 0559h, level 1 night | 14 days |
TAR1 day | TAR1 10.1-13.9 from 0600h to 2359h, level 1 day | 14 days |
TAR2 night | TAR2 \>13.9 from 0000h to 0559h, level 1 night | 14 days |
TAR2 day | TAR2 \>13.9 from 0600h to 2359h, level 1 day | 14 days |
Coefficient of variation (CV) | Measure of glucose variability. Calculated as 100 x (SD divided by mean glucose) | 14 days |
Mean sensor glucose | Mean sensor glucose (mmol/L and mg/dL) | 14 days |
Standard deviation of mean glucose (SD) | Standard deviation of mean glucose (SD) (mmol/L and mg/dL) | 14 days |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- Age between 18 and 85 years.
- Diagnosed with T1D over one year ago.
- Actively using FreeStyle Libre 2 (>80% sensor activity).
- Used FreeStyle Libre 2 for over three months.
- Uses multiple daily insulin injections.
- Capable of providing written informed consent.
- Willing and able to complete study procedures, including using smart caps or pens and completing questionnaires at the investigator's discretion.
- History of allergic reactions to materials or adhesives used in CGM devices.
- Presence of severe cognitive or psychiatric conditions that could hinder the effective use of CGM or smart caps or pens - at the investigator's discretion.
- Current use of steroids unless part of a chronic therapy plan.
- Daily consumption of vitamin C ≥ 500 mg.
Nordsjaellands HospitalSteno Diabetes Center Copenhagen研究中心联系人
联系人: Mette J Nitschke, PhD Student, +45 41 24 72 16, [email protected]
联系人: Ulrik Pedersen-Bjergaard, Professor, [email protected]
2 位于 1 个国家/地区的研究中心
Capital Region
Steno Diabetes Center Copenhagen, Herlev, Capital Region, 2730, Denmark
Kirsten Nørgaard, Professor, 联系人, +45 27 13 10 11, [email protected]
Kirsten Nørgaard, Professor, 主要研究者
Copenhagen University Hospital, North Zealand - Hilleroed, Hillerød, Capital Region, 3400, Denmark
Mette J Nitschke, PhD student, 联系人, +45 41 24 72 16, [email protected]
Mette J Nitschke, PhD student, 分研究者
Ulrik Pedersen-Bjergaard, Professor, 主要研究者