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临床试验 NCT03365180 针对2型糖尿病目前已完成。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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Starter Kit Study in Insulin naïve Patients II期, III期 8
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临床试验NCT03365180旨在研究治疗，主要针对2型糖尿病。这是一项II期 III期 干预性研究试验，试验状态为已完成。试验开始于2018年1月3日，共计划招募8名患者。该研究由Signe Schmidt主导，已于2020年1月15日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2020年2月12日。
简要概括
The concept consists of an initial period (two weeks) of intensive data capture by use of continuous glucose monitoring (CGM) during basal insulin initiation, followed by a second period (variable duration) of basal insulin titration guided by self monitored blood glucose. Data captured during the first period are used as input to an algorithm that estimates the optimal daily dose for the individual patient. The esti...显示更多
官方标题
Starter Kit Study in Insulin naïve Patients With Type 2 Diabetes
疾病
2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
- StarterKit2017
NCT编号
实际开始日期
2018-01-03
最近更新发布
2020-02-12
预计完成日期
2020-01-15
计划入组人数
8
研究类型
干预性研究
试验分期 (阶段)
II期
III期
III期
试验状态
已完成
主要目的
治疗方法
分配方式
不适用
干预模型
单组试验
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性The Starter Kit Algorithm Basal insulin initiation and titration using the Starter Kit Algorithm at two weeks, followed by standard of care titration during the following the next 10 weeks (maximum), or until optimal daily dose is considered identified. | Starter Kit Algorithm Long acting insulin titration to target |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Accuracy of estimate 1 | Accuracy of the estimated optimal daily dose (calculated by the Starter Kit algorithm based on continuous glucose monitoring (CGM) data collected during day 1-14) compared with the observed optimal daily dose in percentage deviation.
In this context, optimal daily dose is the dose considered to keep fasting glucose levels below 6 mmol/L. | through study completion, 12 weeks |
Accuracy of estimate 2 | The number of estimated optimal daily doses by the Starter Kit Algorithm at two weeks that fall within a patient specific confidence interval.
The confidence interval is determined using the Starter Kit Algorithm at the end of study, one interval for each patient.
Upper boundary: the optimal daily dose estimated to bring lowest hour of CGM values within a day to 4.0 mmol/L Lower boundary: the optimal daily dose estimated to bring lowest hour of CGM values within a day to 6.0 mmol/L | through study completion, 12 weeks |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Accuracy of estimate 3 | Accuracy of the estimated optimal daily dose (calculated based on self-monitored blood glucose data collected during day 1-14) compared with the observed optimal daily dose. | through study completion, 12 weeks |
Number of patients in glucose target | Number of participants in target at end of study | through study completion, 12 weeks |
Algorithm deviations | Number of titration algorithm deviations due to risk of hypoglycemia (based on evaluation of CGM data) | 12 weeks (total duration of study) |
Quality of treatment 1 | Qualitative assessment by the investigator of participants who do not reach the observed optimal daily dose within 12 weeks: Frequency of participants who are in need of additional basal insulin to achieve the target blood glucose. | through study completion, 12 weeks |
Quality of treatment 2 | Qualitative assessment by the investigator of participants who do not reach the observed optimal daily dose within 12 weeks: Frequency of participants who are in need of additional drugs to achieve the target blood glucose. | through study completion, 12 weeks |
Number of self-monitored blood glucose values ≤3.9 mmol/L | Number of self-monitored blood glucose values ≤3.9 mmol/L | 12 weeks (total duration of study) |
Number of self-monitored blood glucose values ≤3.0 mmol/L | Number of self-monitored blood glucose values ≤3.0 mmol/L | 12 weeks (total duration of study) |
Severe hypoglycemia | Number of severe hypoglycemic events (defined as severe cognitive impairment requiring external assistance for recovery). | 12 weeks (total duration of study) |
Time spent in hypoglycemia | Time spent in hypoglycemia (\<3.9 mmol/L) assessed by CGM during the first four study days (days without insulin) and the last four study days (days with optimal daily insulin dose). | 8 days (first four and last four days of study) |
Time spent in hyperglycemia | Time spent in hyperglycemia (\>10 mmol/L) assessed by CGM during the first four study days (days without insulin) and the last four study days (days with optimal daily insulin dose). | 8 days (first four and last four days of study) |
Time spent in normoglycemia | Time spent in normoglycemia (3.9-10.0 mmol/L) assessed by CGM during the first four study days (days without insulin) and the last four study days (days with optimal daily insulin dose). | 8 days (first four and last four days of study) |
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
- Type 2 diabetes
- Age 18-75 years
- HbA1c 53-86 mmol/mol (7.0-10.0%)
- BMI 20-40 kg/m2
- Insulin-naïve
- Willingness to use CGM consistently during the study period and send/receive data and dose advice to/from HCP via a mobile phone
- Signed informed consent prior to any study procedures
- Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
- Active proliferative retinopathy
- Mean blood glucose > 15 mmol/l the week prior to screening
- Blood glucose > 20 mmol/l on the screening day
- Non-fasting ketones > 0,5 mmol/l on the screening day
- Use of sulfonylurea within 14 days prior to or during the study period
- Change in other antidiabetic medicine than basal insulin during the study period
- Use of corticosteroids within 30 days prior to or during the study period
- Marked change in lifestyle within 30 days prior to or during the study period as assessed by the investigator
- People with type 2 diabetes that suffer from conditions which make tight diabetes control undesirable, e.g. severe cardiovascular disease, according to the investigator
- Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
- Overall treatment
Signe Schmidt- Technical University of Denmark
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研究责任方
Signe Schmidt, 申办者-研究者, Principal Investigator, Hvidovre University Hospital
没有联系数据。
1 位于 1 个国家/地区的研究中心
Hvidovre University Hospital, Hvidovre, 2650, Denmark