Evaluation of Basal Insulin Initialization and Titration in People With Type 2 Diabetes Wearing a Dexcom G6 Sensor
2026年6月26日 更新者：DexCom, Inc.
Evaluation of Basal Insulin Initialization and Titration in People With Type 2 Diabetes Wearing a Dexcom Sensor
To evaluate the feasibility of the DexBasal Study System
研究概览
详细说明
To evaluate the feasibility of the DexBasal Study System for recommending doses of basal insulin, embodied as a clinician facing Web portal.
研究类型
介入性
注册 (实际的)
45
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
California
-
San Diego、California、美国、92111
- San Diego Family Care (SDFC)
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria: Patients with a diagnosis of Type 2 diabetes (T2D) mellitus
- Ages equal or greater 18 years ("age" determined at the time of the Screening Visit)
- Bodyweight between 30-450 kg
- Comfortable with and willing to administer basal insulin injections, once a day, for approximately 75 consecutive days, and log daily injections in the Dexcom CGM mobile application.
- Willing to wear Dexcom CGM for duration of study
Exclusion Criteria:
- Recent severe hypoglycemia, complicated by seizure(s) or loss of consciousness, in the past 3 months
- Subjects with any contraindications for starting or continuing basal insulin therapy
- Glomerular filtration rate (eGFR) < 30 ml/min/1.73m2 (within 6 months of insertion) or on hemodialysis
- Introducing or increasing glucose lowering medications simultaneously
- Any condition that, in the opinion of the Investigator, would interfere with a subject's participation in the trial or pose excessive risk to subject and/or study staff
- For subjects of child-bearing potential: Pregnancy, demonstrated by a positive test no more than 72 hours prior to Clinic Visit 1
- Has used prandial insulin in the last 30 days.
- Anticipated addition of medications that could have significant impact on insulin sensitivity such as atypical antipsychotics.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：设备可行性
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：Dexbasal
Subjects initiating basal insulin therapy or on basal insulin therapy maintenance and benefit from transitioning to a study-specific type of basal insulin within 72 hours of Phase 1.
|
daily basal insulin dose
其他名称：
Dexcom Continuous Glucose Monitoring (CGM) Sensor
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Measurement of participant safety while using the DexBasal Study System
大体时间：Day 10 up to 8 weeks
|
Subject safety measured by the number of Severe Adverse Events (SAEs)
|
Day 10 up to 8 weeks
|
|
Measurement of system recommended dose
大体时间：Day 10 up to 8 weeks
|
System functionality measured by the generation of a recommended dose.
|
Day 10 up to 8 weeks
|
|
Frequency of Physician approval of Dexbasal Study system's daily dose recommendation
大体时间：Day 10 up to 8 weeks
|
System functionality measured by the physician review and physician approval of daily dose recommendations in Phase 2.
|
Day 10 up to 8 weeks
|
|
Subject reported insulin dose
大体时间：Day 10 up to 8 weeks
|
System functionality measured by the subject-reported basal insulin dose injections.
|
Day 10 up to 8 weeks
|
|
Evaluation of the CGM Metrics based on average glucose
大体时间：Baseline through end of study, an average of 96 days
|
-Measure of Average glucose (mg/dL)
|
Baseline through end of study, an average of 96 days
|
|
Evaluation of the CGM Metrics using coefficient variation (CV)
大体时间：Baseline through end of study, an average of 96 days
|
- Measure of CV (%)
|
Baseline through end of study, an average of 96 days
|
|
Evaluation of the CGM Metrics for time in range (TIR)
大体时间：Baseline through end of study, an average of 96 days
|
- Measure of TIR (70-180 mg/dL) (%)
|
Baseline through end of study, an average of 96 days
|
|
Evaluation of the CGM Metrics of time spent very low
大体时间：Baseline through end of study, an average of 96 days
|
- Measure of Time spent very low (<54 mg/dL) (%)
|
Baseline through end of study, an average of 96 days
|
|
Evaluation of the CGM Metrics of time spent low
大体时间：Baseline through end of study, an average of 96 days
|
- Measure of Time spent low (54-69 mg/dL) (%)
|
Baseline through end of study, an average of 96 days
|
|
Evaluation of the CGM Metrics of time spent below 70 mg/dL
大体时间：Baseline through end of study, an average of 96 days
|
- Measure of Time spent low (<70 mg/dL) (%)
|
Baseline through end of study, an average of 96 days
|
|
Evaluation of the CGM Metrics of time spent high
大体时间：Baseline through end of study, an average of 96 days
|
- Measure of Time spent high (>180 mg/dL) (%)
|
Baseline through end of study, an average of 96 days
|
|
Evaluation of the CGM Metrics of time spent very high
大体时间：Baseline through end of study, an average of 96 days
|
- Measure of Time spent very high (>250 mg/dL) (%)
|
Baseline through end of study, an average of 96 days
|
|
Measure of glycemic control
大体时间：Baseline through end of study, an average of 96 days
|
Fasting Glucose
|
Baseline through end of study, an average of 96 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Gain understanding and perspective from study subjects with questionnaires
大体时间：End of study, on average Day 96
|
- Diabetes Treatment and Satisfaction Questionnaire change measures
|
End of study, on average Day 96
|
|
Gain understanding and perspective from study subjects through status questionnaire
大体时间：Baseline
|
- Diabetes Treatment and Satisfaction Questionnaire status measures
|
Baseline
|
|
Gain understanding and perspective from study subjects through Relationship Scale
大体时间：Baseline through end of study, an average of 96 days
|
- Patient-Doctor Depth of Relationship Scale minimum score is zero, maximum score is 32.
Higher score means a better outcome.
|
Baseline through end of study, an average of 96 days
|
|
Gain understanding and perspective from study subjects through Satisfaction Survey
大体时间：Baseline through end of study, an average of 96 days
|
- Glucose Monitoring Satisfaction Survey
|
Baseline through end of study, an average of 96 days
|
|
Gain understanding and perspective from study subjects thru study specific items
大体时间：Baseline through end of study, an average of 96 days
|
- Study-specific items
|
Baseline through end of study, an average of 96 days
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2023年4月11日
初级完成 (实际的)
2026年1月16日
研究完成 (估计的)
2027年1月15日
研究注册日期
首次提交
2026年5月18日
首先提交符合 QC 标准的
2026年6月26日
首次发布 (实际的)
2026年7月2日
研究记录更新
最后更新发布 (实际的)
2026年7月2日
上次提交的符合 QC 标准的更新
2026年6月26日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.