Evaluation of Basal Insulin Initialization and Titration in People With Type 2 Diabetes Wearing a Dexcom Sensor
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- DexCom, Inc.
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Measurement of participant safety while using the DexBasal Study System
研究概览
简要总结
To evaluate the feasibility of the DexBasal Study System
详细描述
To evaluate the feasibility of the DexBasal Study System for recommending doses of basal insulin, embodied as a clinician facing Web portal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Dexcom Continuous Glucose Monitoring (CGM) (Device)
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.
干预措施: Basal insulin (Drug)
结局指标
主要结局
Measurement of participant safety while using the DexBasal Study System
时间窗: Day 10 up to 8 weeks
Subject safety measured by the number of Severe Adverse Events (SAEs)
Measurement of system recommended dose
时间窗: Day 10 up to 8 weeks
System functionality measured by the generation of a recommended dose.
Frequency of Physician approval of Dexbasal Study system's daily dose recommendation
时间窗: Day 10 up to 8 weeks
System functionality measured by the physician review and physician approval of daily dose recommendations in Phase 2.
Subject reported insulin dose
时间窗: Day 10 up to 8 weeks
System functionality measured by the subject-reported basal insulin dose injections.
Evaluation of the CGM Metrics based on average glucose
时间窗: Baseline through end of study, an average of 96 days
-Measure of Average glucose (mg/dL)
Evaluation of the CGM Metrics using coefficient variation (CV)
时间窗: Baseline through end of study, an average of 96 days
\- Measure of CV (%)
Evaluation of the CGM Metrics for time in range (TIR)
时间窗: Baseline through end of study, an average of 96 days
\- Measure of TIR (70-180 mg/dL) (%)
Evaluation of the CGM Metrics of time spent very low
时间窗: Baseline through end of study, an average of 96 days
\- Measure of Time spent very low (\<54 mg/dL) (%)
Evaluation of the CGM Metrics of time spent low
时间窗: Baseline through end of study, an average of 96 days
\- Measure of Time spent low (54-69 mg/dL) (%)
Evaluation of the CGM Metrics of time spent below 70 mg/dL
时间窗: Baseline through end of study, an average of 96 days
\- Measure of Time spent low (\<70 mg/dL) (%)
Evaluation of the CGM Metrics of time spent high
时间窗: Baseline through end of study, an average of 96 days
\- Measure of Time spent high (\>180 mg/dL) (%)
Evaluation of the CGM Metrics of time spent very high
时间窗: Baseline through end of study, an average of 96 days
\- Measure of Time spent very high (\>250 mg/dL) (%)
Measure of glycemic control
时间窗: Baseline through end of study, an average of 96 days
Fasting Glucose
次要结局
- Gain understanding and perspective from study subjects with questionnaires(End of study, on average Day 96)
- Gain understanding and perspective from study subjects through status questionnaire(Baseline)
- Gain understanding and perspective from study subjects through Relationship Scale(Baseline through end of study, an average of 96 days)
- Gain understanding and perspective from study subjects through Satisfaction Survey(Baseline through end of study, an average of 96 days)
- Gain understanding and perspective from study subjects thru study specific items(Baseline through end of study, an average of 96 days)