Starting Technology in At Risk Type 1 Diabetes (STAR-T1D) Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 5
- 主要终点
- Proportion of retention among participants randomized to the Intervention Group
研究概览
简要总结
Diabetes technology has revolutionized T1D management, disparities in technology access are evident among racial-ethnic minorities, patients with lower socioeconomic status and those with poorly controlled T1D (A1c>8.5%). In order to examine whether diabetes technology can reduce diabetes care burdens and enhance outcomes among some of highest need patients, diabetes technology clinical trials must be expanded beyond the very select populations included in studies thus far (ie., mostly White, higher SES). Therefore, the investigators propose to perform a pilot RCT of hybrid closed-loop insulin pump therapy (HCL) in 40 diverse adult patients with poorly controlled T1D (HbA1c >8.5%) from the largest academic and safety net health systems in the Los Angeles region to determine the feasibility of a RCT in this population and identify facilitators and barriers of effective use of closed loop insulin pump therapy in patients with poorly controlled T1D.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Type 1 Diabetes
- •A1c >8.5%
- •Not insulin pump user
- •Primary language of English or Spanish
- •Have medical insurance coverage
排除标准
- •No measured A1c in the past year
- •Have comorbidities that can result in inaccurate hemoglobin A1c
- •Have cognitive, physical or mental impairment precluding diabetes technology use
- •Limited life expectancy (<1 year)
- •Pregnancy
研究组 & 干预措施
Hybrid Closed Loop Insulin Pump System
Participants will meet 1:1 with our CDE for at least 6 sessions over 6 weeks. Sessions will cover self-management basics, carb counting, CGM interpretation, hypoglycemia and hyperglycemia management and troubleshooting device issues. The investigators will follow up with participants in 24 and 72 hours after CGM and insulin pump initiation, respectively, to answer any device related questions that may arise in between sessions.
Participants will follow up at intervals of 1-4 weeks throughout the study. During visits, the investigators will assess for adherence and adverse effects and evaluate device and safety issues associated with pump settings in the HCL arm. The investigators will repeat A1c at 12 weeks and 24 weeks and administer follow up questionnaires at 12 and 24 weeks.
干预措施: Hybrid Closed Loop Insulin Pump System (Device)
Control
Participants in the control arm will receive diabetes education at a similar frequency as the intervention group. Diabetes education for the control group will be a combination of in-person visits with the CDE and telephone brief diabetes education sessions.
Participants will follow up at intervals of 1-4 weeks throughout the study. During visits, the investigators will assess for adherence and adverse effects. The investigators will repeat A1c at 12 weeks and 24 weeks and administer follow up questionnaires at 12 and 24 weeks.
结局指标
主要结局
Proportion of retention among participants randomized to the Intervention Group
时间窗: 6 months
Retention among participants receiving allocated intervention after being randomized and discontinued intervention among randomized.
Proportion of screened participants that are eligible
时间窗: 6 months
Eligible among screened, enrolled among eligible, excluded among screened (and why) based on screening, recruitment and enrollment data.
Proportion of enrolled participants that are randomized
时间窗: 6 months
Randomized among enrolled, and receiving allocated intervention among randomized.
Proportion of average time delay to enrollment
时间窗: 6 months
Average time delay from screening to enrollment.
Number of participants who adhere to assigned treatment
时间窗: 6 months
Treatment-specific adherence, Adherence to study protocol and Proportion of planned assessments that are completed. Fidelity, which pertains to guaranteeing that the intervention is delivered in accordance with the established protocol, will be summarized by study arms, and differences between arms will be examined using t-tests or two-sample tests of proportions as appropriate. Adherence, which relates to the extent to which participants follow the treatment and study protocol, as well as the proportion of planned assessments completed, will be summarized by study arms, and differences between arms will be examined using t-tests or two-sample tests of proportions as appropriate.
Proportion of retention among participants randomized
时间窗: 6 months
Participants lost to follow-up among those initially randomized.
次要结局
- Treatment Burden and Satisfaction: Diabetes Distress(6 months)
- Episodes and % of time with severe hypoglycemia ( BG <54 mg/dl)(6 months)
- Treatment Burden and Satisfaction: Insulin Treatment Satisfaction(6 months)
- Treatment Burden and Satisfaction: Glucose Monitoring System Satisfaction (GMSS)(6 months)
- Change in A1c(6 months)
- Mean Diabetes Ketoacidosis Episodes Incidence(6 months)
- ED visits/Hospitalizations Number of diabetes related ED visits or hospitalizations(6 months)
- Treatment Burden and Satisfaction: Motivation and Attitudes Towards Changing Health (MATCH)(6 months)
研究者
Estelle M. Everett, MD, MHS
Assistant Professor
University of California, Los Angeles