Readiness, Education, and Sustainability for CGM Technology Adoption Model for Older Adults With Insulin-treated Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- The co-primary effectiveness outcomes
研究概览
简要总结
To assess the efficacy of the REST model in facilitating adoption and sustained use of CGM, in older adults with Type 1 diabetes (T1D) or Type 2 Diabetes (T2D) on complex insulin regimens. To examine barriers and enablers for the implementation feasibility of the REST intervention model using a mixed-methods approach. To assess the impact of REST model on economic factors and quality of life measures. The goal of this study is to facilitate the adoption of continuous glucose monitoring (CGM) in older adults (≥65 years) with diabetes mellitus (DM) on complex insulin regimens, and additionally, to build a framework for sustained CGM use over time using a novel patient-centered model - the REST model.
详细描述
Older adults with diabetes on multiple insulin injections are at greater risk of hypoglycemia and its poor outcomes. Use of continuous glucose monitoring (CGM) has shown to improve glycemic control and reduce hypoglycemia in this age group. Despite Medicare coverage for CGM, uptake in this age group is still low. The goal of this study is to facilitate the adoption of continuous glucose monitoring (CGM) in older adults (≥65 years) with diabetes mellitus (DM) on complex insulin regimens, and additionally, to build a framework for sustained CGM use over time using a novel patient-centered model - the REST model. This model will assess Readiness and barriers to CGM initiation and utilization, provide remote Education, and implement a framework for Sustainability of CGM Technology adoption. The study will assess the impact of the REST model and its ability to increase CGM uptake and use in this age group, as well as its effectiveness on improving glycemic metrics. The study will also evaluate the impact of the REST model on economic and health-related quality-of-life measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older adults age ≥65 years
- •T1D or T2D with duration longer than 1 year
- •Insulin treatment includes: ≥3 insulin injections/day or on insulin pump therapy
- •CGM naïve and/or CGM users (Dexcom G6) who are not meeting glycemic goals (per
- •CGM metrics):
- •≥4% hypoglycemia (sensor glucose ≤70 mg/dL) or
- •time in range (70-180 mg/dL) TIR ≤40 %
- •Willing to wear CGM Dexcom at all times while in the study
- •Willing to use/carry personal or loaned smart phone device to use as Dexcom receiver for continual data upload to cloud
排除标准
- •Life expectancy <1 year
- •End-stage renal disease (eGFR< 30ml/min)
- •On acetaminophen >4 gr/day due to interference with Dexcom G6 sensor readings
- •On hydroxyurea therapy due to interference with Dexcom G6 sensor readings
- •Impaired vision and hearing which would interfere with participation in remote video visits
- •Use of hybrid closed-loop systems (this may require different and additional focused education and will not be addressed in this study).
研究组 & 干预措施
Single Arm
干预措施: Continuous Glucose Monitor (Device)
结局指标
主要结局
The co-primary effectiveness outcomes
时间窗: Baseline to 6 months
Change in time spent in hypoglycemia (sensor glucose \<70 mg/dL and ii) Change in individualized Time in Range goal
The co-primary implementation outcomes
时间窗: Baseline vs 6 months
Change in adoption of CGM by remote education (change in number of CGM users and ii) change in number of hours of CGM use per week
次要结局
- Visits to maintain CGM use(6 months)
- Resource utilization(Baseline vs 6 months)
- Resource utilization(6 months vs 12 months)
- Time spent in hypoglycemia(6 months vs 12 months)
- Diabetes health related quality of life measures(Baseline vs 6 months)
- Cost Effectivness(12 months)
- Visits to maintain CGM use(Month 12)
- Cost effectivness(6 months)