Pragmatic Clinical Trial of Continuous Glucose Monitoring-based Interventions for Safe Insulin Use in High-Risk Older Adults With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 14
- 主要终点
- Hypoglycemia aggregate outcome
研究概览
简要总结
Older adults with type 2 diabetes are at higher risk for severe hypoglycemia and its related complications (including hospitalization and death) when taking insulin. This study proposes to evaluate, in a randomized clinical trial, a strategy of safe insulin prescribing based on an educational program that leverages continuous glucose monitoring to support older adults at high risk for hypoglycemia. If the aims of this project are achieved, this novel care strategy could be widely applied to reduce severe hypoglycemia episodes in older, high-risk adults with type 2 diabetes.
详细描述
The overarching goal of this pragmatic randomized clinical trial is to support safer diabetes care in older adults (age ≥ 75) with type 2 diabetes (T2D) who require insulin therapy. Many of these older adults are at high risk for severe hypoglycemia due to symptom unawareness and/or nocturnal hypoglycemia. Effective and safe management in this population requires close glucose monitoring coupled with proactive medication and diet adjustment to avoid severe iatrogenic consequences. This study proposes to achieve this goal through a patient-oriented intervention program that incorporates the use of alarm-enabled continuous glucose monitoring (CGM). There are currently no major randomized trials directly assessing the use of CGM to reduce severe hypoglycemia among the oldest adults with T2D. The study team will conduct a 2-arm trial: 1) Group-based, three-session education intervention (CGM provided to participants) vs. 2) usual care (no CGM provided to participants). The primary outcome is an aggregate measure of clinically significant hypoglycemia. The study will also examine differences in patient-reported diabetes distress, fear of hypoglycemia, and self-efficacy using validated survey measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participant randomization status will be masked during data collection (baseline and follow-up surveys) by research assistants
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 75 years and older
- •Diagnosis of Type 2 Diabetes
- •Current treatment with insulin
- •Increased hypoglycemia risk (prior year hypoglycemia by self-report or utilization)
- •Able to communicate in English
- •Able to access email and the Internet
排除标准
- •On renal dialysis
- •Pacemaker or Automatic Implantable Cardioverter Defibrillator
- •Using insulin pump
- •Severe Mental Illness
- •Severe Visual Impairment
- •In Hospice
- •Current or recent CGM use
研究组 & 干预措施
Group Education Sessions
Participants will participate in 3 educational sessions designed to teach about applying and using continuous glucose monitors [CGMs] (Session 1) and how to prevent hypoglycemia episodes based on CGM readings and hypoglycemia journal entries (Sessions 2 & 3).
干预措施: SAGE Group Sessions (Behavioral)
Usual Care
Participants allocated to the control arm will continue with usual care.
干预措施: Usual Care (Other)
结局指标
主要结局
Hypoglycemia aggregate outcome
时间窗: 6 and 12 months after study start date
This outcome will compare the proportion of patients in the three study arms with self-reported hypoglycemia (symptomatic and/or requiring help from others) and/or hypoglycemia-related utilization (emergency department, hospital or outpatient new events) 6- and 12-months after enrollment
次要结局
- Diabetes Distress(6 and 12 months after study start date)
- Hypoglycemia Distress(6 and 12 months after study start date)
- Self-reported hypoglycemia(6 and 12 months after study start date)
- Hypoglycemia-related utilization(6 and 12 months after study start date)
- Hypoglycemia Confidence(6 and 12 months after study start date)