Effect of 2-Week Continuous Glucose Monitoring on Glycemic Management in Patients New-to-Insulin on Hospital Discharge
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Percentage Change in Hemoglobin A1c (HbA1c)
研究概览
简要总结
The proposed study will be a randomized, prospective, non-blinded study of 120 participants with type 1 or type 2 diabetes that are new-to-insulin on hospital discharge. On hospital discharge, participants will be assigned to either the intervention of wearing a continuous glucose monitor (CGM) for 2 weeks or blood glucose monitoring (BGM) for 2 weeks. They will have a 2-week follow up visit, during which insulin doses will be adjusted as needed, and a 3-month follow-up visit, at which point HbA1c will be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18-100 years
- •Known history of type 1 or type 2 diabetes
- •Admitted to NYU Langone Hospital - Long Island between December 16, 2024- December 31, 2026
- •New initiation of insulin therapy, including basal insulin regimen, basal-bolus insulin regimen, or mixed insulin regimen at the time of hospital discharge
排除标准
- •Prior to admission use of home insulin therapy
- •Current use of systemic corticosteroids
- •Active pregnancy; as pregnancy requires different blood glucose targets, subjects known to be pregnant will be excluded from this study. Subjects will not be tested for pregnancy outside of testing performed in routine medical care; pregnancy will be determined by patient self-reporting. Females of childbearing potential will not be instructed to avoid pregnancy, however if they became pregnant during the study (detected by self-reporting), they will be withdrawn from the study.
研究组 & 干预措施
Blood Glucose Monitoring (BGM)
Patients in the BGM group will be instructed to check their blood glucose utilizing fingerstick glucose monitoring multiple times daily depending on their insulin regimen for 2 weeks duration.
干预措施: Blood Glucose Monitor (Device)
Continuous Glucose Monitoring (CGM)
Patients in the CGM group will be instructed to wear a CGM uninterruptedly for 2 weeks duration.
干预措施: Continuous Glucose Monitor (Device)
结局指标
主要结局
Percentage Change in Hemoglobin A1c (HbA1c)
时间窗: Baseline, Month 3 Post-Discharge
Assessed via CGM or BGM.
次要结局
- Number of Hospital Admissions(Up to Month 3 Post-Discharge)
- Number of Hypoglycemic Events(Up to Month 3 Post-Discharge)
- Number of Emergency Department (ER) Visits(Up to Month 3 Post-Discharge)