Continuous Glucose Monitoring-Based Evaluation of Glycemic Fluctuations Following Epidural Steroid Injections: A Comparative Study by Diabetic Status
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in Daily Mean Glucose
研究概览
简要总结
The goal of this clinical study is to learn how blood glucose levels change after an epidural steroid injection (ESI) with dexamethasone in adults. It will specifically compare the glycemic response between patients with type 2 diabetes and those without diabetes.
The main questions it aims to answer are:
Does the injection cause higher or longer-lasting blood glucose elevation in diabetic patients compared to non-diabetic patients? How do the mean glucose level and Time in Range (TIR) change after the injection in both groups?
Researchers will compare a Type 2 Diabetes group to a Non-Diabetes group to see the differences in glycemic fluctuations using a continuous glucose monitoring (CGM) device.
Participants will:
- Wear a small CGM sensor on their arm for about 15 days to monitor blood glucose levels continuously
- Receive an epidural steroid injection containing 5 mg of dexamethasone on Day 3
- Visit the clinic 3 times (Day 1, Day 3, and Day 15) for sensor attachment, the injection procedure, and data collection
详细描述
Epidural steroid injections (ESIs) are a widely used non-surgical treatment for radicular pain caused by spinal conditions such as herniated discs and spinal stenosis. While effective for pain relief, the systemic absorption of corticosteroids (e.g., dexamethasone) can induce temporary hyperglycemia, which poses potential risks, particularly for patients with type 2 diabetes mellitus (T2DM).
Previous studies on post-ESI hyperglycemia have largely relied on self-monitoring of blood glucose (SMBG), which captures only intermittent glucose data and may miss significant glycemic excursions, such as postprandial spikes or nocturnal hypoglycemia. This study aims to overcome these limitations by using a Continuous Glucose Monitoring (CGM) system to provide a comprehensive, time-series analysis of glycemic fluctuations.
Objectives:
To compare glycemic changes (mean glucose, Time in Range [TIR], Time Above Range [TAR]) following an epidural steroid injection with 5 mg of dexamethasone between a type 2 diabetes group and a non-diabetes control group.
To investigate the correlation between baseline HbA1c levels and the magnitude of post-injection glycemic variability.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 20 to 60 years.
- •Patients scheduled for cervical or lumbar epidural steroid injection at the pain clinic.
- •Patients capable of understanding and using a Continuous Glucose Monitoring (CGM) device.
排除标准
- •Patients currently taking or administering steroid medications.
- •Patients with Type 1 Diabetes Mellitus.
- •Patients with Cushing's disease.
- •Patients who have received an epidural steroid injection within the last 3 months.
- •Patients with a known allergy to contrast media.
- •Patients taking anticoagulants or antiplatelet agents.
- •Patients unable to use a Continuous Glucose Monitoring (CGM) device.
研究组 & 干预措施
Group C (Non-Diabetes)
Patients without diabetes who are scheduled for an epidural steroid injection.
干预措施: Epidural Steroid Injection (Procedure)
Group C (Non-Diabetes)
Patients without diabetes who are scheduled for an epidural steroid injection.
干预措施: Continuous Glucose Monitoring (Device)
Group D (Type 2 Diabetes)
Patients diagnosed with Type 2 Diabetes Mellitus who are scheduled for an epidural steroid injection.
干预措施: Epidural Steroid Injection (Procedure)
Group D (Type 2 Diabetes)
Patients diagnosed with Type 2 Diabetes Mellitus who are scheduled for an epidural steroid injection.
干预措施: Continuous Glucose Monitoring (Device)
结局指标
主要结局
Change in Daily Mean Glucose
时间窗: Baseline (Day 1-2) and up to 12 days post-injection (Day 15)
The difference in daily mean glucose levels (mg/dL) measured by CGM between the baseline period (Day 1-2) and the post-injection period (Day 3-15).
Change in Time in Range (TIR)
时间窗: Baseline (Day 1-2) and up to 12 days post-injection (Day 15)
The difference in the percentage of time (%) spent within the target glucose range (70-180 mg/dL) between the baseline period and the post-injection period.
次要结局
- Frequency of Glucose Spikes(Up to 12 days post-injection (Day 15))
- Change in Numeric Rating Scale (NRS)(Baseline (Day 1) and Day 15)
- Incidence of Nocturnal Hypoglycemia(Up to 12 days post-injection (Day 15))
- Glucose Variability (Coefficient of Variation)(Up to 12 days post-injection (Day 15))
研究者
Sunmin Kim
Clinical Assistant Professor
Korea University Anam Hospital