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NCT07280780
CGM-Based Glycemic Analysis After ESI
Conditions: Type 2 Diabetes (T2DM), Hyperglycemia, Radicular Pain, Spinal Stenosis, Intervertebral Disc Herniation
Sex: All
Ages: 20 Years – 60 Years
Healthy volunteers: No
Enrollment: 36
Sponsor: Korea University Anam Hospital
Location: Korea University Anam Hospital Seoul Seoul
Summary
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
Eligibility Criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Source: ClinicalTrials.gov (NCT07280780). StuddyBuddy aggregates publicly available trial information.