CGM-Based Glycemic Analysis After ESI

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-60
SponsorKorea University Anam Hospital

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Epidural Steroid Injection
  • Continuous Glucose Monitoring

Treatment groups

36 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Korea University Anam Hospital

Lead sponsor

The Korean Pain Society

Collaborator