CGM-Based Glycemic Analysis After ESI

Condition(s) studied

Investigational drug(s) / intervention(s)

Epidural Steroid Injection: Administration of 5 mg Dexamethasone via epidural route (cervical or lumbar) under fluoroscopic guidance.

Continuous Glucose Monitoring: A sensor attached to the upper arm to monitor interstitial glucose levels continuously for 15 days.

Study 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

Primary outcome measure(s)

• Change in Daily Mean Glucose — 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) — 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.

Trial sites (1)

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