CGM-Based Glycemic Analysis After ESI

NCT07280780 | Not Yet Recruiting

• 1 other identifier: K2025-2728-002
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Type 2 Diabetes (T2DM); Hyperglycemia; Radicular Pain; Spinal Stenosis; Intervertebral Disc Herniation

Keywords

epidural steroid injection; Continuous Glucose Monitoring; Dexamethasone; Glycemic Variability; Time in range

Outcome Measures

Primary Outcomes (2)

• Change in Daily Mean Glucose

  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).

  Baseline (Day 1-2) and up to 12 days post-injection (Day 15)

• Change in Time in Range (TIR)

  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.

  Baseline (Day 1-2) and up to 12 days post-injection (Day 15)

Secondary Outcomes (4)

• Change in Numeric Rating Scale (NRS)

  Baseline (Day 1) and Day 15

• Frequency of Glucose Spikes

  Up to 12 days post-injection (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)

Study Arms (2)

Group D (Type 2 Diabetes)

Patients diagnosed with Type 2 Diabetes Mellitus who are scheduled for an epidural steroid injection.

Procedure: Epidural Steroid Injection; Device: Continuous Glucose Monitoring

Group C (Non-Diabetes)

Patients without diabetes who are scheduled for an epidural steroid injection.

Procedure: Epidural Steroid Injection; Device: Continuous Glucose Monitoring

Interventions

Epidural Steroid Injection PROCEDURE

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

Group C (Non-Diabetes); Group D (Type 2 Diabetes)

Continuous Glucose Monitoring DEVICE

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

Group C (Non-Diabetes); Group D (Type 2 Diabetes)

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients visiting the Pain Clinic at Korea University Anam Hospital who are scheduled for cervical or lumbar epidural steroid injections due to spinal pain.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Korea University Anam Hospital: lead
• The Korean Pain Society: collaborator

Study Sites (1)

Korea University Anam Hospital

Seoul, Seoul, 02841, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hyperglycemia; Spinal Stenosis; Intervertebral Disc Displacement

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Sunmin Kim, M.D.

  Korea University Anam Hospital

  STUDY DIRECTOR

Central Study Contacts

Sunmin Kim, M.D.

CONTACT

+82-2-920-5632; k05790@korea.ac.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 12, 2025
• Study Start: April 20, 2026
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)