CGM-Based Glycemic Analysis After ESI (CGMSteroid)

Continuous Glucose Monitoring-Based Evaluation of Glycemic Fluctuations Following Epidural Steroid Injections: A Comparative Study by Diabetic Status

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

Study Overview

• Status: Not yet recruiting
• Conditions: Hyperglycemia; Spinal Stenosis; Type 2 Diabetes (T2DM); Radicular Pain; Intervertebral Disc Herniation
• Intervention / Treatment: Procedure: Epidural Steroid Injection; Device: Continuous Glucose Monitoring

Detailed Description

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.

Study Design: This is a prospective, observational, comparative study conducted at a single center (Korea University Anam Hospital). A total of 36 participants (18 in the T2DM group and 18 in the Non-DM group) will be enrolled.

Study Procedures:

Visit 1 (Day 1 - Screening & Baseline):

• Participants provide informed consent and undergo screening.
• Baseline HbA1c is measured.
• A CGM sensor (Abbott FreeStyle Libre 2) is attached to the participant's upper arm.
• Participants receive education on CGM use and are instructed to maintain their usual diet and medication.
• Baseline Data Collection: Glucose levels are monitored for 2 days (Day 1-2) to establish a baseline profile before the injection.

Visit 2 (Day 3 - Intervention):

• Participants undergo the scheduled epidural steroid injection (cervical or lumbar) using 5 mg of dexamethasone.
• The procedure is performed under fluoroscopic guidance according to standard clinical practice.

Visit 3 (Day 15 - Follow-up & Data Collection):

• Participants return to the clinic for follow-up.
• The CGM sensor is removed, and the stored glycemic data is downloaded.
• Pain intensity (Numeric Rating Scale, NRS) and any adverse events are recorded.

Statistical Analysis: The primary endpoints (changes in mean daily glucose and TIR) will be analyzed using a Linear Mixed Model (LMM) to account for repeated measures. Fixed effects will include Group (DM vs. Non-DM), Time (Baseline vs. Post-injection), and the Group-by-Time interaction. Patient demographics (e.g., age, BMI) will be included as covariates if significant differences are observed at baseline. A p-value of <0.05 will be considered statistically significant.

This study will provide high-resolution data on the duration and severity of steroid-induced hyperglycemia, contributing to safer pain management protocols for diabetic patients.

• Study Type: Observational
• Enrollment (Estimated): 36

Contacts and Locations

• Study Contact: Name: Sunmin Kim, M.D.; Phone Number: +82-2-920-5632; Email: k05790@korea.ac.kr

Study Locations

• South Korea
  • Seoul
    • Seoul, Seoul, South Korea, 02841
      • Korea University Anam Hospital
      • Contact: Sunmin Kim, M.D.; Phone Number: +82-2-920-5632; Email: k05790@korea.ac.kr
      • Principal Investigator: Sunmin Kim, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group D (Type 2 Diabetes); Patients diagnosed with Type 2 Diabetes Mellitus who are scheduled for an epidural steroid injection.	Procedure: Epidural Steroid Injection; Administration of 5 mg Dexamethasone via epidural route (cervical or lumbar) under fluoroscopic guidance.; Device: Continuous Glucose Monitoring; A sensor attached to the upper arm to monitor interstitial glucose levels continuously for 15 days.
Group C (Non-Diabetes); Patients without diabetes who are scheduled for an epidural steroid injection.	Procedure: Epidural Steroid Injection; Administration of 5 mg Dexamethasone via epidural route (cervical or lumbar) under fluoroscopic guidance.; Device: Continuous Glucose Monitoring; A sensor attached to the upper arm to monitor interstitial glucose levels continuously for 15 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Numeric Rating Scale (NRS)	The change in pain intensity scores reported by participants. The scale ranges from 0 (no pain) to 10 (worst possible pain).	Baseline (Day 1) and Day 15
Frequency of Glucose Spikes	The number of hyperglycemic events defined as glucose levels >180 mg/dL lasting for at least 30 minutes.	Up to 12 days post-injection (Day 15)
Incidence of Nocturnal Hypoglycemia	The percentage of participants experiencing glucose levels <70 mg/dL during the nighttime period (22:00 to 06:00).	Up to 12 days post-injection (Day 15)
Glucose Variability (Coefficient of Variation)	The coefficient of variation (%CV) of glucose levels, calculated as the standard deviation divided by the mean glucose, to assess glycemic variability.	Up to 12 days post-injection (Day 15)

Collaborators and Investigators

• Sponsor: Korea University Anam Hospital
• Collaborators: The Korean Pain Society
• Investigators: Study Director: Sunmin Kim, M.D., Korea University Anam Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 20, 2026
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: December 1, 2025
• First Posted (Actual): December 12, 2025

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Continuous Glucose Monitoring; Dexamethasone; Time in range; Glycemic Variability; epidural steroid injection
• Additional Relevant MeSH Terms: Endocrine System Diseases; Bone Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Spinal Diseases; Hernia; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Intervertebral Disc Displacement; Spinal Stenosis; Hyperglycemia; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Blood Chemical Analysis; Clinical Chemistry Tests; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Continuous Glucose Monitoring
• Other Study ID Numbers: K2025-2728-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No