Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
36 participants
OBSERVATIONAL
2025-12-18
2026-12-31
Brief Summary
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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
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group D (Type 2 Diabetes)
Patients diagnosed with Type 2 Diabetes Mellitus who are scheduled for an epidural steroid injection.
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.
Group C (Non-Diabetes)
Patients without diabetes who are scheduled for an epidural steroid injection.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
20 Years
60 Years
ALL
No
Sponsors
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The Korean Pain Society
UNKNOWN
Korea University Anam Hospital
OTHER
Responsible Party
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Sunmin Kim
Clinical Assistant Professor
Principal Investigators
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Sunmin Kim, M.D.
Role: STUDY_DIRECTOR
Korea University Anam Hospital
Locations
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Korea University Anam Hospital
Seoul, Seoul, South Korea
Countries
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Central Contacts
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Facility Contacts
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Sunmin Kim, M.D.
Role: primary
Other Identifiers
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K2025-2728-002
Identifier Type: -
Identifier Source: org_study_id