An observational study in Type 2 Diabetes (T2DM), Hyperglycemia and Radicular Pain, sponsored by Korea University Anam Hospital. Not yet recruiting at 1 site in South Korea. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Korea University Anam Hospital · Observational
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:
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):
Visit 2 (Day 3 - Intervention):
Visit 3 (Day 15 - Follow-up \& Data Collection):
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 36 is below the median of 300 across 1,741 observational studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Korea University Anam Hospital is the lead sponsor of 112 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients visiting the Pain Clinic at Korea University Anam Hospital who are scheduled for cervical or lumbar epidural steroid injections due to spinal pain.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients diagnosed with Type 2 Diabetes Mellitus who are scheduled for an epidural steroid injection.
Procedure: Epidural Steroid Injection · Device: Continuous Glucose Monitoring
Patients without diabetes who are scheduled for an epidural steroid injection.
Procedure: Epidural Steroid Injection · Device: Continuous Glucose Monitoring
Administration of 5 mg Dexamethasone via epidural route (cervical or lumbar) under fluoroscopic guidance.
A sensor attached to the upper arm to monitor interstitial glucose levels continuously for 15 days.
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).
Time frame: 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.
Time frame: Baseline (Day 1-2) and up to 12 days post-injection (Day 15)
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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Up to 12 days post-injection (Day 15)
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Dec 2026, 4 months later.
Of 432 non-industry observational studies under Diabetes Mellitus, Type 2, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 96. This study's planned 4 months is below that.
Counting every sponsor, half of 602 studies reached it within 32 months; a quarter within 17 and three quarters within 62.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Korea University Anam Hospital →