Type 2 Diabetes (T2DM)CGMSteroidNCT07280780
CGM-Based Glycemic Analysis After ESI
An observational study of Type 2 Diabetes (T2DM) and Hyperglycemia, run by Korea University Anam Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Type 2 Diabetes (T2DM), Hyperglycemia, Radicular Pain
- What is being tested?
- Epidural Steroid Injection and Continuous Glucose Monitoring
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Aug 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Korea University Anam Hospital
Seoul, Seoul, 02841
Sunmin Kim, M.D., +82-2-920-5632, k05790@korea.ac.kr
Sunmin Kim, M.D.
About this study
Official title: 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:
Read more
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
Read the 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.
- Conditions
- Type 2 Diabetes (T2DM), Hyperglycemia, Radicular Pain, Spinal Stenosis, Intervertebral Disc Herniation
- Being tested
- Epidural Steroid Injection, Continuous Glucose Monitoring
- Keywords
- epidural steroid injection, Continuous Glucose Monitoring, Dexamethasone, Glycemic Variability, Time in range
- Medical subject headings
- Diabetes Mellitus, Type 2, Hyperglycemia, Spinal Stenosis, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural Steroid InjectionProcedure or surgery
Administration of 5 mg Dexamethasone via epidural route (cervical or lumbar) under fluoroscopic guidance.
Continuous Glucose MonitoringDevice
A sensor attached to the upper arm to monitor interstitial glucose levels continuously for 15 days.
| Study group | Role | What they receive |
|---|---|---|
| Group D (Type 2 Diabetes) | Patients diagnosed with Type 2 Diabetes Mellitus who are scheduled for an epidural steroid injection. Receives: Procedure: Epidural Steroid Injection; Device: Continuous Glucose Monitoring | |
| Group C (Non-Diabetes) | Patients without diabetes who are scheduled for an epidural steroid injection. Receives: Procedure: Epidural Steroid Injection; Device: Continuous Glucose Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Baseline (Day 1-2) and up to 12 days post-injection (Day 15)
Secondary outcomes (4)
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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Up to 12 days post-injection (Day 15)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start5 Aug 2026 (estimated)
- Primary completion20 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Korean Pain Society
- Responsible party
- Principal investigator, Sunmin Kim, Korea University Anam Hospital
- Investigators
- Sunmin Kim, M.D., Study director, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07280780
- Sponsor's protocol ID
- K2025-2728-002
- Acronym
- CGMSteroid
- Status last verified
- Aug 2026
- First submitted
- 1 Dec 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitoring-Based Evaluation of Glycemic Fluctuations Following Epidural Steroid Injections: A Comparative Study by Diabetic Status
- ClinicalTrials.gov ID
- NCT07280780
- Acronym / sponsor ID
- CGMSteroid / K2025-2728-002
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Collaborators
- The Korean Pain Society
- Study start
- 5 Aug 2026 (estimated)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group D (Type 2 Diabetes) | – | Procedure: Epidural Steroid Injection, Device: Continuous Glucose MonitoringPatients diagnosed with Type 2 Diabetes Mellitus who are scheduled for an epidural steroid injection. |
| Group C (Non-Diabetes) | – | Procedure: Epidural Steroid Injection, Device: Continuous Glucose MonitoringPatients without diabetes who are scheduled for an epidural steroid injection. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural Steroid InjectionAdministration of 5 mg Dexamethasone via epidural route (cervical or lumbar) under fluoroscopic guidance. | Procedure or surgery | Group C (Non-Diabetes), Group D (Type 2 Diabetes) |
| Continuous Glucose MonitoringA sensor attached to the upper arm to monitor interstitial glucose levels continuously for 15 days. | Device | Group C (Non-Diabetes), Group D (Type 2 Diabetes) |
Primary outcome
Change in Daily Mean Glucose
Time frame: 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)
Time frame: 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.
4 secondary outcomes
Change in Numeric Rating Scale (NRS)
Time frame: Baseline (Day 1) and Day 15
Frequency of Glucose Spikes
Time frame: Up to 12 days post-injection (Day 15)
Incidence of Nocturnal Hypoglycemia
Time frame: Up to 12 days post-injection (Day 15)
Glucose Variability (Coefficient of Variation)
Time frame: Up to 12 days post-injection (Day 15)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sunmin Kim, M.D. study director
Korea University Anam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes (T2DM) and Hyperglycemia, run by Korea University Anam Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sunmin Kim, M.D. (+82-2-920-5632, k05790@korea.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Daily Mean Glucose (time frame: Baseline (Day 1-2) and up to 12 days post-injection (Day 15)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.