DiabetesTRC-DX-1NCT06628284
CGM as Diagnostic Tool in Observing Steroid-Induced Hyperglycemia
An observational study of Diabetes and Pain Management, run by Mahesh Pattabiraman at 2 sites in United States.
Trial summary
This study is designed to help understand how certain steroid medications affect blood sugar levels in patients undergoing pain management treatments. Patients who receive steroid injections for conditions like back pain or arthritis experience temporary high blood sugar (called steroid-induced hyperglycemia, SIH)… Read more about this study
- Who is it for?
- Ages 19 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Pain Management
- What is being tested?
- Dexcom G7
- Type of treatment
- Medical device
- How many people
- 71 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Apr 2024to 21 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 19 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study will enroll adult participants aged 19-75 years who are undergoing interventional pain management procedures requiring corticosteroid administration. Participants must be willing and able to use the Dexcom G7 Continuous Glucose Monitoring system and install the corresponding app on their smartphones. Eligible participants must meet the medical criteria for corticosteroid use in pain management, as determined by the principal investigator, and must provide informed consent prior to participation. Exclusion criteria include pregnancy, medically unmanaged diabetes, history of severe hypoglycemia or diabetic ketoacidosis, active infections, or any conditions that would make the study unsafe or infeasible as determined by the investigator
Who may be able to join
- Adults aged 19-75 years
- Patients meeting the medical criteria for need of interventional pain management procedure requiring corticosteroid administration.
- Willing and able to use Dexcom\'s CGM device.
- Willing to install Dexcom G7 app in their phone and register it for cloud data sharing
- Able to understand and sign informed consent
Who cannot join
- Pregnancy or lactation
- Medically unmanaged diabetes
- History of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS)
- History of severe hypoglycemia
- Active infection
- History of a liver disorder (ALT \> threefold of the ULN)
Show all 11Show fewer
- History of any renal disease
- Immune compromised patient
- Active illegal drug user (self-reported)
- Under any other steroid treatment
- Any other medical condition or treatment that would make participation in the study unsafe or infeasible.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Grand Island Pain Relief Center
Grand Island, Nebraska, 68803
Hastings Pain Relief Center
Hastings, Nebraska, 68901
About this study
Official title: Dexcom CGM as Preventative Diagnostic Tool in Steroid-Induced Hyperglycemia During Interventional Pain Management Procedure
This study is designed to help understand how certain steroid medications affect blood sugar levels in patients undergoing pain management treatments. Patients who receive steroid injections for conditions like back pain or arthritis experience temporary high blood sugar (called steroid-induced hyperglycemia, SIH), which can sometimes lead to complications, especially in patients with diabetes. This study aims to understand this by monitoring blood glucose levels using continuous glucose monitors (Dexcom G7). The main goal of this study is to track how steroid injections impact blood sugar levels in patients.
Read the detailed description
Steroid injections are frequently used in pain management for conditions such as arthritis, back pain, and joint inflammation. While effective at reducing pain and inflammation, these steroids can cause temporary spikes in blood sugar, known as steroid-induced hyperglycemia. This can be a concern, especially for patients with diabetes, as poorly managed high blood sugar can lead to serious complications. This study aims to explore the effects of three commonly used steroids: dexamethasone, methylprednisolone, and triamcinolone, each administered at different doses. Participants will be fitted with a Dexcom G7 continuous glucose monitor (CGM) on their arm, which will track their blood sugar levels every 5 minutes for up to 10 days.
The study's primary objective is to determine how often steroid-induced hyperglycemia occurs, how severe it is, and how long it lasts. Study will also investigate whether certain factors-such as the type of steroid, dosage, or the patient's underlying conditions-affect blood sugar responses. Additionally, the study will assess how the use of the CGM device may improve overall patient care, reduce the need for emergency interventions, and potentially lower healthcare costs by preventing complications.
By gathering high-resolution glucose data, this research will provide valuable insights into the best practices for managing blood sugar in patients receiving steroid injections. Our goal is to improve treatment strategies, particularly for diabetic patients, ensuring safer and more effective pain management.
- Conditions
- Diabetes, Pain Management
- Being tested
- Dexcom G7
- Medical subject headings
- Diabetes Mellitus, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexcom G7Device
The study will be conducted as a single-arm trial consisting of participants enrolled in the test group. Each participant will receive a G7 CGM and their blood glucose levels will be continuously transmitted to the Dexcom Clarity system for monitoring and data collection. As a observational study, the test group glucose levels will be monitored after receiving a steroid for pain management. The CGM profile of steroid-induced hyperglycemia in patients will be studied for the following corticosteroids: dexamethasone (10 mg), methylprednisolone (40 mg or 80 mg), triamcinolone (40 mg or 80 mg).
| Study group | Role | What they receive |
|---|---|---|
| Test Group | The study will be conducted as a single-arm trial consisting of participants enrolled in the test group. Each participant will receive a G7 CGM and their blood glucose levels will be continuously transmitted to the Dexcom Clarity cloud system for monitoring and data collection. Receives: Device: Dexcom G7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spike in blood glucose level (hyperglycemic phase)
Hyperglycemic phase is determined based on clinically significant increase in percentage points above baseline
Measured: From baseline (day 0) to end of monitoring (day 10)
Duration of hypo- or hyperglycemia
minutes of blood glucose level in hypo-/hyperglycemic phase
Measured: From baseline (day 0) to end of monitoring (day 10)
Drop in blood glucose levels (hypoglycemic phase)
Hypoglycemic phase is determined based on clinically significant decrease in percentage points below baseline
Measured: From baseline (day 0) to end of monitoring (day 10)
Secondary outcomes (2)
Hospitalization rates
Electronic health record analysis
Measured: From baseline (day 0) to end of monitoring (day 10)
Number of phone calls to study team
Analysis of electronic health records
Measured: From baseline (day 0) to end of monitoring (day 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start17 Apr 2024
- Primary completion21 Mar 2025
- Study completion21 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahesh Pattabiraman
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Mahesh Pattabiraman, TriCity Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628284
- Sponsor's protocol ID
- IIS-23-DEX-001
- Acronym
- TRC-DX-1
- Status last verified
- Mar 2025
- First submitted
- 29 Sep 2024
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: The research team is open to sharing individual participant data with qualified researchers who meet the appropriate criteria for data access. However, the team may decide against sharing due to concerns about the sensitive nature of the glucose monitoring data, the potential risks of re-identification even with anonymized datasets, and the need to protect patient confidentiality. Additionally, data governance and patient consent considerations may also influence the decision to withhold IPD sharing.
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexcom CGM as Preventative Diagnostic Tool in Steroid-Induced Hyperglycemia During Interventional Pain Management Procedure
- ClinicalTrials.gov ID
- NCT06628284
- Acronym / sponsor ID
- TRC-DX-1 / IIS-23-DEX-001
- Conditions
- Diabetes, Pain Management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Mahesh PattabiramanIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 21 Mar 2025 (actual)
- Study completion
- 21 Mar 2025 (actual)
- First posted
- 4 Oct 2024 (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.
This study is designed to help understand how certain steroid medications affect blood sugar levels in patients undergoing pain management treatments. Patients who receive steroid injections for conditions like back pain or arthritis experience temporary high blood sugar (called steroid-induced hyperglycemia, SIH), which can sometimes lead to complications, especially in patients with diabetes. This study aims to understand this by monitoring blood glucose levels using continuous glucose monitors (Dexcom G7). The main goal of this study is to track how steroid injections impact blood sugar levels in patients.
Detailed description
Steroid injections are frequently used in pain management for conditions such as arthritis, back pain, and joint inflammation. While effective at reducing pain and inflammation, these steroids can cause temporary spikes in blood sugar, known as steroid-induced hyperglycemia. This can be a concern, especially for patients with diabetes, as poorly managed high blood sugar can lead to serious complications. This study aims to explore the effects of three commonly used steroids: dexamethasone, methylprednisolone, and triamcinolone, each administered at different doses. Participants will be fitted with a Dexcom G7 continuous glucose monitor (CGM) on their arm, which will track their blood sugar levels every 5 minutes for up to 10 days.
The study's primary objective is to determine how often steroid-induced hyperglycemia occurs, how severe it is, and how long it lasts. Study will also investigate whether certain factors-such as the type of steroid, dosage, or the patient's underlying conditions-affect blood sugar responses. Additionally, the study will assess how the use of the CGM device may improve overall patient care, reduce the need for emergency interventions, and potentially lower healthcare costs by preventing complications.
By gathering high-resolution glucose data, this research will provide valuable insights into the best practices for managing blood sugar in patients receiving steroid injections. Our goal is to improve treatment strategies, particularly for diabetic patients, ensuring safer and more effective pain management.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test Group | – | Device: Dexcom G7The study will be conducted as a single-arm trial consisting of participants enrolled in the test group. Each participant will receive a G7 CGM and their blood glucose levels will be continuously transmitted to the Dexcom Clarity cloud system for monitoring and data collection. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll adult participants aged 19-75 years who are undergoing interventional pain management procedures requiring corticosteroid administration. Participants must be willing and able to use the Dexcom G7 Continuous Glucose Monitoring system and install the corresponding app on their smartphones. Eligible participants must meet the medical criteria for corticosteroid use in pain management, as determined by the principal investigator, and must provide informed consent prior to participation. Exclusion criteria include pregnancy, medically unmanaged diabetes, history of severe hypoglycemia or diabetic ketoacidosis, active infections, or any conditions that would make the study unsafe or infeasible as determined by the investigator
Key inclusion criteria (5 listed)
- Adults aged 19-75 years
- Patients meeting the medical criteria for need of interventional pain management procedure requiring corticosteroid administration.
- Willing and able to use Dexcom\'s CGM device.
- Willing to install Dexcom G7 app in their phone and register it for cloud data sharing
- Able to understand and sign informed consent
Key exclusion criteria (11 listed)
- Pregnancy or lactation
- Medically unmanaged diabetes
- History of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS)
- History of severe hypoglycemia
- Active infection
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 |
|---|---|---|
| Dexcom G7The study will be conducted as a single-arm trial consisting of participants enrolled in the test group. Each participant will receive a G7 CGM and their blood glucose levels will be continuously transmitted to the Dexcom Clarity system for monitoring and data collection. As a observational study, the test group glucose levels will be monitored after receiving a steroid for pain management. The CGM profile of steroid-induced hyperglycemia in patients will be studied for the following corticosteroids: dexamethasone (10 mg), methylprednisolone (40 mg or 80 mg), triamcinolone (40 mg or 80 mg). | Device | Test Group |
Primary outcome
Spike in blood glucose level (hyperglycemic phase)
Time frame: From baseline (day 0) to end of monitoring (day 10)
Hyperglycemic phase is determined based on clinically significant increase in percentage points above baseline
Duration of hypo- or hyperglycemia
Time frame: From baseline (day 0) to end of monitoring (day 10)
minutes of blood glucose level in hypo-/hyperglycemic phase
Drop in blood glucose levels (hypoglycemic phase)
Time frame: From baseline (day 0) to end of monitoring (day 10)
Hypoglycemic phase is determined based on clinically significant decrease in percentage points below baseline
2 secondary outcomes
Hospitalization rates
Time frame: From baseline (day 0) to end of monitoring (day 10)
Number of phone calls to study team
Time frame: From baseline (day 0) to end of monitoring (day 10)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: Undecided. The research team is open to sharing individual participant data with qualified researchers who meet the appropriate criteria for data access. However, the team may decide against sharing due to concerns about the sensitive nature of the glucose monitoring data, the potential risks of re-identification even with anonymized datasets, and the need to protect patient confidentiality. Additionally, data governance and patient consent considerations may also influence the decision to withhold IPD sharing.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Pain Management, run by Mahesh Pattabiraman at 2 sites in United States.
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 5 inclusion and 11 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: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spike in blood glucose level (hyperglycemic phase) (time frame: From baseline (day 0) to end of monitoring (day 10)). The study lists 3 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 26 Mar 2025.