Dexcom CGM As Preventative Diagnostic Tool in Steroid-Induced Hyperglycemia During Interventional Pain Management Procedure
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 71
- Locations
- 2
- Primary Endpoint
- Spike in blood glucose level (hyperglycemic phase)
Study Overview
Brief 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), 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
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 19 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
- •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.
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Hospitalization rates(From baseline (day 0) to end of monitoring (day 10))
- Number of phone calls to study team(From baseline (day 0) to end of monitoring (day 10))
Investigators
Mahesh Pattabiraman
Chief Executive
TriCity Research Center