NCT06628284

CGM as Diagnostic Tool in Observing Steroid-Induced Hyperglycemia

Dexcom CGM as Preventative Diagnostic Tool in Steroid-Induced Hyperglycemia During Interventional Pain Management Procedure

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 71 (actual)
• Sponsor: Mahesh Pattabiraman · Industry
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diabetes
• Pain Management

Interventions

Type	Name	Description
DEVICE	Dexcom G7	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).

Timeline

• Start date: 2024-04-17
• Primary completion: 2025-03-21
• Completion: 2025-03-21
• First posted: 2024-10-04
• Last updated: 2025-03-26

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study