CGM as Diagnostic Tool in Observing Steroid-Induced Hyperglycemia

NCT ID: NCT06628284

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 71 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-17
• Study Completion Date: 2025-03-21

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.

Conditions

Diabetes; Pain Management

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Dexcom G7

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mahesh Pattabiraman

INDUSTRY

Sponsor Role: lead

Responsible Party

Mahesh Pattabiraman

Chief Executive

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Grand Island Pain Relief Center

Grand Island, Nebraska, United States

Hastings Pain Relief Center

Hastings, Nebraska, United States

Countries

United States

Other Identifiers

IIS-23-DEX-001

Identifier Type: -

Identifier Source: org_study_id