CGM As Diagnostic Tool in Observing Steroid-Induced Hyperglycemia (TRC-DX-1)

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.

Study Overview

• Status: Completed
• Conditions: Diabetes; Pain Management
• Intervention / Treatment: Device: Dexcom G7

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 Type: Observational
• Enrollment (Actual): 71

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Grand Island, Nebraska, United States, 68803
      • Grand Island Pain Relief Center
    • Hastings, Nebraska, United States, 68901
      • Hastings Pain Relief Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spike in blood glucose level (hyperglycemic phase)	Hyperglycemic phase is determined based on clinically significant increase in percentage points above baseline	From baseline (day 0) to end of monitoring (day 10)
Duration of hypo- or hyperglycemia	minutes of blood glucose level in hypo-/hyperglycemic phase	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	From baseline (day 0) to end of monitoring (day 10)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization rates	Electronic health record analysis	From baseline (day 0) to end of monitoring (day 10)
Number of phone calls to study team	Analysis of electronic health records	From baseline (day 0) to end of monitoring (day 10)

Collaborators and Investigators

• Sponsor: Mahesh Pattabiraman

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2024
• Primary Completion (Actual): March 21, 2025
• Study Completion (Actual): March 21, 2025

Study Registration Dates

• First Submitted: September 29, 2024
• First Submitted That Met QC Criteria: October 2, 2024
• First Posted (Actual): October 4, 2024

Study Record Updates

• Last Update Posted (Actual): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 21, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Hyperglycemia
• Other Study ID Numbers: IIS-23-DEX-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No