CGM as Diagnostic Tool in Observing Steroid-Induced Hyperglycemia

NCT06628284 | Completed FDA Device

• 1 other identifier: IIS-23-DEX-001
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes; Pain Management

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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)

Study Arms (1)

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

Interventions

Dexcom G7 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).

Test Group

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mahesh Pattabiraman: lead

Study Sites (2)

Grand Island Pain Relief Center

Grand Island, Nebraska, 68803, United States

Location

Hastings Pain Relief Center

Hastings, Nebraska, 68901, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Agnosia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Executive

Study Record Dates

• First Submitted: September 29, 2024
• First Posted: October 4, 2024
• Study Start: April 17, 2024
• Primary Completion: March 21, 2025
• Study Completion: March 21, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

US (2)