Clinical trial NCT06628284: CGM as Diagnostic Tool in Observing Steroid-Induced Hyperglycemia
Official title: Dexcom CGM as Preventative Diagnostic Tool in Steroid-Induced Hyperglycemia During Interventional Pain Management Procedure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Pain Management
Lead sponsor: TriCity Research Center
Sponsor class: INDUSTRY
First posted: 2024-10-04
Enrollment: 71
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

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\&#39;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 \&gt; 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.

Primary outcomes:
measure: Spike in blood glucose level (hyperglycemic phase)
timeFrame: From baseline (day 0) to end of monitoring (day 10)
measure: Duration of hypo- or hyperglycemia
timeFrame: From baseline (day 0) to end of monitoring (day 10)
measure: Drop in blood glucose levels (hypoglycemic phase)
timeFrame: From baseline (day 0) to end of monitoring (day 10)
Secondary outcomes:
measure: Hospitalization rates
timeFrame: From baseline (day 0) to end of monitoring (day 10)
measure: Number of phone calls to study team
timeFrame: From baseline (day 0) to end of monitoring (day 10)
Other outcomes:
Locations:
city: Grand Island
country: United States
facility: Grand Island Pain Relief Center
state: Nebraska
city: Hastings
country: United States
facility: Hastings Pain Relief Center
state: Nebraska
Study officials:
References: