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临床试验/NCT06628284
NCT06628284已完成不适用

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

Mahesh Pattabiraman2 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2024年4月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
71
试验地点
2
主要终点
Spike in blood glucose level (hyperglycemic phase)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
19 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Spike in blood glucose level (hyperglycemic phase)

时间窗: From baseline (day 0) to end of monitoring (day 10)

Hyperglycemic phase is determined based on clinically significant increase in percentage points above baseline

Duration of hypo- or hyperglycemia

时间窗: From baseline (day 0) to end of monitoring (day 10)

minutes of blood glucose level in hypo-/hyperglycemic phase

Drop in blood glucose levels (hypoglycemic phase)

时间窗: From baseline (day 0) to end of monitoring (day 10)

Hypoglycemic phase is determined based on clinically significant decrease in percentage points below baseline

次要结局

  • 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))

研究者

发起方
Mahesh Pattabiraman
申办方类型
Industry
责任方
Sponsor Investigator
主要研究者

Mahesh Pattabiraman

Chief Executive

TriCity Research Center

研究点 (2)

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