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临床试验/NCT00309465
NCT00309465已完成4 期

A Study of the Relationship Between the Proportional Insulin Glargine Evening Dose and the Perioperative Serum Glucose Values in Patients With Diabetes Undergoing Surgery

Tamra Dukatz1 个研究点 分布在 1 个国家目标入组 402 人开始时间: 2005年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
402
试验地点
1
主要终点
Primary: Preoperative Fasting Blood Sugar Upon Arrival at the Hospital Prior to Surgery

研究概览

简要总结

The main objective of this study is to compare three strategies of evening insulin glargine dosing to preoperative glucose values in patients with diabetes undergoing surgery to determine which dosing strategies most often achieves the admission target study values of 100-179 mg/dl.

详细描述

There are no evidence-based guidelines for insulin glargine (Lantus) dosing in the perioperative setting. Insulin glargine provides peakless 24-hour coverage of basal insulin needs for people with both Type 1 and Type 2 diabetes. Insulin glargine may be used as the sole insulin or in combination with other rapid-acting insulin to achieve glycemic control.

Anesthesia literature recommends that blood sugar values on insulin-dependent patients be maintained between 120-180 mg/dl in most surgeries. Symptoms of low blood sugar are undetectable in anesthetized patients, and blood glucose is tested at least hourly. Since patients are still awake and alert toward hypoglycemic symptoms in the preoperative area, the admission target study values are 100-179 mg/dl. Glucose values greater than 200 mg/dl have been associated with increased rates of infection, and exacerbated complications if a major cardiovascular event happens.

Frequently insulin glargine is administered in the evening. Patients who are scheduled for surgery in the morning are asked not to eat or drink after midnight. Some endocrinology experts recommend that all or part of the patient's usual insulin glargine should be given to avoid high blood sugar; however, whenever insulin is given without food, the possibility of low blood sugar exists.

  1. Patients in Group 1 will administer 80% of their usual insulin glargine dose.
  2. Group 2 patients will contact their own diabetes care physician and follow those recommendations for the dose.
  3. Group 3 patients will take 50%, 80%, or 100% of their usual insulin glargine dose. Which of those three percentages will be determined by the midpoint of the patient's usual self-reported fasting blood sugar (FBS) range and whether the patients is also taking a rapid-acting insulin.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Scheduled for Surgical Procedure
  • Self Management of Diabetes
  • Currently on Evening Insulin Glargine prescribed by Primary Care Physician
  • Age 18 or over
  • Able to Communicate Clearly over the Phone
  • Pre-screened by Anesthesia Department > 48 hours prior to Surgery

排除标准

  • On Glucocorticoid Medication
  • On Insulin Glargine Dual Dosing or Sliding Scale Regimen
  • History of Hypoglycemia Unawareness
  • Pregnancy or Lactating Female
  • On Insulin Glargine for < 3 months

研究组 & 干预措施

1

Experimental

Patients in Group 1 will administer 80% of their usual insulin glargine dose.

干预措施: Lantus (Drug)

2

Active Comparator

Group 2 patients will contact their own diabetes care physician and follow those recommendations for the dose.

干预措施: Insulin (Other)

3

Experimental

Group 3 patients will take 50%, 80%, or 100% of their usual insulin glargine dose. Which of those three percentages will be determined by the midpoint of the patient's usual self-reported fasting blood sugar (FBS) range and whether the patients is also taking a rapid-acting insulin.

干预措施: Lantus (Drug)

结局指标

主要结局

Primary: Preoperative Fasting Blood Sugar Upon Arrival at the Hospital Prior to Surgery

时间窗: Day 1

Venous blood glucose values were obtained in the preoperative nursing unit. Blood glucose values were analyzed for achievement of target 100-179 mg/dl range and extended 80-249 mg/dl range. Analyses were by intention to treat.

次要结局

未报告次要终点

研究者

发起方
Tamra Dukatz
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Tamra Dukatz

Principal Investigator

William Beaumont Hospitals

研究点 (1)

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