The Safety and Efficacy of Correcting Preoperative Hyperglycemia in Ambulatory Surgical Patients With Diabetes: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- BG concentration differences at 1 and 2 hours post intervention and post operatively
研究概览
简要总结
The purpose of this study is to compare the safety and efficacy of intravenous (IV) administration of FDA approved regular human insulin and subcutaneous (SC) administration of humalog, a rapid-acting insulin analog (a synthetic insulin), for correction of hyperglycemia (high blood sugar) during the immediate preoperative period in patients with diabetes having outpatient surgery at the Emory Ambulatory Surgical Center (ASC).
In this randomized controlled clinical trial patients with diabetes will be administered corrective doses of IV regular insulin or SC humalog for preoperative hyperglycemia to determine whether SC humalog results in improved intra and post-operative blood sugar control.The most common current practice at Emory University in the ambulatory surgical setting is IV administration of regular insulin for treatment of pre-operative hyperglycemia. Subjects will not be paid for their participation and will be assured of treatment for their hyperglycemia regardless of study participation.
详细描述
Investigators plan to randomize a total of 200 male and female subjects with type 1 and type 2 diabetes,having an out patient surgical procedure, meeting inclusion criteria to receive corrective doses of IV regular insulin (Group I) or SC humalog insulin (Group II). The dosing formula is per Emory University Outpatient Surgical Center protocol for treating hyperglycemia and is the same for both groups. All patients with diabetes will undergo a blood sugar measurement upon arrival to the ASC using the Accuchek blood glucose meter. An admission blood sugar of >180 in a patient with diabetes qualifies the patient for study screening. Subjects will be approached after confirmation of eligibility for the study. Randomization, then treatment, will occur immediately following written informed consent. Demographic data will be recorded.A medical history with detailed history of diabetes will be obtained and surgical and anesthesia details and length of stay recorded. Blood sugar levels will be checked hourly until the patient is ready for discharge. Subsequent treatment will follow the hyperglycemia protocol. All blood sugar results and doses of insulin will be recorded. The subject's participation will end at the time of discharge from the Ambulatory Surgical Center.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients between the ages of 18 and 80 years with type 1 and type 2 diabetes
- •patients undergoing ambulatory surgery
- •a known history of diabetes for > 3 months treated with diet, oral antidiabetic agents and/or insulin therapy
- •subjects with an admission/randomization Blood glucose> 180 and < 400 mg/dl
- •Patients willing and able to provide informed consent
排除标准
- •Age < 18 or > 80
- •Subjects with increased blood glucose concentration, but without a history of diabetes (stress hyperglycemia)
- •Patients on an insulin pump
- •Patients with a history of clinically significant hepatic disease (cirrhosis, jaundice, end-stage liver disease, portal hypertension) and end- stage renal disease
- •Current or recent (within 3 months) treatment with oral or injectable corticosteroid, parenteral nutrition and immunosuppressive treatment
- •Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
- •Female subjects whom are pregnant or breast-feeding at time of qualifying outpatient procedure
研究组 & 干预措施
Group 1-Regular Insulin
Intravenous Regular Insulin will be administered for a preoperative Blood glucose of greater than 180.
干预措施: Regular Insulin (Drug)
Group 2-Humalog
Subcutaneous Humalog will be administered for a preoperative Blood glucose of greater than 180
干预措施: Humalog (Drug)
结局指标
主要结局
BG concentration differences at 1 and 2 hours post intervention and post operatively
时间窗: one and two hours post intervention, post operative period
Compare the difference in Blood glucose concentration at one and two hours after the administration of corrective doses of regular and humalog insulin and immediately following ambulatory surgery.
次要结局
- Episodes of hypoglycemia(time of intervention to time of patient discharge (an average of three hours, less than one day))
- Number and percentage of target BG readings(From time of treatment until patient discharge (an average of three hours, less than one day))
- Episodes of hyperglycemia(time of treatment to time of patient discharge (an average of three hours, less than one day))
- Total dose of insulin(time of intervention to time of patient discharge (an average of three hours, less than one day))
- Change in glucose concentration from baseline to one, two and three hours post treatment(time of baseline BG to time of last BG measurement (prior to discharge, less than one day))
- Number of perioperative complications(start of surgery to time of patient discharge (less than one day))
研究者
Karen Carlson, MD
Study Principal Investigator
Emory University