Effect of Simplified Insulin Regimen on Glycemic Control and Quality of Life in an Elderly Population With Type 2 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Hemoglobin A1c (HbA1c)
研究概览
简要总结
Basal-bolus insulin therapy, which includes one injection of long acting insulin and three injections of short acting insulin is the most commonly used insulin treatment. However, many older patients find the basal-bolus insulin regimen hard to manage because it involves 4 injections and 4 blood glucose tests each day. It is possible that a simplified treatment that involves one injection of long acting insulin daily and two blood glucose tests daily might be equally effective. This simplified regimen, if effective, would be easier to use and might result in less errors. Therefore, the investigators want to conduct this study to compare using a single daily injection of basal insulin with the usual basal-bolus insulin regimen in elderly patients (age >65 years) with type 2 diabetes.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >65 years
排除标准
- •Unable to provide informed consent
- •Enrollment in another research study
- •History of hypoglycemia unawareness
- •Pregnant women
- •Prisoners
研究组 & 干预措施
Multiple Subcutaneous Injection (MSI)
MSI group will receive four insulin injections per day that will include a long acting and a short acting insulin. Short acting insulin will be either insulin aspart or insulin lispro.
干预措施: Insulin Glargine (Drug)
Multiple Subcutaneous Injection (MSI)
MSI group will receive four insulin injections per day that will include a long acting and a short acting insulin. Short acting insulin will be either insulin aspart or insulin lispro.
干预措施: Insulin Aspart (Drug)
Multiple Subcutaneous Injection (MSI)
MSI group will receive four insulin injections per day that will include a long acting and a short acting insulin. Short acting insulin will be either insulin aspart or insulin lispro.
干预措施: Insulin Lispro (Drug)
Basal Insulin (BI)
BI group will receive only one injection of insulin glargine in the morning.
干预措施: Insulin Glargine (Drug)
结局指标
主要结局
Hemoglobin A1c (HbA1c)
时间窗: 6 months
The mean HbA1c in the BI group will be compared to the mean HbA1c in the MSI group
次要结局
- Incidence of Any Hypoglycemia(6 months)
- Incidence of Severe Hypoglycemia(6 months)
研究者
Rajesh Garg
Professor
University of Miami