Comparison of Two Biphasic Insulin Regimens in Well-controlled Patients With the Use of Continuous Glucose Monitoring and New Glycemic Control Indices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 主要终点
- Change in average blood glucose
研究概览
简要总结
Comparison of Two Biphasic Insulin Regimens in Well-controlled Patients With the Use of Continuous Glucose Monitoring and New Glycemic Control Indices
详细描述
A cross-over study of 36 well controlled people with type 2 Diabetes Mellitus who underwent 7-day Continuous Glucose Monitoring with Premixed Human Insulin 30/70 and subsequently with Biphasic Aspart 30.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 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
- 否
入选标准
- •regular attendees of Outpatient Clinic of the Diabetes Centre of the 1st Department of Internal Medicine of University Hospital in Thessaloniki Greece
- •The patients were on Premixed Human Insulin 30/70 twice daily with or without metformin
- •baseline HbA1c<7%
排除标准
- •the presence of type 1 Diabetes Mellitus
- •stage 4 Chronic Kidney Disease
- •use of antidiabetic medications other than insulin and metformin
- •major cardiovascular event during the last six months
- •acute illness and hospitalization during the last two weeks
- •pregnancy
- •absence of good metabolic control assessed with self-monitoring of blood glucose during the week before entering the study (>20% of the measurements <80mg/dl or >130mg/dl)
- •inability of the patients to understand the study procedures and sign the consent form
研究组 & 干预措施
Premixed Insulin
Premixed Human Insulin
干预措施: Premixed Human Isophane Insulin Suspension + Human Insulin Injection (Drug)
Premixed Insulin
Premixed Human Insulin
干预措施: Premixed Insulin (Drug)
Premixed insulin
Premixed Insulin Analog
干预措施: Premixed Human Isophane Insulin Suspension + Human Insulin Injection (Drug)
Premixed insulin
Premixed Insulin Analog
干预措施: Premixed Insulin (Drug)
结局指标
主要结局
Change in average blood glucose
时间窗: 7 days
average blood glucose (mg/dl) from continuous glucose monitoring
Glycated Albumin
时间窗: 7 days
levels of glycated albumin (%) in serum
Fructosamine
时间窗: 7 days
levels of fructosamine (μmol/L) in serum
次要结局
- Daily Insulin requirements(7 days)
- nocturnal average blood glucose(7 days)
- Time in range(7 days)
- time above 180(7 days)
- time below 70(7 days)
研究者
Prof. Triantafyllos Didangelos
Associate Professor of Internal Medicine-Diabetology
Aristotle University Of Thessaloniki