Premix 70/30 Insulin Plus Supplemental Lunch Insulin in Comparison to Basal Plus Prandial Supplemental Scale and Sliding Scale Insulin in Hospitalized Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Mean Daily Blood Glucose (BG) Concentration During Their Hospital Stay.
研究概览
简要总结
Purpose: To compare efficacy and safety of traditional sliding scale insulin (SSI) versus modified 70/30 insulin versus modified basal plus supplemental scale /bolus insulin regimens for glycemic control in hospitalized diabetic patients with diabetes.
Methods: In a prospective trial, patients with diabetes will be randomized to receive either traditional hospital SSI , or twice daily 70/30 insulin plus supplemental lunchtime insulin for BG ≥ 150 mg/dL or once every night glargine plus three times prandial glulisine for BG ≥ 150 mg/dL . 70/30 insulin and glargine will be started respectively at 0.4 and 0.2 U/kg/day for BG ≤ 200 mg/dL or 0.5 and 0.3 U/kg/day for BG above 200 mg/dL.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •known history of type 2 DM for longer than 3 months
- •age between 18-64 year old,
- •treatment with diet alone, any combination of oral antidiabetic agents and/or insulin before admission.
排除标准
- •subjects with hyperglycemia without any known history of DM
- •presence of diabetic ketoacidosis (DKA)
- •patients admitted to intensive care unit (ICU)
- •subjects expected to undergo surgery during the hospitalization course
- •patients with clinically relevant hepatic disease impaired renal function (serum creatinine ≥ 3.0 mg/dL) systemic infections pregnancy patients on medications known to interfere with the blood glucose level (either increasing or decreasing
研究组 & 干预措施
glargine plus supplemental glulisine
Patients who will be recruited to be treated with glargine/glulisine, will received 50% of TDD as detailed demonstrated in Umpierrez et al., studies . as This includes administration of glargine (Lantus®) once every night plus glulisine (Apidra®) before each meal for BG ≥ 150 mg/dL. Glargine dose will be calculated as 0.2 U/kg/day for admission BG less than 200 mg/dL or 0.3 U/kg/day for BG exceeding 200 mg/dL. Glargine was given using Solostar Flex-Pen® once daily in the evening around 8:00 pm. Glulisine was given using the Solostar Flex-Pen® three times just before the meals for BG > 150 mg/dL according to hospital sliding scale. To avoid hypoglycemia, if for any reason, a subject missed a meal, the dose of glulisine will be held.
干预措施: Glargine (Drug)
glargine plus supplemental glulisine
Patients who will be recruited to be treated with glargine/glulisine, will received 50% of TDD as detailed demonstrated in Umpierrez et al., studies . as This includes administration of glargine (Lantus®) once every night plus glulisine (Apidra®) before each meal for BG ≥ 150 mg/dL. Glargine dose will be calculated as 0.2 U/kg/day for admission BG less than 200 mg/dL or 0.3 U/kg/day for BG exceeding 200 mg/dL. Glargine was given using Solostar Flex-Pen® once daily in the evening around 8:00 pm. Glulisine was given using the Solostar Flex-Pen® three times just before the meals for BG > 150 mg/dL according to hospital sliding scale. To avoid hypoglycemia, if for any reason, a subject missed a meal, the dose of glulisine will be held.
干预措施: glulisine (Drug)
70/30 insulin plus supplemental lunch insulin
Modified split-mixed insulin protocol adopted by Umpierrez et al., will be applied to patients treated with 70/30 insulin. Insulin dose will be started at 0.4 U/kg/day for admission BG less than 200 mg/dL or 0.5 U/kg/day for BG above 200 mg/dL. Two thirds of total daily dose (TDD)will be given before breakfast and 1/3 of TDD before dinner. Supplemental lunchtime regular insulin dose will given for BG > 150 mg/dL . Patients previously treated with 70/30 insulin before admission initially will receivethe same regimen as at in home.
干预措施: regular insulin (Drug)
70/30 insulin plus supplemental lunch insulin
Modified split-mixed insulin protocol adopted by Umpierrez et al., will be applied to patients treated with 70/30 insulin. Insulin dose will be started at 0.4 U/kg/day for admission BG less than 200 mg/dL or 0.5 U/kg/day for BG above 200 mg/dL. Two thirds of total daily dose (TDD)will be given before breakfast and 1/3 of TDD before dinner. Supplemental lunchtime regular insulin dose will given for BG > 150 mg/dL . Patients previously treated with 70/30 insulin before admission initially will receivethe same regimen as at in home.
干预措施: 70/30 insulin (Drug)
Sliding Scale insulin (SSI)
For SSI group, regular insulin will be administered three times daily subcutaneously approximately 30 min before meal for BG > 150 mg/dL (or every 8 hours if a patient was not eating) according to hospital sliding scale table
干预措施: regular insulin (Drug)
结局指标
主要结局
Mean Daily Blood Glucose (BG) Concentration During Their Hospital Stay.
时间窗: during hospital stay which is expected to be average 3 weeks
Mean BG After First Day of Hospitalization
时间窗: after first day of hospitalization
次要结局
- Mortality Rate(during the hospital stay which is expected to be average 3 weeks)
- Number of Patients Developed Hypoglycemic Events(during hospital stay which is expected to be average 3 weeks)
- Number of Patients Developed Episodes of Severe Hyperglycemia(during hospital stay which is expected to be average 3 weeks)
研究者
Eman Said
Teaching Assistant, Cairo University
Cairo University