Basal/Bolus Insulin Therapy in the Hospital Ward Comparison of Two Protocols: Feasibility Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The rate of correct timing of insulin and food administration
研究概览
简要总结
The purpose of this study is to determine if by using insulin analog (Glargine and lispro insulin) with an insulin pen the investigators are able to obtain a higher rate of correct timing of insulin and food administration as when compared to the usual therapy (insulin NPH and regular) with syringes.
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
- •Uncontrolled blood sugar:
- •Random blood sugar ≥ 200mg/dl
- •Pre-prandial blood sugar greater than 180 mg/dl on two occasions within 24 hours.
- •Patient may be off insulin or on subcutaneous inpatient insulin regimen less than 36 hours.
- •Transition from an Insulin Drip in the intensive care units to subcutaneous insulin upon transfer to general ward.
- •Patient is able to eat and oral feeding is expected.
排除标准
- •Patients receiving inpatient oral hypoglycemic agents
- •Patients with chronic kidney disease stages 4 & 5 (estimated GFR of <30ml/min) and on dialysis
- •Patient with chronic liver disease
- •Patient with hypoglycemia unawareness
- •Pregnancy
- •Patients who are on "NPO" for medical reasons.
- •Patient is expected to stay in the hospital for less than 3 days.
- •Patient on a new inpatient insulin regimen for > 36 hours.
研究组 & 干预措施
2
The active control group will receive twice daily NPH insulin as basal insulin and bolus (prandial) insulin as regular insulin to be administered 30 minutes before meals. The administration of basal (prandial) regular insulin and food will be done as the current usual care on the hospital ward. The protocol for initial insulin dose and subsequent dose adjustment has been developed by the "Inpatient Diabetes Advisory Group" and is detailed in appendix B. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff.
干预措施: NPH insulin and regular insulin (Drug)
1
The study group will receive Insulin Glargine as basal insulin and bolus (prandial) insulin as lispro insulin (choice between pens or vials will be made). The administration of bolus (prandial) insulin pen or syringe will be delivered concurrently with the food tray (the concept of "insulin pen/syringe on the food tray") by the nursing staff that together with hospital food services identifies the food tray for the patients in the study group. The protocol for initial insulin dose and subsequent dose adjustment has been developed by the "Inpatient Diabetes Advisory Group" and is detailed in appendix A. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff
干预措施: Glargine insulin (Drug)
1
The study group will receive Insulin Glargine as basal insulin and bolus (prandial) insulin as lispro insulin (choice between pens or vials will be made). The administration of bolus (prandial) insulin pen or syringe will be delivered concurrently with the food tray (the concept of "insulin pen/syringe on the food tray") by the nursing staff that together with hospital food services identifies the food tray for the patients in the study group. The protocol for initial insulin dose and subsequent dose adjustment has been developed by the "Inpatient Diabetes Advisory Group" and is detailed in appendix A. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff
干预措施: lispro insulin (Drug)
结局指标
主要结局
The rate of correct timing of insulin and food administration
时间窗: Correct time was 30 min before to 30 minutes after meal was given for control group, and 15 minutes before to 15 minutes after in case group
Pre and post- prandial glucose levels
时间窗: Pre prandial glucose levels were obtained from 0 to 15 minutes before meal , post prandial glucose levels were obtained 2 hours after mealtime
次要结局
- Length of hospital stay(Measured 24 hours after patient is dischargerd, from day 1 of admission until day of discharge)
- Nursing staff satisfaction scores for evaluation of the two methods(24 hours after last patient is discharged)
- Hypoglycemia rates.(From day 1 of admission until day of discharge, obtained from capillary blood checks done QAC and 2 hours postprandial)
- High excursions of blood sugars (>300 mg/dl).(From day 1 of admission until day of discharge, obtained from capillary blood checks done QAC and 2 hours postprandial)