Prandial Insulin Dosing Using the Carbohydrate Counting Technique in Hospitalized Patients With Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Mean Glucose
研究概览
简要总结
The purpose of this study is to determine whether mealtime insulin results in better control of blood sugar than a fixed meal dose in hospitalized patients.
详细描述
The purpose of this study is to determine whether mealtime insulin, dosed to match the intake of carbohydrates (starches or sugars) results in better control of blood sugar than a fixed meal dose in hospitalized patients.
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
- •general medical or minor surgical hospitalized patients
- •type 2 diabetes
- •blood glucose 150-400 on at least 2 occasions within 24 hours or requiring at least 20 units of insulin/day in the 24 hours prior to enrollment
排除标准
- •• Major surgery, occurring within the previous 2 weeks or planned within 72 hours of study entry, including cardiothoracic, neurosurgical, and open intra-abdominal procedures (in particular, any surgery lasting over 2 hours).
- •Patients receiving glucocorticoids, total parental nutrition (TPN), or tube feeds.
- •Pregnancy (glucose targets differ in pregnancy). Premenopausal women not on pharmacologic contraceptives, inrauterine device (IUD), or surgical menopause will undergo pregnancy testing.
- •Patients currently on IV insulin (must wait to enroll) or with planned surgical procedures in the next 72 hours for whom intravenous insulin will be likely
- •Prolonged (>24 hour) strict nil per os (NPO-nothing by mouth) status (eg. small bowl obstruction). Liquid or modified consistency diets are acceptable.
- •Patients for whom expected length of stay will be less than 48 hours
- •Patients using subcutaneous insulin pumps
- •Diabetic ketoacidosis
- •End-stage renal disease on dialysis
- •End-stage liver disease with cirrhosis
- •Mental conditions precluding informed consent
- •Potentially sensitive admissions: prisoners, HIV, suicidality
- •Unable to give consent in English
研究组 & 干预措施
Aspart flexible dose
aspart dose determined based upon carbohydrate intake.
干预措施: Aspart flexible dose (Drug)
Aspart fixed dose
fixed meal dose of aspart (based upon weight or total daily insulin dose)
干预措施: Aspart fixed dose (Drug)
结局指标
主要结局
Mean Glucose
时间窗: day 3
Mean glucose was calculated per participant from the average of glucose values over the 7-point (pre- and post-breakfast, lunch, dinner, and bed) glucose profile at day 3
次要结局
- Change in Glucose(72 hour)
- Postprandial Glucose(day 3)
- Hypoglycemia(72 hour)
- Treatment Satisfaction(day 3)
- 1,5-anhydroglucitol Change(day 1 to day 3)
研究者
Kathleen Dungan
Assistant Professor
Ohio State University