A Study of the Rules for Insulin Dosing in Patients Using Multiple Daily Injections
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Determine the mean value for the slop between the variables of total daily dose versus total basal dose.
研究概览
简要总结
This study will be conducted in subjects with Type 1 diabetes mellitus on multiple daily insulin injections to determine the correct insulin dosing formulas. Subjects will be evaluated using continuous glucose monitoring.
详细描述
Subjects with stable type 1 diabetes mellitus on multiple daily insulin injections including basal and bolus will be selected in order to determine the correct insulin dosing formulas. Subjects will be placed on continuous glucose sensor (CGMS) and an isocaloric diet. Subjects will have the CGMS downloaded daily and the insulin doses adjusted if necessary. Subject will do four SMBGs daily to calibrate CGMS and on last day a 7-point SMBG. subjects will be on lispro and glargine insulin. Basal insulin will be once a day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Age: >17 years
- •Type 1 diabetes
- •Diabetes duration > 3 months
- •On treatment with multiple daily injections either one or more basal insulin injections each day for 6 weeks
- •HbA1c <9.0%
- •Stable HbA1c in the proceeding 3 months (i.e., change <1%)
- •Demonstrated adherence to visits and instructions
- •Attend a class in meal carbohydrate content estimation or have demonstrated knowledge of carbohydrate counting
排除标准
- •Major stress event during or for 6 weeks before the evaluation
- •Taking a medication that can alter insulin sensitivity
- •Within one week of menses
- •Unstable eating or activity pattern
- •Pregnancy
- •Weight gain of > 1.5 kg during the preceding 3 months
- •Serum creatinine of >1.5 mg/dl
- •Active liver disease
- •Evidence of autonomic neuropathy, especially gastroparesis
- •Any antidiabetic medication other than insulin
- •Treatment with continuous subcutaneous insulin infusion
结局指标
主要结局
Determine the mean value for the slop between the variables of total daily dose versus total basal dose.
时间窗: Two weeks
次要结局
- Determine the slope between the other variables: weight, total daily dose, total basal dose, insulin correction carbohydrate rate, correction factor(Two weeks)