A Pilot Study to Explore Basal Insulin Dosing Requirements in Patients With Type 2 Diabetes Treated With Insulin Pump Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- What are the mean number of changes in the basal infusion rate(change is defined as any alternation in the basal rate >0.1 U/hr) and what are the mean differences and mean duration (hrs) of these changes.
研究概览
简要总结
The main purpose of this study is to determine the number of daily basal insulin rate changes that are needed to achieve short-term near normal glucose control in insulin pump patients with type 2 diabetes
详细描述
Subjects will be taught CHO counting after which they will be introduced to an insulin pump. They will wear the insulin pump for three weeks to adjust to the pump and its functions. Then the subject will wear a Continuous Glucose Monitoring System to determine rate changes needed to achieve short-term near normal glucose control. The primary endpoint is what are the mean number of changes in the basal infusion rate and what are the mean differences and mean duration of these changes. The secondary endpoint is what mathematical formulas describe the relationship between the dosing factors and do they significantly differ from those previously established by King and Armstrong.
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
- •Type 2 diabetes > 3month duration
- •Hb A1C <12%
- •On any hypoglycemic therapy including insulin for 5 patients and 5 patients naive to insulin and failing oral treatment
- •Normal creatine
- •Negative for GAD antibodies
- •SMBG >4/d and willing/able to comply with study requirements
- •Demonstrated adherence to visits and instructions.
- •Exclusion Criteria
- •Severe hypoglycemic during the last month
- •Severe cardiac, pulmonary or cerebral disease
- •Demonstrated non compliance with clinical recommendations
- •Pregnancy, nursing or women who could potentially become pregnant
- •Presence of physical, psychological or cognitive impairments that would interfere with adherence to an intensive insulin therapy program or compliance with dietary, diary keeping or maintenance of CGM sensor or pump
排除标准
- 未提供
结局指标
主要结局
What are the mean number of changes in the basal infusion rate(change is defined as any alternation in the basal rate >0.1 U/hr) and what are the mean differences and mean duration (hrs) of these changes.
时间窗: week six of study
次要结局
- What mathematical formulas describe the relationship between the dosing factors and do they significantly differ from those previously established by King and Armstrong(week 6 of study)
研究者
Allen B. King, MD
Principal Investigator
Diabetes Care Center