NCT01050868已完成不适用
Comparison of the Management of Post-prandial Hyperglycemia by Multiple Bolus Calculators
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To compare the difference between the self-monitoring blood glucose (SMBG) value achieved at 6 hours after meals with induced post-prandial hyperglycemia and the mean target value of 110 mg/dL. Target post-prandial range is 80-140 mg/dL.
研究概览
简要总结
This prospective, non-randomized, non-controlled, interventional study will determine whether the Roche automated bolus caclulator (ABC) reduces post-meal hyperglycemia better than the competitor's ABC without causing significant hypoglycemia.
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
- Diagnostic
- 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
- •Subjects >/= 18 years at screening
- •Type 1 diabetics currently using an insulin pump for management of their diabetes and have been on a pump for at least at least 6 months prior to the screening visit
- •Subjects have to use a fast acting analog insulin
- •HbA1c = 9% (measured with DCA 2000)
- •Willing to perform periods of intensive blood glucose (BG) monitoring for up to 21 days prior to the study (~10 tests per day) with skipped meals and testmeals
- •Willing to use the 3 different bolus calculators during the course of the study
- •Willing to undergo planned hyperglycemia
- •Willing to perform high frequency BG monitoring (> 20 / day) during the experiment
排除标准
- •Type 2 Diabetes
- •Manifest severe late complications of diabetes (e.g. severe macro- or microangiopathy, severe neuropathy, severe retinopathy and/or severe nephropathy)
- •Current addiction to alcohol or substances of abuse
- •Pregnant or lactating women
- •Any known life-threatening disease
研究组 & 干预措施
Single Arm
Experimental
干预措施: Accu-Chek Combo Kit mg DE/de (Device)
结局指标
主要结局
To compare the difference between the self-monitoring blood glucose (SMBG) value achieved at 6 hours after meals with induced post-prandial hyperglycemia and the mean target value of 110 mg/dL. Target post-prandial range is 80-140 mg/dL.
时间窗: 6 hours after meal
次要结局
- To compare the absolute difference between the SMBG value and the target value between the calculators(6 hours after meal)
- To compare theto compare the relative difference (multiplied by 100) between the SMBG value and the target value between the calculators(6 hours after meal)
- To compare the absolute relative difference (RAD, multiplied by 100) between the SMBG value and the target value between the calculators(6 hours after meal)
研究者
研究点 (1)
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