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临床试验/NCT03179280
NCT03179280已完成不适用

Effect of Dual-wave Insulin Bolus on Postprandial Glycaemia According to the Composition of the Meal in Adolescents With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion

Aristotle University Of Thessaloniki1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2011年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
post-prandial euglycaemia (PPG)

研究概览

简要总结

A study was conducted in adolescents with type 1 diabetes (T1D) examining the effect of different bolus types on 6-h postprandial glucose levels after the consumption of 3 standard meals with varying composition. Participants were asked to consume 10 different combinations of meal and bolus type.

详细描述

The nutritional recommendations of children and adolescents with T1D should be similar to those of healthy people in order to achieve the desirable growth. Not only the carbohydrates' intake is underlined according to special guidelines by Canadian diabetes association, American diabetes association and International Society for Paediatric and Adolescent Diabetes but also proteins and fats are suggested to be taken into consideration in the management of T1D. In order to reach the desirable euglycemic control, children and adolescents can use multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII). By using the CSII the insulin can be administrated in three different patterns; as a normal bolus, as a dual wave bolus and as a square wave bolus. Dual wave insulin bolus (D/WB) is suggested as the most suitable option based on the effects that is having after meals with different content of carbohydrates, fats and proteins. The aim of this study was to evaluate the impact of different types of D/WB on PPG after 3 given meals, in adolescents with T1D on CSII. In order to achieve that, 3 different meals were designed and combined with alternative types of boluses, D/WB and square wave insulin bolus (S/WB).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
11 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • duration of T1D >3 years, CSII therapy for at least 1 year, good to moderate glycaemic control, as evidenced by HbA1c levels <8.5% (69 mmol/mol).

排除标准

  • Subjects with eating disorders, food allergy, celiac disease and known diabetic complications

研究组 & 干预措施

Adolescents with T1D on CSII

Active Comparator

3 standard meals with varying composition were consumed and combined with alternative types of D/WB and S/WB All participants used the rapid-acting insulin analogue aspart (NovoRapid®, Novonordisk A/S, Bagsvaerd, Denmark) and total insulin dose administered to each one for each test meal was known in advance, according to the insulin to carbohydrate ratio that had been calculated during the 2-week pre-study period.

干预措施: insulin (Drug)

结局指标

主要结局

post-prandial euglycaemia (PPG)

时间窗: 3 days

the impact of different types of D/WB on PPG after three given meals, in adolescents with T1D on CSII. In order to achieve that, three different meals were designed and combined with alternative types of boluses, D/WB and S/WB

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Assimina Galli-Tsinopoulou

Associate Professor, 4th Department of Pediatrics, Medical School of Aristotle University of Thessaloniki

Aristotle University Of Thessaloniki

研究点 (1)

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