Comparison of Carbohydrate Counting and Food Insulin Index Methods in the Determination of Insulin Doses for High- and Low-Glycemic Index Meals in Adolescents With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Postprandial glucose response by glucometer
研究概览
简要总结
The aim of this study is to compare the impact of carbohydrate counting (CC) method which is standard insulin dose calculation algorithm and food insulin index (FII) method which is a new algorithm on postprandial glucose following a high fat and a high protein meal in adolescent with type 1 diabetes. A randomized, single-blind and crossover trial included 14 adolescents aged 14-18 years with type 1 diabetes. All participants were sent to their homes for 4 consecutive days with a different glycemic index breakfast. The insulin doses of the meals were calculated according to CC and FII methods. Test breakfasts with different GIs and insulin requirements calculated with different algorithms are as follows: High GI calculated by CC (CHGI), low GI calculated by CC (CLGI), high GI calculated by FII (FHGI) and low GI calculated by FII (FLGI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 14 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 14-18 years adolescents
- •Type 1 diabetes diagnosed for at least one year
- •Performing self-monitoring of blood glucose and doses of insulin at least four times daily
- •HbA1c ≤ 9.6% for the last three months
- •Negative fasting C-peptide (<0.1 nmol/L)
- •Total daily insulin use of ≥ 0.5 U/kg
- •World Health Organization BMI/age z-score of -1 to below 3
排除标准
- •Complications of diabetes or other medical conditions including celiac disease
- •Treatment with oral hypoglycaemic agents
- •Food allergies, intolerances, or eating disorder
- •Intestinal malabsorptions
- •Delayed gastric emptying
- •Viral or bacterial infection
- •Physical or mental disability
- •Clinical condition related to impaired digestive system such as cystic fibrosis
结局指标
主要结局
Postprandial glucose response by glucometer
时间窗: Four hours postprandial period (from fasting to 240 minutes after the test breakfast)
Postprandial glucose response was quantified as incremental area under the curve (iAUC) (mg/dL x minutes), which was calculated according to the trapezoidal rule by using blood glucose values at time points 0, 30, 60, 90, 120, 150, 180, 210 and 240 minutes.
Postprandial glucose response by continous glucose monitoring
时间窗: Four hours postprandial period (from fasting to 240 minutes after the test breakfast)
Postprandial glucose response was quantified as incremental area under the curve (iAUC) (mg/dL x minutes), which was calculated according to the trapezoidal rule by using blood glucose values at time points 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 105, 110, 115, 120, 125, 130, 135, 140, 145, 150, 155, 160, 165, 170, 175, 180, 185, 190, 195, 200, 205, 210, 215, 220, 225, 230, 235 and 240 minutes.
次要结局
未报告次要终点
研究者
Zeynep Caferoglu, PhD
Assistant Professor Doctor
TC Erciyes University