Role of Insulin Aspart and Detemir to Assess Glucose Excursion in Children With Type 1 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Assess the Mean Area Under the Curve (AUC) for Blood Glucose Concentration in Subjects Treated With Either Insulin Detemir Mixed With Rapid Acting Insulin (RAI) or Insulin Detemir and RAI as Separate Subcutaneous Injections
研究概览
简要总结
Study of blood sugars in the children with Type 1 Diabetes Mellitus (T1DM), who are given insulin detemir and a rapid acting insulin (aspart). It is hypothesized that there is no difference in the patterns of blood sugars when detemir is given in the same syringe or in separate syringes with rapid acting insulin.
详细描述
One of the barriers to good glycemic control in children with type 1 diabetes is multiple daily insulin injections. Mixing rapid-acting (detemir) and slow- acting insulins (aspart) in the same syringe would decrease the number of injections and may improve adherence
This study hypothesized that slow-acting insulin detemir mixed with aspart would have equivalent effects on blood glucose versus giving them as separate injections in children with type 1 diabetes.
Eighteen pediatric subjects with type 1 diabetes (11 males and 7 females) were recruited. However only 14 subjects completed this 20-day, randomized, crossover, and open-labeled study. The subjects were randomly assigned to either Study A (both insulin detemir and rapid acting insulin (RAI)) or Study B (either detemir or aspart) for the first 10 days. They were then crossed over for the last 10 days. Each subject underwent 72 h of continuous glucose monitoring (CGM) during the last 72 h, for both Study A and Study B.Data of 48 h from midnight of the 1st day to mid- night of the 3rd day of the 72-h (CGM) were used for analysis to ensure the same starting and ending times of monitoring for all subjects.Sustained glucose values over time were calculated as area under the curve (AUC), index of blood glucose control as M-value and glucose excursion as mean amplitude of glucose excursion (MAGE)
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
- 10 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with antibody positive Type 1 Diabetes Mellitus (T1DM)
- •On insulin glargine for at least 3 months
- •Age 10-25 years
- •Not on medications that may affect glucose concentrations
- •Hemoglobin A1C (HbA1C) of less than 9 %
- •Body Mass Index (BMI) less than 95th % and more than 10th%
- •Supportive family
排除标准
- •Subjects with undetermined diabetes or Type 2 Diabetes Mellitus (T2DM)
- •Unable to adhere to insulin regimen
- •Positive urine pregnancy test
研究组 & 干预措施
Insulin Detemir+RAI, then Insulin Detemir and RAI separately
Participants first received, Insulin Detemir mixed with RAI, twice daily as subcutaneous injection for 10 days. Then they received Insulin Detemir and RAI as separate subcutaneous injections, twice daily for the next 10 days.
干预措施: Insulin Detemir mixed with RAI injection (Drug)
Insulin Detemir and RAI separately, then Insulin Detemir+RAI
Participants first received Insulin Detemir and RAI as separate subcutaneous injections, twice daily for 10 days. Then they received Insulin Detemir mixed with RAI, twice daily as subcutaneous injection for the next 10 days.
干预措施: Insulin Detemir and RAI injection (Drug)
结局指标
主要结局
Assess the Mean Area Under the Curve (AUC) for Blood Glucose Concentration in Subjects Treated With Either Insulin Detemir Mixed With Rapid Acting Insulin (RAI) or Insulin Detemir and RAI as Separate Subcutaneous Injections
时间窗: 0-48 hours post-dose
Blood glucose concentration in terms of mean AUC (0-48 hours)was determined in subjects treated with either Insulin Detemir mixed with RAI or Insulin Detemir and RAI as separate subcutaneous injections.
次要结局
未报告次要终点
研究者
Rubina Heptulla
Principal Investigator
Montefiore Medical Center