Evaluation on Glycemic Control Using Two Different Meal Announcement Plans in Adolescents With Type 1 Diabetes on Minimed 780G Hybrid Closed Loop System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Time above Range (>180mg/dl and >250mg/dl)
研究概览
简要总结
Carbohydrate counting is an essential component of diabetes management in both adults and children, and together with an intensive insulin plan and increased blood glucose monitoring was associated with lower HbA1c. Carbohydrate counting is perceived as one of the most burdensome tasks in T1D and is frequently done inconsistently and with poor accuracy A recent analysis confirms that MiniMed™ Advaced Hybrid closed loop (AHCL) system is designed for optimal performance with meal announcement. Nonetheless, when meals containing < 80 grams of carbohydrates are consumed with announcement of meals at will, there is a slight reduction in the number of daily boluses with no decline in glycemic control, yet markedly less diabetes related distress and improved treatment satisfaction TIR of 78.1% in unannounced meals compared with 78.8% with announced meals .
详细描述
We aim to compare glucose control in adolescents with Type 1 Diabetes (T1D) without carbohydrate counting skills that use simplified meal announcement to those with carbohydrate counting skills with regular meal announcement by carbohydrates, both using MiniMed 780G system.
This study is observational, two arm, single-center, clinical investigation in subjects with type 1 diabetes on AHCL insulin pump in a period of 3 months, with extension of another 9 months.
A total of 34 individuals (age 12-17 years) will be enrolled to reach 30 individuals who will complete the 3 months study.
Participants will be assigned in two groups based on score of the Carbohydrate Assessment Tool (appendix):
- Group 1(Flex), Regular Clinical Protocol, 17 participants (Score>7)
- Group 2, (Fix), Simplified Clinical Protocol, 17 participants (Score<4) If the score is between 5-6, another training session for carbohydrate counting will be offered to the participants and assessment will be performed again to assign the participant to the each group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of type 1 diabetes >1 year prior to consent date. Diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not required.
- •Age 12 and above at the initiation of the system
- •Total daily insulin use of great than 8.0 units per day over a 1-week period
- •Willing and able (access to internet from home) to download information into the Medtronic CareLink software
- •Clinically able to start the AHCL system
排除标准
- •Untreated diabetes retinopathy, or other causes that in the investigator's opinion , precludes the individual from participating in the trial.
结局指标
主要结局
Time above Range (>180mg/dl and >250mg/dl)
时间窗: 3 months
Change in %
Time in Range (70-180mg/dl)
时间窗: 3 months
Change in %
Hba1c
时间窗: 3 months
Change in %
Time below Range (<54mg/dl and <70mg/dl)
时间窗: 3 months
Change in %
次要结局
- Severe hypoglycemia(3 months)
- Autocorrection insulin dose(3 months)
- Diabetic Ketoacidosis(3 months)
- Total Daily insulin dose(3 months)
研究者
Goran Petrovski
Senior Attending Physcian, Prof, MD, PhD
Sidra Medicine