"Fake Carbs" Practice in the Glycemic Outcomes in Children and Adolescents Using AID System: A Cross-over Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Change in Time in Tight Range
研究概览
简要总结
Hybrid Closed Loop (HCL) systems, such as the MiniMed 780G, have significantly improved glycemic outcomes in Type 1 Diabetes (T1D) management. The MiniMed 780G, an Advanced Hybrid Closed Loop (AHCL) system, features autocorrection boluses and unique insulin adjustment technologies. While effective, the system requires user input for meal announcements. Some individuals attempt to "trick" the system by entering "fake carbs" to prompt additional insulin corrections. However, clinical evidence suggests this practice does not improve glycemic outcomes.
This study, conducted in Athens, Greece, will involve 40 children and adolescents (ages 7-18) with Type 1 Diabetes who have been using the MiniMed 780G system for over 6 months. The open-label, crossover design explores the impact of 'fake carbohydrates' on glycemic control. Participants will be split into two groups: one starts with 'fake carbohydrates' and then stops, while the other does the reverse. Over two weeks, their glycemic outcomes will be monitored and compared, with exclusions for severe diabetes complications or serious diabetic events
This study hypothesizes that using "fake carbs" does not enhance glycemic control. Findings are expected to provide evidence-based insights to optimize diabetes management and improve clinical guidance for HCL system users.
详细描述
Aim of the Study To compare glycemic control outcomes in individuals with T1D using the MiniMed™ 780G system during periods when 'fake carbohydrates' are used versus periods when this strategy is not employed.
Definition: Fake Carbohydrates As a Fake Carbs practice is defined the practice when the user enters fake quantity of carbohydrates in order to trigger the system to suggest and deliver a bolus insulin with the aim to correct hyperglycemia.
Study Design and Participants This is a prospective, open-label, randomized, crossover trial conducted at the Diabetes Center of the General Hospital "P. & A. Kyriakou" in Athens, Greece.
Sample Size
- Total Participants: 40 children and adolescents
- Age Range: 7-18 years Inclusion Criteria
- Diagnosis of T1D
- Using the MiniMed™ 780G system for ≥6 months
- Habitual use of fake carbohydrates in daily management Exclusion Criteria
- Severe diabetes-related complications
- Recent episodes of diabetic ketoacidosis (DKA) or severe hypoglycemia Randomization and Group Allocation
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 7 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged 7-18 years
- •T1D >6 months
- •on MiniMed 780G system in automode.
排除标准
- •Participants with significant diabetes complications
- •Participants with severe episode of diabetic ketoacidosis in the last 6 months
- •Participants with hypoglycemia in the last 6 months.
结局指标
主要结局
Change in Time in Tight Range
时间窗: 2 weeks
Change between groups in time in blood glucose in Tight Range -TITR ( defined as 70-140 mg/dl) (%)
Change in Time In Range
时间窗: 2 weeks
Change between groups in blood glucose in Time in Range -TIR ( defined as 70-180 mg/dl) (%)
Change in Time Below Range
时间窗: 2 weeks
Change between groups in blood glucose in Time Below Range- TBR (defined as \<54mg/dl) (%)
次要结局
- Changes in insulin Auto-correction(2 weeks)
- Changes in insulin Manual bolus(2 weeks)
- Changes in number of severe hypoglycemia episodes(2 weeks)
- Changes between groups in GMI(2 weeks)
- Changes in Time Above Range(2 weeks)
- Change in mean sensor glucose(2 weeks)
- Change in Standard Deviation of glucose(2 weeks)
- Changes in Coefficient of Variation for glucose(2 weeks)
- Changes in number of announced carbs(2 weeks)
- Changes in total daily insulin dose(2 weeks)
- Changes in insulin Auto-basal rate(2 weeks)
- Changes in the number of diabetic ketoacidosis (DKA) events(2 weeks)
研究者
Maria Chatzipsalti
Pediatrician and Pediatric Endocrinologist-Diabetologist
Athens General Children's Hospital "Pan. & Aglaia Kyriakou"