Real-world Study on the Effectiveness and Safety of Control-IQ Technology in Teenagers With Type 1 Diabetes Engaging in Regular Physical Activity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Time in range (%)
研究概览
简要总结
We hypothesize that the use of the Control-IQ system positively influences glycemic control in teenagers with type 1 diabetes during physical activity. To test this hypothesis, we will evaluate the glucose profiles (based on CGM metrics) of adolescents engaging in different types, intensities, and durations of physical activity over a 14-day period, in real-life conditions. We will compare glucose control on exercise days with that on sedentary days.
As a secondary objective, we will investigate the influence of factors such as anthropometric characteristics, type and duration of exercise, the use of the exercise mode and other management strategies used for physical activity, on glycemic outcomes.
Regarding the safety, we will report any episodes of severe hypoglycemia or diabetic ketoacidosis (DKA).
This is an observational, open-label, non-randomized, real-world study. Each participant will be provided with a diary to record detailed information about physical activity sessions over a 14-day period, including type, intensity, and duration of exercise, and timing and composition of pre-exercise meals. Clear instructions on how to complete the diary will be provided.
CGM metrics will be analyzed throughout the 14-day observation period, including time in range, time in tight range, time above range, time below range, mean glucose level, and coefficient of variation. A daily comparison will be performed between metrics recorded on days of physical activity and sedentary days, assessing the entire day as well as daytime (07:00-23:00) and nighttime (23:00-07:00) periods.
The influence of factors such as anthropometrics, type of physical activity, the use of the exercise mode and other specific management strategies, type and duration of exercise, and pre-exercise meals on CGM metrics will be evaluated.
The frequency of severe hypoglycemia and DKA episodes, as defined by international guidelines, will be assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 1 diabetes according to International Society for Pediatric and Adolescent Diabetes (ISPAD) guidelines
- •Duration of diabetes > 12 months
- •Age < 20 years
- •Pubertal development completed according to the Tanner stage
- •Use of Control-IQ technology for at least 3 months
- •Automatic mode use for at least 70% of the time during the 2 weeks preceding enrollment
- •CGM use for at least 70% of the time during the 2 weeks preceding enrollment
- •Regular physical activity (at least 2 sessions per week, each lasting at least 45 minutes)
排除标准
- •Uncontrolled celiac disease or thyroid disease
- •Presence of other chronic illnesses
- •Psychiatric or neurological conditions, including eating disorders, that may interfere with the study
- •Chronic use of medications (other than insulin) that may affect glucose control
- •Chronic use of substances or drugs that could impact CGM accuracy
结局指标
主要结局
Time in range (%)
时间窗: 14 days
Time spent with sensor glucose between 70 and 180 mg/dl (3.9 and 10 mmol/L)
Time in tight range (%)
时间窗: 14 days
Time spent with sensor glucose between 70 and 140 mg/dl (3.9 and 7.8 mmol/L)
Time above range level 1 (%)
时间窗: 14 days
Time spent with sensor glucose between 180 and 250 mg/dl (10.1 and 13.9 mmol/L)
Time above range level 2 (%)
时间窗: 14 days
Time spent with sensor glucose \> 250 mg/dl (13.9 mmol/L)
Time below range level 1 (%)
时间窗: 14 days
Time spent with sensor glucose between 54 and 70 mg/dl (3.0 and 3.8 mmol/L)
Time below range level 2 (%)
时间窗: 14 days
Time spent with sensor glucose \< 54 mg/dl (3.0 mmol/L)
Mean sensor glucose (mg/dl or mmol/L)
时间窗: 14 days
Coefficient of variation (%)
时间窗: 14 days
次要结局
- Daytime (h 07.00-23.00) Time in Range (%)(14 days)
- Nighttime (h 23.00 - 07.00) Time in Range (%)(14 days)
研究者
Bruno Bombaci
MD
University of Messina