The CRUMB Study: Closed-loop Response to Unannounced Mixed and Carbohydrates-rich Breakfasts. A Randomized Controlled Crossover Pilot-study in a Cohort of Adolescents With Type 1 Diabetes.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in blood glucose concentration from pre-meal to two hours post-meal (2h-ΔBG), as measured by CGM in mg/dl
研究概览
简要总结
The development of advanced hybrid closed-loop (a-HCL) systems represents a significant step toward in improving glucose control and reducing user-dependent variability, especially In pediatric patients. Systems can automatically deliver correction boluses and modulate insulin delivery based on CGM feedback, thereby compensating for some of the consequences of human error. Current evidence suggests that a-HCL systems can tolerate unannounced carbohydrate loads up to approximately 20 g without compromising time in range (TIR) or safety. However, the metabolic response to larger or compositionally complex meals remains variable and highly dependent on the specific algorithm governing insulin delivery.
Currently a variety of AID are commercially available: all of them present similarities and differences. The Medtronic MiniMed™ 780G uses a proportional-integral-derivative (PID) algorithm, a mathematical model that adjusts in real time insulin delivery rate based on 3 elements obtained from CGM reading values: the difference between the actual value and the chosen glucose target (proportional action), past values (integral action) and the glucose's rate of change (derivative action), In contrast, the Tandem t:slim X2™ with Control-IQ employs a model predictive control (MPC) algorithm, which aims, through a complex mathematical model, to predict glucose trends up to half-an-hour in the future, takin, also, in consideration actual and past glucose values. Despite sharing the same objective, said algorithms have different approaches, the former one being "reactive" and the latter "predictive". Therefore, their difference could result in different performances while facing mixed-nutrient meal or unannounced meals, defined as the consumptions of a meal with any prior insulin administration.
Pediatric patients represent certainly a unique subgroup in which therapeutic adherence is a relevant issue, due to cognitive, developmental and behavioral factors. Understanding how different AID algorithms respond to unannounced meals in this age group is therefore crucial for optimizing safety and personalization of diabetes management.
This study was designed to evaluate the strengths and limitations of two a-HCL systems, the Medtronic 780G (PID algorithm) and the Tandem t:slim X2 (MPC algorithm), in managing unannounced meals with different macronutrient compositions in children and adolescents with T1D. We also aim to better understand physiological and technological unannounced meal implications as to provide additional insight useful for the development of new fully closed loop algorithms, capable of minimizing glucose excursions and patient's burden.
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
- 11 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 11 and 18 years;
- •Type 1 diabetes diagnosed for at least 12 months;
- •Use of an A-HCL device for at least 3 months;
- •Proficiency in carbohydrate counting.
排除标准
- •Presence of malabsorption disorders;
- •Presence of chronic diabetes complications.
研究组 & 干预措施
Announced meal (AM)
Participants followed their usual therapy while consuming both the "CHO meal" and the "mixed meal" three times each. In this phase, the carbohydrate content of each meal was announced to the insulin pump, and pre-meal boluses were delivered as per standard practice.
Unannounced meal (UM)
Participants consumed the same meals, an equal number of times, without announcing their carbohydrate intake to the device. Consequently, no user-initiated boluses were administered during this period, and all insulin delivery adjustments were determined exclusively by the algorithm.
干预措施: Unannounced meal (Other)
结局指标
主要结局
Change in blood glucose concentration from pre-meal to two hours post-meal (2h-ΔBG), as measured by CGM in mg/dl
时间窗: from pre-meal to two hours post-meal
Change in blood glucose concentration from pre-meal to two hours post-meal (2h-ΔBG), as measured by CGM
次要结局
- Pre- and post-meal four-hour glucose difference (4h-ΔBG), as measured by CGM in mg/dl(from pre-meal to four hour postprandial)
- Peak CGM value in mg/dl(from pre-meal to four hour postprandial)
- Time to peak CGM value(from pre-meal to four hour postprandial)
- Percentage of spent time in range (TIR, 70-180 mg/dL), as measured by CGM(from pre-meal to four hour postprandial)
- Percentage of spent time in tight range (TITR, 70-140 mg/dL), as measured by CGM(from pre-meal to four hour postprandial)
- Percentage of spent time below range (TBR, < 70 mg/dL), as measured by CGM(from pre-meal to four hour postprandial)
- Percentage of spent time above range (TAR, > 180 mg/dL), as measured by CGM(from pre-meal to four hour postprandial)
- Percentage of spent time in second-level TAR (> 250 mg/dL), as measured by CGM(from pre-meal to four hour postprandial)
研究者
Laura Sciacca
Associate Professor
University of Catania