NCT07455643

Closed-loop Response to Unannounced Mixed and Carbohydrates-rich Breakfasts

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Catania · Academic / Other
• Sex: All
• Age: 11 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
OTHER	Unannounced meal	Participants consumed both the "CHO meal" and the "mixed meal" three times each, 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.

Timeline

• Start date: 2025-04-20
• Primary completion: 2025-05-20
• Completion: 2025-05-20
• First posted: 2026-03-06
• Last updated: 2026-03-06

Locations

1 site across 1 country: Italy