NCT05866900

The Impact of Daily Carbohydrate Intake on Glycemic Control in Children and Adolescents With Type 1 Diabetes Using an Advanced Hybrid Closed-loop System

The Impact of Daily CarboHydrate Intake on Glycemic Control in Children and Adolescents With Type 1 Diabetes Using an Advanced Hybrid Closed-loop System (Medtronic MiniMed 780G): a Multi-center Real-world Observational Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: University of Ljubljana, Faculty of Medicine · Academic / Other
• Sex: All
• Age: 7 Years – 18 Years
• Healthy volunteers: —

Summary

Lifestyle factors, including diet, play an important role in the achievement of glycemic targets in patients with diabetes, even with the use of automated insulin delivery (AID) systems. Advanced hybrid closed-loop systems (AHCL), by implementing innovative and powerful control algorithms, have been shown to improve the post-meal glycemic control in their users through the delivery of automatic correction boluses. However, data about the influence of the daily amount of carbohydrate intake on glycemic outcomes in youth with type 1 diabetes using AHCL are missing. Therefore, this study will evaluate the association between daily carbohydrate intakes and meal patterns on glycemic control of young people living with type 1 diabetes using an AHCL system (Medtronic MiniMed 780G; Medtronic, Northridge, California) under real-life conditions.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DEVICE	MiniMed 780G with SmartGuard activated	The MiniMed 780G system consists of a MiniMed 780G Insulin Pump connected to Guardian 4 Sensor or Guardian 3 Sensor, using an automated insulin delivery algorithm called SmartGuard.

Timeline

• Start date: 2023-05-15
• Primary completion: 2023-08-31
• Completion: 2023-10-31
• First posted: 2023-05-19
• Last updated: 2023-05-19

Regulatory

• FDA-regulated device study