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

University of Ljubljana, Faculty of Medicine

Status: Not yet enrolling

Conditions: Diabetes Mellitus, Type 1

Treatments: Device: MiniMed 780G with SmartGuard activated

Study type: Observational

Funder types: Other

Identifiers

NCT05866900

CHOco-AID

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 7 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with type 1 diabetes
• Patients aged 7-18 years
• Patients using Medtronic MiniMed 780G with SmartGuard activated
• Patients whose informed consent has been obtained
• >70% CGM data during observational period

Exclusion criteria

• Patients with partial clinical remission according to the Hvidovre Study Group definition
• Concomitant treatment with steroids or other drugs known to interfere with blood glucose levels
• Previous diagnosis of psychological or eating disorders