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RECRUITING
NCT07179471

Fake Carbs Practice With AID System - MiniMed 780G in Children and Adolescents With T1D.

Sponsor: Maria Chatzipsalti

View on ClinicalTrials.gov

Summary

Hybrid Closed Loop (HCL) systems, such as the MiniMed 780G, have significantly improved glycemic outcomes in Type 1 Diabetes (T1D) management. The MiniMed 780G, an Advanced Hybrid Closed Loop (AHCL) system, features autocorrection boluses and unique insulin adjustment technologies. While effective, the system requires user input for meal announcements. Some individuals attempt to "trick" the system by entering "fake carbs" to prompt additional insulin corrections. However, clinical evidence suggests this practice does not improve glycemic outcomes. This study, conducted in Athens, Greece, will involve 40 children and adolescents (ages 7-18) with Type 1 Diabetes who have been using the MiniMed 780G system for over 6 months. The open-label, crossover design explores the impact of 'fake carbohydrates' on glycemic control. Participants will be split into two groups: one starts with 'fake carbohydrates' and then stops, while the other does the reverse. Over two weeks, their glycemic outcomes will be monitored and compared, with exclusions for severe diabetes complications or serious diabetic events This study hypothesizes that using "fake carbs" does not enhance glycemic control. Findings are expected to provide evidence-based insights to optimize diabetes management and improve clinical guidance for HCL system users.

Official title: "Fake Carbs" Practice in the Glycemic Outcomes in Children and Adolescents Using AID System: A Cross-over Observational Study

Key Details

Gender

All

Age Range

7 Years - 19 Years

Study Type

OBSERVATIONAL

Enrollment

40

Start Date

2025-06-04

Completion Date

2025-12-30

Last Updated

2025-09-17

Healthy Volunteers

No

Locations (3)

Athens General Children's Hospital "Pan. & Aglaia Kyriakou"

Athens, Attica, Greece

Athens, Attiki

Athens, Attica, Greece

Diabetes Center

Athens, Attica, Greece