Fake Carbs Practice With AID System - MiniMed 780G in Children and Adolescents With T1D.
NCT07179471
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.
Eligibility
Inclusion Criteria: * Participants aged 7-18 years * T1D \>6 months * on MiniMed 780G system in automode. Exclusion Criteria: * Participants with significant diabetes complications * Participants with severe episode of diabetic ketoacidosis in the last 6 months * Participants with hypoglycemia in the last 6 months.
Conditions2
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NCT07179471