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

Status: Recruiting
Location: See all (3) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 19
Healthy Volunteers: f
View:

• Participants aged 7-18 years

• T1D \>6 months

• on MiniMed 780G system in automode.

Locations
Other Locations
Greece
Athens General Children's Hospital Pan. & Aglaia Kyriakou
ACTIVE_NOT_RECRUITING
Athens
Athens, Attiki
ACTIVE_NOT_RECRUITING
Athens
Diabetes Center
RECRUITING
Athens
Contact Information
Primary
Maria Chatzipsalti
endo1ped@aglaiakyriakou.gr
+302132009855
Time Frame
Start Date: 2025-06-04
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 40
Treatments
Group 1 (FC1)
20 individuals who use 'fake carbohydrates' to correct hyperglycemia will continue using this strategy for two weeks.
Group 2 (FC2):
20 individuals who use 'fake carbohydrates' to correct hyperglycemia will discontinue this strategy for two weeks
Related Therapeutic Areas
Sponsors
Leads: Maria Chatzipsalti

This content was sourced from clinicaltrials.gov