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

NCT07179471 | Recruiting

• 1 other identifier: 10862
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Type 1 Diabetes Mellitus

Keywords

AID System; MiniMed 780G; Fake carbs; AHCL System

Outcome Measures

Primary Outcomes (3)

• Change in Time In Range

  Change between groups in blood glucose in Time in Range -TIR ( defined as 70-180 mg/dl) (%)

  2 weeks

• Change in Time in Tight Range

  Change between groups in time in blood glucose in Tight Range -TITR ( defined as 70-140 mg/dl) (%)

  2 weeks

• Change in Time Below Range

  Change between groups in blood glucose in Time Below Range- TBR (defined as \<54mg/dl) (%)

  2 weeks

Secondary Outcomes (12)

• Changes between groups in GMI

  2 weeks

• Changes in Time Above Range

  2 weeks

• Change in mean sensor glucose

  2 weeks

• Change in Standard Deviation of glucose

  2 weeks

• Changes in Coefficient of Variation for glucose

  2 weeks

Study Arms (2)

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

Eligibility Criteria

• Age: 7 Years - 19 Years
• Gender Eligibility Details: All
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants (Age 7-18 years) with T1D using MiniMed 780G system for 6 months at least.

You may qualify if:

• Participants aged 7-18 years
• T1D \>6 months
• on MiniMed 780G system in automode.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maria Chatzipsalti: lead

Study Sites (3)

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

Athens, Attica, 11527, Greece

ACTIVE NOT RECRUITING

Athens, Attiki

Athens, Attica, 11527, Greece

ACTIVE NOT RECRUITING

Diabetes Center

Athens, Attica, 11527, Greece

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Maria Chatzipsalti

CONTACT

+302132009855; endo1ped@aglaiakyriakou.gr

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Pediatrician and Pediatric Endocrinologist-Diabetologist

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: September 17, 2025
• Study Start: June 4, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: September 17, 2025

Record last verified: 2025-09

Locations

GR (3)