Fake-carb entries with the MiniMed 780G in children and adolescents with type 1 diabetes
"Fake Carbs" Practice in the Glycemic Outcomes in Children and Adolescents Using AID System: A Cross-over Observational Study
This test will see if entering 'fake' carbohydrate amounts into the MiniMed 780G changes blood sugar control in children and adolescents (ages 7–18) with type 1 diabetes who already use the device.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 7 Years to 19 Years |
| Sex | All |
| Sponsor | Athens General Children's Hospital "Pan. & Aglaia Kyriakou" Academic / other |
| Locations | 3 sites (Athens, Attica and 2 other locations) |
| Trial ID | NCT07179471 on ClinicalTrials.gov |
What this trial studies
This open-label, randomized crossover trial in Athens enrolls 40 children and adolescents (7–18 years) with type 1 diabetes who have been using the MiniMed 780G in automode for at least six months and habitually enter fake carbohydrates. Participants are randomized to a sequence of continuing versus stopping fake-carb entry, with each intervention phase lasting two weeks and separated by run-in and washout periods to allow algorithm adaptation. Continuous glucose outcomes (for example time-in-range and hyper/hypoglycemia metrics) during the fake-carb and no-fake-carb periods will be compared within each participant. The design aims to directly measure whether the common user behavior of entering fake carbs leads to meaningful changes in glucose control among pediatric users.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 7–18 with type 1 diabetes who have been using the MiniMed 780G in automode for at least six months and who habitually enter fake carbohydrates.
Not a fit: Patients who do not use the MiniMed 780G, are outside the 7–18 age range, or have recent severe complications (recent DKA or severe hypoglycemia) are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, the results could clarify whether fake-carb entry helps or harms glucose control and guide clearer self‑management advice for families using the MiniMed 780G.
How similar studies have performed: Previous clinical reports and analyses generally show that entering fake carbohydrates does not improve glycemic outcomes, and randomized pediatric crossover data on this behavior are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Athens, Attica and 2 other locations
- Athens General Children's Hospital "Pan. & Aglaia Kyriakou" — Athens, Attica, Greece (Active_not_recruiting)
- Athens, Attiki — Athens, Attica, Greece (Active_not_recruiting)
- Diabetes Center — Athens, Attica, Greece (Recruiting)
Study contacts
- Study coordinator: Maria Chatzipsalti
- Email: endo1ped@aglaiakyriakou.gr
- Phone: +302132009855
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.