Comparing glycemic outcomes after missed meal bolus in children with type 1 diabetes using different hybrid closed loop systems
How do the Currently Available HCL Systems Manage Missed Meal Bolus? The Comparison of Glycemic Outcomes After Missed Meal Bolus Between MiniMed 780G, Tandem Control-IQ and Ypsomed CamAPS
This study is testing how different hybrid closed loop systems affect blood sugar levels in children with type 1 diabetes when they miss their meal insulin doses.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 9 Years to 19 Years |
| Sex | All |
| Sponsor | University Hospital, Motol Academic / other |
| Locations | 1 site (Prague) |
| Trial ID | NCT06230276 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to evaluate glycemic outcomes in children and adolescents with type 1 diabetes who miss meal boluses while using different hybrid closed loop (HCL) systems, specifically the Medtronic MiniMed 780G, Tandem Control-IQ, and Ypsomed CamAPS. Participants will receive a controlled amount of enteral nutrition for breakfast on eight different days, with premeal boluses administered for only half of the meals. The study will assess how glycemic responses vary based on the type of HCL system and the insulin analog used. Key metrics include changes in glucose concentration and continuous glucose monitoring parameters.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 9 to 18 years with type 1 diabetes who have been using a hybrid closed loop system for over three months.
Not a fit: Patients who are not using continuous glucose monitoring or those with significant comorbidities affecting glycemia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve management strategies for missed meal boluses in children with type 1 diabetes, leading to better glycemic control.
How similar studies have performed: Other studies have explored glycemic outcomes in type 1 diabetes management, but this specific comparison of HCL systems after missed meal boluses is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * children with type 1 diabetes (CwD) 9.00-18.99 years old * use of continuous glucose monitoring (CGM) \>70% of the time 14 days before a regular check-up in the outpatient clinic * HCL use (MiniMed 780G, Tandem Control-IQ or Ypsomed CamAPS) \>3 months * duration of T1D \>2 years * baseline HbA1c level \<58 mmol/mol (7.5%) * weight \> 30 kilograms * without any medication influencing glycemia (f.e. gliflozins, systemic corticosteroids...) * signed informed consent form with the study
Where this trial is running
Prague
- Motol University Hospital — Prague, Czechia (Recruiting)
Study contacts
- Study coordinator: Alžbeta Šantová, MD
- Email: alzbetkasantova@gmail.com
- Phone: +420 773 707 270
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.