Effects of a moderate carbohydrate diet on children with type 1 diabetes using hybrid closed-loop therapy
The Impact of Carbohydrate Restriction on Glycemic Control in Children and Adolescents With Type 1 Diabetes Using a Hybrid Closed-loop Insulin Delivery System: a Randomized Cross-over Study
This study tests if a moderate carbohydrate diet can help children with type 1 diabetes using insulin pumps manage their blood sugar better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 7 Years to 17 Years |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Trial ID | NCT06567158 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a moderate carbohydrate diet compared to a traditional diet on glycemic control and quality of life in children aged 7 to 17 years with type 1 diabetes who are using hybrid closed-loop insulin delivery systems. In a randomized, crossover design, 28 participants will follow each diet for four weeks, with a two-week run-in period. The goal is to clarify the impact of carbohydrate restriction in this population, which has been under-researched. The findings could provide insights into dietary management alongside insulin therapy.
Who should consider this trial
Good fit: Ideal candidates are children aged 7 to 17 years with at least six months of type 1 diabetes diagnosis and three months of experience using a hybrid closed-loop insulin delivery system.
Not a fit: Patients who are not using a hybrid closed-loop insulin delivery system or are outside the age range of 7 to 17 years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve glycemic control and quality of life for children with type 1 diabetes.
How similar studies have performed: While there is limited research on carbohydrate restriction in children with type 1 diabetes, previous studies have shown potential benefits in adults, making this approach both novel and promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signed informed consent (ICF) (both children/adolescents and parents) * ≥7 and ≤17 years old at moment of ICF signature * ≥6 months type 1 diabetes diagnosis at moment of ICF signature * ≥3 months use of the hybrid closed-loop system Medtronic MiniMedTM 780G, Tandem t:slim X2 Control-IQTM or Mylife Ypsopump with CamAPS algorithm at moment of ICF signature * Ability to understand, read, write and speak Dutch, French or English at moment of ICF signature Exclusion Criteria: * \<7 or \>17 years old at moment of ICF signature * \<6 months type 1 diabetes diagnosis at moment of ICF signature * \<3 months use of the advanced hybrid closed-loop system Medtronic MiniMedTM 780G, Tandem t:slim X2 Control-IQTM or Mylife Ypsopump with CamAPS algorithm at moment of ICF signature * Any other insulin therapy than advanced hybrid closed-loop system Medtronic MiniMedTM 780G , Tandem t:slim X2 Control-IQTM or Mylife Ypsopump with CamAPS algorithm at moment of ICF signature * Failure to understand, read, write or speak Dutch, French or English at moment of ICF signature
Where this trial is running
Leuven, Vlaams-Brabant
- UZ Leuven — Leuven, Vlaams-Brabant, Belgium (Recruiting)
Study contacts
- Principal investigator: Kristina Casteels, Prof — UZ Leuven
- Study coordinator: Kristina Casteels, Prof
- Email: kristina.casteels@uzleuven.be
- Phone: +3216343811
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.