Status:
RECRUITING
The Impact of a Moderate Carbohydrate Diet in Children With Type 1 Diabetes on Hybrid Closed-loop Therapy
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
7-17 years
Phase:
NA
Brief Summary
In the past, carbohydrate restriction was indicated as a treatment for people with type 1 diabetes when exogenous insulin was not available. Now it is mainly used as an added treatment for people with...
Eligibility Criteria
Inclusion
- 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
- \<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
Key Trial Info
Start Date :
May 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT06567158
Start Date
May 15 2024
End Date
December 31 2025
Last Update
August 22 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000