The Impact of a Moderate Carbohydrate Diet in Children With Type 1 Diabetes on Hybrid Closed-loop Therapy
- Conditions
- Diabetes Mellitus, Type 1
- Registration Number
- NCT06567158
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Signed informed consent (ICF) (both children/adolescents and parents)<br><br> - =7 and =17 years old at moment of ICF signature<br><br> - =6 months type 1 diabetes diagnosis at moment of ICF signature<br><br> - =3 months use of the hybrid closed-loop system Medtronic MiniMedTM 780G, Tandem<br> t:slim X2 Control-IQTM or Mylife Ypsopump with CamAPS algorithm at moment of ICF<br> signature<br><br> - Ability to understand, read, write and speak Dutch, French or English at moment of<br> ICF signature<br><br>Exclusion Criteria:<br><br> - <7 or >17 years old at moment of ICF signature<br><br> - <6 months type 1 diabetes diagnosis at moment of ICF signature<br><br> - <3 months use of the advanced hybrid closed-loop system Medtronic MiniMedTM 780G,<br> Tandem t:slim X2 Control-IQTM or Mylife Ypsopump with CamAPS algorithm at moment of<br> ICF signature<br><br> - Any other insulin therapy than advanced hybrid closed-loop system Medtronic<br> MiniMedTM 780G , Tandem t:slim X2 Control-IQTM or Mylife Ypsopump with CamAPS<br> algorithm at moment of ICF signature<br><br> - Failure to understand, read, write or speak Dutch, French or English at moment of<br> ICF signature
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time in range
- Secondary Outcome Measures
Name Time Method Active insulin time;Number of people who use glucose target 100 mg/dL, 110 mg/dL and 120 mg/dL;Consumed carbohydrates;Meal composition;Time in tight range;Time below range;Time in level 2 hypoglycemia;Time above range;Time in level 2 hyperglycemia;Hemoglobin A1c;Mean blood glucose;Glycemic variability: standard deviation and coefficient of variation;Daily insulin dose;Number of severe hypoglycemic events;Number of diabetic ketoacidosis;Body weight;Body mass index;Blood lipids (total cholesterol, triglycerides, high density lipoprotein and low density lipoprotein concentrations);Satisfaction with the diet in the context of diabetes treatment;Bioelectrical impedance analysis;Carb ratio