Clinical trial NCT06567158: The Impact of a Moderate Carbohydrate Diet in Children With Type 1 Diabetes on Hybrid Closed-loop Therapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2024-08-22
Enrollment: 28
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study will be preceded by a screening period to check which participants are eligible for the study and a two-week run-in period during which, participants will be asked to document their eating patterns for one week in a digital food diary to base the moderate carbohydrate diet on.

Participants will be randomized into two groups (1:1). One group will start at baseline with the traditional diet and after four weeks they will cross-over to the moderate carbohydrate diet for four weeks. The second group will start at baseline with the moderate carbohydrate diet and after four weeks they will crossover to the traditional diet for four weeks. Between the two diet periods there will be a wash-out period of six weeks.
Primary purpose: TREATMENT

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 type 1 diabetes on top of standard insulin administration and glucose monitoring. Despite previous studies, the impact of carbohydrate restriction on glycemic control and quality of life is still not clear. Furthermore, few studies exist on carbohydrate restriction in children with type 1 diabetes and combined with the use of hybrid closed-loop insulin delivery. Therefore this study will determine the impact on glycemic control and the feasability of a moderate carbohydrate diet compared to a traditional diet in children (7-17 years) with type 1 diabetes on top of using a hybrid closed-loop system. In this randomized, crossover study, 28 children will follow a moderate carbohydrate diet (four weeks) and a traditional diet (four weeks) in randomized order. With a run-in period (two weeks) prior to the first diet and a wash-out period (six weeks) between the two diets, the children will participate in the study for a total of 16 weeks. The primary endpoint is the difference of time spent in target range (defined as a sensor glucose value between 70 and 180 mg/dL) between the four-week moderate carbohydrate diet and the four-week traditional diet.


Eligibility 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

Primary outcomes:
measure: Time in range
timeFrame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Secondary outcomes:
measure: Time in tight range
timeFrame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
measure: Time below range
timeFrame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
measure: Time in level 2 hypoglycemia
timeFrame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
measure: Time above range
timeFrame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
measure: Time in level 2 hyperglycemia
timeFrame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
measure: Hemoglobin A1c
timeFrame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
measure: Mean blood glucose
timeFrame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
measure: Glycemic variability: standard deviation and coefficient of variation
timeFrame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
measure: Daily insulin dose
timeFrame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
measure: Number of severe hypoglycemic events
timeFrame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
measure: Number of diabetic ketoacidosis
timeFrame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
measure: Body weight
timeFrame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
measure: Body mass index
timeFrame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
measure: Blood lipids (total cholesterol, triglycerides, high density lipoprotein and low density lipoprotein concentrations)
timeFrame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
measure: Satisfaction with the diet in the context of diabetes treatment
timeFrame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
measure: Bioelectrical impedance analysis
timeFrame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
measure: Carb ratio
timeFrame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
measure: Active insulin time
timeFrame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
measure: Number of people who use glucose target 100 mg/dL, 110 mg/dL and 120 mg/dL
timeFrame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
measure: Consumed carbohydrates
timeFrame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
measure: Meal composition
timeFrame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
Study officials:
affiliation: UZ Leuven
name: Kristina Casteels, Prof
role: PRINCIPAL_INVESTIGATOR
References: