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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
During the moderate carbohydrate diet, participants will be asked to limit his/her carbohydrate intake to no more than 30% of their total energy intake.
During the traditional diet, participants do not follow any diet, however their carbohydrate intake must be at least 50% of their total energy intake.
UZ Leuven
Leuven, Vlaams-Brabant, Belgium
RECRUITINGTime in range
Difference of time spent in range (70-180 mg/dL) between the moderate carbohydrate diet and the traditional diet.
Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Time in tight range
Difference of time spent in range (70-140 mg/dL) between the moderate carbohydrate diet and the traditional diet.
Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Time below range
Difference of time spent below range (\<70 mg/dL) between the moderate carbohydrate diet and the traditional diet.
Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Time in level 2 hypoglycemia
Difference of time spent below range of 54 mg/dL between the moderate carbohydrate diet and the traditional diet.
Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Time above range
Difference of time spent above range (\>180 mg/dL) between the moderate carbohydrate diet and the traditional diet.
Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Time in level 2 hyperglycemia
Difference of time spent above range of 250 mg/dL between the moderate carbohydrate diet and the traditional diet.
Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Hemoglobin A1c
Difference of hemoglobin A1c between the moderate carbohydrate diet and the traditional diet.
Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Mean blood glucose
Difference of mean blood glucose between the moderate carbohydrate diet and the traditional diet.
Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Glycemic variability: standard deviation and coefficient of variation
Difference of glycemic variability, in terms of standard deviation (SD) and coefficient of variation (CV) of blood glucose levels between the moderate carbohydrate diet and the traditional diet.
Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Daily insulin dose
Difference of insulin doses (total, basal and bolus) between the moderate carbohydrate diet and the traditional diet.
Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Number of severe hypoglycemic events
Difference in the frequency of severe hypoglycemic events between the moderate carbohydrate diet and the traditional diet.
Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Number of diabetic ketoacidosis
Difference in the frequence of diabetic ketoacidosis between the moderate carbohydrate diet and the traditional diet.
Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Body weight
Difference in body weight between the moderate carbohydrate diet and the traditional diet.
Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Body mass index
Difference in body mass index between the moderate carbohydrate diet and the traditional diet.
Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Blood lipids (total cholesterol, triglycerides, high density lipoprotein and low density lipoprotein concentrations)
Difference in blood lipids (total cholesterol, triglycerides, high density lipoprotein and low density lipoprotein concentrations) between the moderate carbohydrate diet and the traditional diet.
Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Satisfaction with the diet in the context of diabetes treatment
Difference in the satisfaction with the diet (Diabetes treatment satisfaction questionnaire - DTSQs) between the moderate carbohydrate diet and the traditional diet. The DTSQs has a scale of 0-48 and a higher score is associated with a higher treatment satifaction.
Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Bioelectrical impedance analysis
Difference in bioelectrical impedance analysis between the moderate carbohydrate diet and the traditional diet.
Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Carb ratio
Difference in carb ratio between the moderate carbohydrate diet and the traditional diet.
Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Active insulin time
Difference in active insulin time between the moderate carbohydrate diet and the traditional diet.
Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Number of people who use glucose target 100 mg/dL, 110 mg/dL and 120 mg/dL
Difference in umber of people who use glucose target 100 mg/dL, 110 mg/dL and 120 mg/dL between the moderate carbohydrate diet and the traditional diet.
Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Consumed carbohydrates
Difference in consumed carbohydrates between the moderate carbohydrate diet and the traditional diet.
Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Meal composition
Difference in meal composition a between the moderate carbohydrate diet and the traditional diet.
Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
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