The Impact of a Moderate Carbohydrate Diet in Children With Type 1 Diabetes on Hybrid Closed-loop Therapy

Not Applicable

Recruiting

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Other: Moderate carbohydrate diet; Other: Traditional diet

• Registration Number: NCT06567158
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-15
• Status Verified: 2024-08
• Study First Submitted: 2024-08-14
• Study First Submitted QC: 2024-08-20
• Last Update Submitted: 2024-08-20
• Study First Posted: 2024-08-22
• Last Update Posted: 2024-08-22
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1: 1st Traditional diet, 2nd Moderate carbohydrate diet	Moderate carbohydrate diet	The group that starts with the traditional diet in the first 4-week diet period. After wash-out, this group will start with the moderate carbohydrate diet in the second 4-week diet period.
Group 2: 1st Moderate carbohydrate diet, 2nd Traditional diet	Traditional diet	The group that starts with the traditional diet in the first 4-week diet period. After wash-out, this group will start with the moderate carbohydrate diet in the second 4-week diet period.
Group 2: 1st Moderate carbohydrate diet, 2nd Traditional diet	Moderate carbohydrate diet	The group that starts with the traditional diet in the first 4-week diet period. After wash-out, this group will start with the moderate carbohydrate diet in the second 4-week diet period.
Group 1: 1st Traditional diet, 2nd Moderate carbohydrate diet	Traditional diet	The group that starts with the traditional diet in the first 4-week diet period. After wash-out, this group will start with the moderate carbohydrate diet in the second 4-week diet period.

Primary Outcome Measures

Name	Time	Method
Time in range	4 weeks moderate carbohydrate diet and 4 weeks traditional diet	Difference of time spent in range (70-180 mg/dL) between the moderate carbohydrate diet and the traditional diet.

Secondary Outcome Measures

Name	Time	Method
Time in tight range	4 weeks moderate carbohydrate diet and 4 weeks traditional diet	Difference of time spent in range (70-140 mg/dL) between the moderate carbohydrate diet and the traditional diet.
Time above range	4 weeks moderate carbohydrate diet and 4 weeks traditional diet	Difference of time spent above range (\>180 mg/dL) between the moderate carbohydrate diet and the traditional diet.
Daily insulin dose	4 weeks moderate carbohydrate diet and 4 weeks traditional diet	Difference of insulin doses (total, basal and bolus) between the moderate carbohydrate diet and the traditional diet.
Time in level 2 hyperglycemia	4 weeks moderate carbohydrate diet and 4 weeks traditional diet	Difference of time spent above range of 250 mg/dL between the moderate carbohydrate diet and the traditional diet.
Hemoglobin A1c	4 weeks moderate carbohydrate diet and 4 weeks traditional diet	Difference of hemoglobin A1c between the moderate carbohydrate diet and the traditional diet.
Meal composition	4 weeks moderate carbohydrate diet and 4 weeks traditional diet	Difference in meal composition a between the moderate carbohydrate diet and the traditional diet.
Time in level 2 hypoglycemia	4 weeks moderate carbohydrate diet and 4 weeks traditional diet	Difference of time spent below range of 54 mg/dL between the moderate carbohydrate diet and the traditional diet.
Satisfaction with the diet in the context of diabetes treatment	4 weeks moderate carbohydrate diet and 4 weeks traditional diet	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.
Number of severe hypoglycemic events	4 weeks moderate carbohydrate diet and 4 weeks traditional diet	Difference in the frequency of severe hypoglycemic events between the moderate carbohydrate diet and the traditional diet.
Time below range	4 weeks moderate carbohydrate diet and 4 weeks traditional diet	Difference of time spent below range (\<70 mg/dL) between the moderate carbohydrate diet and the traditional diet.
Mean blood glucose	4 weeks moderate carbohydrate diet and 4 weeks traditional diet	Difference of mean blood glucose between the moderate carbohydrate diet and the traditional diet.
Number of diabetic ketoacidosis	4 weeks moderate carbohydrate diet and 4 weeks traditional diet	Difference in the frequence of diabetic ketoacidosis between the moderate carbohydrate diet and the traditional diet.
Blood lipids (total cholesterol, triglycerides, high density lipoprotein and low density lipoprotein concentrations)	4 weeks moderate carbohydrate diet and 4 weeks traditional diet	Difference in blood lipids (total cholesterol, triglycerides, high density lipoprotein and low density lipoprotein concentrations) between the moderate carbohydrate diet and the traditional diet.
Bioelectrical impedance analysis	4 weeks moderate carbohydrate diet and 4 weeks traditional diet	Difference in bioelectrical impedance analysis between the moderate carbohydrate diet and the traditional diet.
Carb ratio	4 weeks moderate carbohydrate diet and 4 weeks traditional diet	Difference in carb ratio between the moderate carbohydrate diet and the traditional diet.
Active insulin time	4 weeks moderate carbohydrate diet and 4 weeks traditional diet	Difference in active insulin time between the moderate carbohydrate diet and the traditional diet.
Number of people who use glucose target 100 mg/dL, 110 mg/dL and 120 mg/dL	4 weeks moderate carbohydrate diet and 4 weeks traditional diet	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.
Glycemic variability: standard deviation and coefficient of variation	4 weeks moderate carbohydrate diet and 4 weeks traditional diet	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.
Body mass index	4 weeks moderate carbohydrate diet and 4 weeks traditional diet	Difference in body mass index between the moderate carbohydrate diet and the traditional diet.
Body weight	4 weeks moderate carbohydrate diet and 4 weeks traditional diet	Difference in body weight between the moderate carbohydrate diet and the traditional diet.
Consumed carbohydrates	4 weeks moderate carbohydrate diet and 4 weeks traditional diet	Difference in consumed carbohydrates between the moderate carbohydrate diet and the traditional diet.

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium