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NCT Number: NCT06567158

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

moderate carbohydrate diet

Other

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.

Traditional diet

Other

During the traditional diet, participants do not follow any diet, however their carbohydrate intake must be at least 50% of their total energy intake.

Primary outcomes

  1. Time in range

    Time frame: 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 outcomes

  1. Time in tight range

    Time frame: 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.

  2. Time below range

    Time frame: 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.

  3. Time in level 2 hypoglycemia

    Time frame: 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.

  4. Time above range

    Time frame: 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.

  5. Time in level 2 hyperglycemia

    Time frame: 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.

  6. Hemoglobin A1c

    Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet

    Difference of hemoglobin A1c between the moderate carbohydrate diet and the traditional diet.

  7. Mean blood glucose

    Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet

    Difference of mean blood glucose between the moderate carbohydrate diet and the traditional diet.

  8. Glycemic variability: standard deviation and coefficient of variation

    Time frame: 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.

  9. Daily insulin dose

    Time frame: 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.

  10. Number of severe hypoglycemic events

    Time frame: 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.

  11. Number of diabetic ketoacidosis

    Time frame: 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.

  12. Body weight

    Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet

    Difference in body weight between the moderate carbohydrate diet and the traditional diet.

  13. Body mass index

    Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet

    Difference in body mass index between the moderate carbohydrate diet and the traditional diet.

  14. Blood lipids (total cholesterol, triglycerides, high density lipoprotein and low density lipoprotein concentrations)

    Time frame: 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.

  15. Satisfaction with the diet in the context of diabetes treatment

    Time frame: 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.

  16. Bioelectrical impedance analysis

    Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet

    Difference in bioelectrical impedance analysis between the moderate carbohydrate diet and the traditional diet.

  17. Carb ratio

    Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet

    Difference in carb ratio between the moderate carbohydrate diet and the traditional diet.

  18. Active insulin time

    Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet

    Difference in active insulin time between the moderate carbohydrate diet and the traditional diet.

  19. Number of people who use glucose target 100 mg/dL, 110 mg/dL and 120 mg/dL

    Time frame: 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.

  20. Consumed carbohydrates

    Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet

    Difference in consumed carbohydrates between the moderate carbohydrate diet and the traditional diet.

  21. Meal composition

    Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet

    Difference in meal composition a between the moderate carbohydrate diet and the traditional diet.

Study contacts

Contact information is provided by the study sponsor or research team.

Kristina Casteels, Prof

CONTACT

[email protected]

+3216343811

Laura Valgaerts

CONTACT

[email protected]

+3216343890

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study 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

Acronym: COMBINE1

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 22, 2024
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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