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Recruiting NCT06567158

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

No phase Interventional Diabetes Mellitus, Type 1

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Moderate carbohydrate diet, Traditional diet.
Who it may be relevant to
Registry conditions: Diabetes Mellitus, Type 1. Basic parameters: 7 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Other Moderate carbohydrate diet
    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.
  • Other Traditional diet
    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 outcome measures

  • Time in range [Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet]
Secondary outcome measures (12)
  • Time in tight range [Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet]
  • Time below range [Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet]
  • Time in level 2 hypoglycemia [Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet]
  • Time above range [Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet]
  • Time in level 2 hyperglycemia [Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet]
  • Hemoglobin A1c [Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet]
  • Mean blood glucose [Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet]
  • Glycemic variability: standard deviation and coefficient of variation [Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet]
  • Daily insulin dose [Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet]
  • Number of severe hypoglycemic events [Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet]
  • Number of diabetic ketoacidosis [Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet]
  • Body weight [Time frame: 4 weeks moderate carbohydrate diet and 4 weeks 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

Belgium · 1 center
  • UZ Leuven — Leuven

Identifiers

NCT: NCT06567158 · S68499

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗