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

NCT06567158 | Recruiting

• 1 other identifier: S68499
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• Time in range

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

  4 weeks moderate carbohydrate diet and 4 weeks traditional diet

Secondary Outcomes (21)

• Time in tight range

  4 weeks moderate carbohydrate diet and 4 weeks traditional diet

• Time below range

  4 weeks moderate carbohydrate diet and 4 weeks traditional diet

• Time in level 2 hypoglycemia

  4 weeks moderate carbohydrate diet and 4 weeks traditional diet

• Time above range

  4 weeks moderate carbohydrate diet and 4 weeks traditional diet

• Time in level 2 hyperglycemia

  4 weeks moderate carbohydrate diet and 4 weeks traditional diet

Study Arms (2)

Group 1: 1st Traditional diet, 2nd Moderate carbohydrate diet

EXPERIMENTAL

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.

Other: Moderate carbohydrate diet; Other: Traditional diet

Group 2: 1st Moderate carbohydrate diet, 2nd Traditional diet

EXPERIMENTAL

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.

Other: Moderate carbohydrate diet; Other: Traditional diet

Interventions

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.

Group 1: 1st Traditional diet, 2nd Moderate carbohydrate diet; Group 2: 1st Moderate carbohydrate diet, 2nd Traditional diet

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.

Group 1: 1st Traditional diet, 2nd Moderate carbohydrate diet; Group 2: 1st Moderate carbohydrate diet, 2nd Traditional diet

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Kristina Casteels, Prof

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristina Casteels, Prof

CONTACT

+3216343811; kristina.casteels@uzleuven.be

Laura Valgaerts

CONTACT

+3216343890; laura.valgaerts@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 22, 2024
• Study Start: May 15, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 22, 2024

Record last verified: 2024-08

Locations

BE (1)